POPULAR PHARMACEUTICALS LTD.

SOP List

Huaman Resources

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

1 Manpower Requisition HR/001/00 00 10.05.23 09.05.28

2 Training Requisition HR/002/00 00 10.05.23 09.05.28
3 Post Training Report HR/003/00 00 24.06.23 23.06.28

Prepared By: Checked By: Approved By:

Md. shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA
POPULAR PHARMACEUTICALS LTD.

SOP List

Information Technology

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

1 SAP Server Backup and Restoration IT/001/00 00 21.06.22 20.06.27

2 Access Management for SAP IT/002/00 00 21.06.22 20.06.27
3 User Account Creation and Maintenance IT/003/00 00 21.06.22 20.06.27
4 User System Security and Access Control IT/004/00 00 21.06.22 20.06.27
5 Data Backup IT/005/00 00 21.06.22 20.06.27
6 Logical Security IT/006/00 00 21.06.22 20.06.27
7 Addition and Removal of Authorization IT/007/00 00 21.06.22 20.06.27

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA
POPULAR PHARMACEUTICALS LTD.

SOP List

Safety

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

1 Site Safety Management SF/001/03 03 25.05.19 24.05.24

2 Internal Safety Inspection of Workplace SF/002/04 04 02.12.20 01.12.25
Operation and Maintenance of Fire Detection and Fighting
3 SF/003/04 04 06.01.19 05.01.24
System

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA
POPULAR PHARMACEUTICALS LTD.

SOP List

Training

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

1 Training of Factory Employees TR/001/05 05 29.12.20 28.12.25

2 Assessment of Training Effectiveness TR/002/00 00 13.04.19 12.04.24

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA
POPULAR PHARMACEUTICALS LTD.

SOP List

Administration

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

1 Health Check Programme AD/001/04 04 18.11.20 17.11.25

2 Sickness Reporting AD/002/04 04 18.06.19 17.06.24
3 Pest Control AD/004/08 08 05.05.20 04.05.25
4 Incident Reporting AD/007/02 02 25.05.19 24.05.24
Arrangement of Transport Facilities for Movement of
5 Quality Assuranceand Quality Control Personnel to AD/008/00 00 23.05.21 22.05.26
Hormone Facilities from Quality Assurance/Quality Control
Area and Coming Back from There

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA
POPULAR PHARMACEUTICALS LTD.

SOP List

Warehouse

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

1 Receipt and Storage of Raw Materials WH/001/08 08 01.07.19 30.06.24

2 Receipt and Storage of Packaging Materials WH/002/06 06 01.07.19 30.06.24
3 Issuance of Packaging Materials WH/003/06 06 31.01.20 30.01.25
4 Warehouse Controls WH/005/05 05 04.04.23 03.04.28
Monitoring of Temperature and Relative Humudity in
5 WH/010/09 09 01.03.21 28.02.26
Warehouse
6 Receipt and Storage of API of Cephalosporin WH/014/03 03 01.11.19 31.10.24
7 Receipt and Storage of API of Penicillin WH/015/03 03 01.11.19 31.10.24
Receipt and Storage of Raw Materials for Toll
8 WH/018/03 03 01.02.20 31.01.25
Manufacturing Products
Receipt and Storage of Packaging Materials for Toll
9 WH/020/02 02 30.05.19 29.05.24
Manufacturing Products
10 De-dusting of Incoming Materials at the time of Receiving WH/025/03 03 27.02.23 26.02.28
11 Cleaning of Warehouse WH/026/05 05 29.02.20 28.02.25
Monitoring of Temperature and Relative Humidity in
12 WH/036/05 05 01.03.21 28.02.26
Cephalosporin Store
13 Receipt and Storage of Potent Drug API WH/041/04 04 01.11.19 31.10.24
Issuance of Packaging Materials for Toll Manufacturing
14 WH/044/03 03 31.01.20 30.01.25
Product
Supply of Raw Materials (Toll) from Warehouse to
15 WH/045/01 01 31.10.18 30.10.23
Dispensing Area
Issuance of Raw and Packaging Materials from PPL to
16 WH/046/01 01 06.05.19 05.05.24
GPL Warehouse
Operation, Function Check and Cleaning of Balance-
17 WH/047/01 01 01.01.19 31.12.23
OHAUS 300 Kg [ Model D51P300QX2 ]
18 Cleaning of Warehouse- CT WH/048/01 01 07.07.20 06.07.25
Monitoring of Temperature and Relative Humudity in
19 WH/049/01 01 07.07.20 06.07.25
Warehouse- CT
Operation, Function Check and Cleaning of Warehouse
20 WH/050/01 01 27.02.19 26.02.24
Balance (RFL)
21 Personnel Entry,Exit and Gowning in Warehouse WH/052/01 01 16.02.23 15.02.28
22 Operation and Cleaning of Vacuum cleaner WH/053/00 00 16.03.23 15.03.28
23 Operation and Cleaning of Walk floor scrubber drier WH/054/00 00 16.03.23 15.03.28
24 Operation and Cleaning of Static Pass Box WH/055/00 00 22.06.23 21.06.28

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA
POPULAR PHARMACEUTICALS LTD.

SOP List

Dispensing

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

1 Dispensing of Raw Materials DP/001/06 06 30.08.19 29.08.24

2 Cleaning and Storage of Utensils used for Dispensing DP/002/05 05 06.02.19 05.02.24
Operation, Cleaning and Maintenance of Dispensing Booth
3 DP/003/06 06 30.08.19 29.08.24
[Model CPP 1950]
4 Cleaning of Dispensing Room DP/004/05 05 30.08.19 29.08.24
Personnel Entry/Exit and Gowning Procedure for Dispensing
5 DP/005/05 05 06.02.19 05.02.24
Area
6 Cleaning of Wash Bay of Dispensing Area DP/006/04 04 30.08.19 29.08.24
7 Cleaning of Change Room at Dispensing Area DP/007/04 04 30.08.19 29.08.24
General Procedure for Maintenance and Cleaning of
8 DP/008/04 04 30.08.19 29.08.24
Dispensing Area
Change Over Clearance for the Room for Dispensing of Raw
9 DP/009/04 04 30.08.19 29.08.24
Materials
Operation, Function check, Weighing, Maintenance and
10 DP/013/03 03 06.04.19 05.04.24
Cleaning of Electronic Balance Shimadzu [Model BX32KH]
Operation, Function Check, Weighing, Maintenance and
11 DP/014/03 03 06.04.19 05.04.24
Cleaning of Electronic Balance Shimadzu [Model Tx323 L)
Operation, Function Check, Weighing, Maintenance and
12 Cleaning of Electronic Balance DINI ARGEO DP/015/01 01 06.04.19 05.04.24
[Model PBE 150]

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA
POPULAR PHARMACEUTICALS LTD.

SOP List

Cephalosporins

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

Personnel entry/exit and gowning through Primary Change

1 CP/001/07 07 24.06.23 23.06.28
Room of Manufacturing Area
Personnel entry/exit and gowning through Secondary Change
2 CP/002/06 06 28.10.20 27.10.25
Room of Packaging Area
Operation and Cleaning of Dry Heat Sterilizer, Macofar
3 CP/003/05 05 03.06.20 02.06.25
Model: T600 H1 C1
Operation and Cleaning of Vial Washing Machine, Macofar
4 CP/004/05 05 03.06.20 02.06.25
Model: W600-8
Action taken in case of Power/Air Condition failure during
5 CP/005/05 05 06.06.20 05.06.25
Aseptic Filling
Operation and Cleaning of Autoclave, Celestar Model
6 CP/006/04 04 12.06.20 11.06.25
: Sterimega 350+GVP 100I
Operation and Cleaning of Powder Filling and Stoppering
7 CP/007/05 05 03.06.20 02.06.25
Machine Macofar Model: Micro 9
8 Cleaning and Maintenance of Aseptic Filling Room CP/008/05 05 05.06.20 04.06.25
9 Operation and Cleaning of Pass Box CP/009/05 05 24.05.20 23.05.25
10 Washing of Clean Room Dress CP/010/05 05 05.06.20 04.06.25
Operation and Cleaning of Cap Sealing Machine, Macofar
11 CP/011/03 03 06.06.19 05.06.24
Model: CSP10
Operation and Cleaning of Semi-Automatic Rotary Bottle
12 CP/012/05 05 07.06.20 06.06.25
Washing and Drying Machine, Model: YC-BW-18B
Operation and Cleaning of Automatic Powder Filling Machine,
13 CP/013/05 05 07.06.20 06.06.25
Model: JC-PF-2
Operation and Cleaning of Automatic Cap Sealing Machine,
14 CP/014/05 05 07.06.20 06.06.25
Model: JC-CA
Operation and Cleaning of Hoong-A Blister Packing Machine,
15 CP/015/05 05 23.05.20 22.05.25
(Model: Ministar V6)
Operation and Cleaning of SEJONG Automatic Capsule Filling
16 CP/016/04 04 24.05.20 23.05.25
Machine, (Model: SF-40N)
Operation, Function Check, Maintenance and Cleaning of
17 CP/017/03 03 06.06.19 05.06.24
Dispensing Balance Sartorius [Model EA150FEG-I]
Operation and Cleaning of Cosmec Blender,
18 CP/018/02 02 06.06.19 05.06.24
Model: MBG 20/10 BC
19 Operation and Cleaning of Drum Blender CP/019/02 02 07.06.19 06.06.24
20 Receipt of Raw Materials and Packaging Materials CP/020/02 02 07.06.19 06.06.24
21 Cleaning of Cephalosporin Production Area CP/021/03 03 18.05.23 17.05.28
22 General Procedure for Packing CP/022/02 02 07.06.19 06.06.24
Operation and Cleaning of Rotary Tablet Compression
23 CP/024/03 03 10.01.20 09.01.25
Machine, Model: NRIR-13D

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

8 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Cephalosporins

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

24 Cleaning of Coating Room CP/025/03 03 06.12.19 05.12.24

25 Cleaning of Encapsulation Room CP/026/03 03 06.12.19 05.12.24
26 Cleaning of Compression Room CP/027/03 03 06.12.19 05.12.24
27 Cleaning of Blending Room CP/028/03 03 06.12.19 05.12.24
28 Cleaning of Powder Filling Room CP/029/03 03 06.12.19 05.12.24
29 Cleaning of Mesh CP/030/03 03 15.01.20 14.01.25
30 Operation and Cleaning of Ink Jet Printing Machine CP/031/02 02 15.05.23 14.05.28
31 Visual Inspection of Filled Vials & Ampoules CP/032/02 02 08.05.23 07.05.28
32 Operation of KK & KK (KK-570) Carton Printing Machine CP/033/02 02 14.04.23 13.04.28
Operation, Function Check, Maintenance and Cleaning of
33 CP/034/02 02 11.05.23 10.05.28
Electronic Balance DINI ARGEO [Model PBE 150]
Operation and Cleaning of Hoonga Blister Machine
34 CP/035/02 02 09.03.23 08.03.28
[Model Ministar V6]
35 Cleaning of Vacuum Cleaner CP/036/02 02 16.05.23 15.05.28
Operation, Function Check, Weighing, Maintenance and
36 CP/037/01 01 08.11.18 07.11.23
Cleaning of Electronic Balance Shimadzu [Model TX223L]
Operation, Function Check, Weighing, Maintenance and
37 CP/038/01 01 08.11.18 07.11.23
Cleaning of Electronic Balance Shimadzu [Model TX3202L]
Operation, Function Check, Weighing, Maintenance and
38 CP/039/01 01 08.11.18 07.11.23
Cleaning of Electronic Balance Shimadzu [Model TX323L]
Operation, Function Check, Weighing, Maintenance and
39 Cleaning of Electronic Balance Mettler Toledo CP/040/01 01 08.11.18 07.11.23
[Model PB303-S]
Operation and Cleaning of ETI PACK Vial Labveling
40 CP/041/01 01 13.01.19 12.01.24
Machine, [Model : S1FORIGINAL13]
Operation, Function Check, Maintenance and Cleaning of
41 CP/042/01 01 04.04.20 03.04.25
Electronic Balance NAGATA [Model CYT-12]
42 Operation and Cleaning of Yenchen Film Coating Machine CP/043/01 01 19.04.20 18.04.25
Operation, Function Check, Maintenance and Cleaning of
43 CP/044/00 00 26.09.19 25.09.24
Electronic Balance NAGATA [Model TW-RL10]
Opertion, Function Check, Maintenance and Cleaning pf
44 CP/045/00 00 18.05.20 17.05.25
Electronic Balance Shimadzu [Model TX423L]
45 Operation and Cleaning of Multi Mill CP/046/00 00 26.05.22 25.05.27
Operation and Cleaning of Hologram Sticker Labeling
46 CP/047/00 00 26.12.22 25.12.27
Machine (Model: AL320)
47 Operation & Cleaning of Gansons Comminuting Mill CP/048/00 00 19.01.23 18.01.28
Operation, Function Check, Weighing and Cleaning of
48 Electronic Balance Minebea Intec Combics 3 [Model CP/049/00 00 29.01.23 28.01.28
CAW3P1-150GF-I]

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

9 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Cephalosporins

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

49 Entry/Exit and Cleaning of Shoe Change Room CP/050/00 00 27.02.23 26.02.28

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

10 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Penicillin

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

Operation, Function Check, Maintenance and Cleaning of

1 PN/002/01 01 27.04.19 26.04.24
Electronic Balance Shimadzu [Model TX220L]
Operation and Cleaning of Hauser Auger Semi Auto Powder
2 PN/003/01 01 31.07.20 30.07.25
Filling Machine
Personnel Entry/Exit and Gowning Procedure at Penicillin
3 PN/004/01 01 06.03.19 05.03.24
Facility
Operation and Cleaning of Semi Automatic Cap Sealing
4 PN/005/01 01 31.07.20 30.07.25
Machine
5 Operation & Cleaning of Drum Blender PN/006/01 01 31.07.20 30.07.25
6 Operation & Cleaning of Sifter (Gansons) Machine PN/007/01 01 31.07.20 30.07.25
7 Cleaning of Mesh PN/008/01 01 31.07.20 30.07.25
8 Cleaning of Blending Room PN/009/01 01 31.07.20 30.07.25
9 Cleaning of Encapsulation Room PN/010/01 01 31.07.20 30.07.25
Operation and Cleaning of Pharma Chem Manual
10 PN/011/01 01 31.07.20 30.07.25
Encapsulation Machine (Model-SS-316)
11 Operation and Cleaning of Automatic Capsule Loader PN/012/01 01 31.07.20 30.07.25
12 Operation and Cleaning of Double Cone Blender PN/013/01 01 31.07.20 30.07.25
13 General Procedure of Manufacturing at Penicillin Facility PN/014/01 01 31.07.20 30.07.25
14 General Cleaning of Production Floor PN/015/01 01 31.07.20 30.07.25
Street Shoe Change Before Entry/Exit through Main Door &
15 PN/016/00 00 01.03.19 29.02.24
Gowning Through Primary Change Room of Penicillin Area
Operation and Cleaning of Automatic Injectable Powder
16 PN/017/00 00 24.12.18 23.12.23
Filliing and Rubber Stoppering Machine

17 PN/019/00 00 05.01.19 04.01.24

Operation and Cleaning of PyroMega Autoclave Model : 1000
18 Cleaning and Disinfection of Penicillin Area PN/020/00 00 25.12.18 24.12.23
Operation, Function Check, Maintenance and Cleaning of
19 PN/021/00 00 05.01.19 04.01.24
Dispensing Balance Shimadzu [Model TX323L]
20 Visual Inspection of Filled Vials PN/022/00 00 27.12.18 26.12.23
Action Taken in Case of Power/Air Condition Failure for
21 PN/023/00 00 28.12.18 27.12.23
Pennicillin Filling Area
Cleaning of Process related Equipments and Contact Parts
22 PN/024/00 00 05.01.19 04.01.24
of Filling and Stoppering Matchine
23 General Packaging in Penicillin Area PN/025/00 00 28.12.18 27.12.23
Operation, Function Check, Weighing, Maintenance and
24 Cleaning of Electronic Weighing Balance Jadever [Model JWI- PN/027/00 00 05.01.19 04.01.24
700W]
25 Operation and Cleaning of Multi mill PN/028/00 00 12.01.19 11.01.24

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

11 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Penicillin

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

Personnel Entry/Exit and Gowning through Filling Area

26 PN/029/00 00 01.03.19 29.02.24
Change Room
27 General Housekeeping of Penicillin Packaging Area PN/030/00 00 28.02.19 27.02.24
28 General Filling Inspection And Packaging in Penicillin Area PN/031/00 00 01.03.19 29.02.24
Operation and Cleaning of Vial cap Sealing Machine ,Mark
29 PN/032/00 00 02.03.19 01.03.24
Industries Model:PPM-35
30 Disposal of Rejected Penicillin Powder Filled Vials PN/033/00 00 28.02.19 27.02.24
Operation and Cleaning of Dispensing Booth at Penicillin
31 PN/034/00 00 06.03.19 05.03.24
Facility
Operation and Cleaning of Bottle Washing and Bottle Dryer
32 PN/035/00 00 05.03.19 04.03.24
Machine at Penicillin Facility
Operation of PG (PZ-40) Encapsulation Machine at Peniccilin
33 PN/036/00 00 11.03.21 10.03.26
Facility
Cleanining of PG (PZ-40) Encapsulation Machine at Peniccilin
34 PN/037/00 00 11.03.21 10.03.26
Facility
Operation and Cleaning of Automatic Vertical Ultrasonic Vial
35 PN/038/00 00 05.06.22 04.06.27
Washing Machine, Model: QCL-60
Operation and Cleaning of Automatic Sicker Labeling
36 PN/039/00 00 02.06.22 01.06.27
Machine, Model: TB-200
Operation and Cleaning of Celester Autoclave Model: SM
37 PN/040/00 00 07.07.22 06.07.27
350+GVP 100I

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

12 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

LVP

Sl Revision Effective Review

Title SOP No.
No. No. Date Date

1 General Activity in LVP Clean Room IV/001/04 04 08.09.18 07.09.23

2 Dress Selection for Clean Room IV/002/05 05 29.04.20 28.04.25
Personnel Entry/Exit & Gowning through Manufacturing Change
3 IV/003/06 06 04.04.19 03.04.24
Room
4 Operation of Air Shower IV/004/03 03 31.08.18 30.08.23
5 Cleaning of Clean Area IV/005/03 03 10.08.18 09.08.23
6 Preperation of Cleaning Solution IV/006/04 04 09.08.18 08.08.23
7 Dispensing of Raw Materials IV/007/04 04 31.08.18 30.08.23
8 Operation and Cleaning of Dispensing Booth IV/008/03 03 31.08.18 30.08.23
9 Operation & Cleaning of Digital Electronic Weighing Balances IV/009/04 04 31.08.18 30.08.23
Manufacturing of LVP Products in 3500 Liter manufacturing
10 IV/010/05 05 29.04.20 28.04.25
Vessel
11 Operation and Cleaning of 3500 Liter Manufacturing Vessel IV/011/04 04 24.08.18 23.08.23
CIP and SIP of 3500 Liter Manufacturing Vessel, Filter Line and
12 IV/012/04 04 24.08.18 23.08.23
Product Transfer Line and 100 Liter Buffer Tank
Operation and Changeover of Bag Form-Fill-Seal Machine
13 IV/014/04 04 24.08.18 23.08.23
Plumat Model No. FFS892; ID. No. : 560-LVP-419-01
14 CIP and SIP of Bag Form Fill Seal Machine IV/015/04 04 25.08.18 24.08.23
Orientation of Different Types LVP Bags, Bottles & Vials in
15 IV/017/03 03 30.08.18 29.08.23
Autoclave Trays and Trolley
16 Visual Inspection of LVP Products IV/019/03 03 25.08.18 24.08.23
17 Flushing of PW & WFI at User Point IV/020/04 04 31.08.18 30.08.23
Operation and Cleaning of 500 Liter Manufacturing Vessel,
18 IV/021/03 03 25.08.18 24.08.23
Id: 460-LVP-493-01
19 General Guideline for Packaging Area IV/022/03 03 26.08.18 25.08.23
Personnel Entry/Exit and Gowning through Packaging Change
20 IV/024/08 08 16.03.23 15.03.28
Room
21 Cleaning of Packaging Area IV/025/03 03 26.08.18 25.08.23
22 Dispensing of Packaging Materials IV/026/03 03 26.08.18 25.08.23
23 Packaging Instruction of Individual Bulk Product IV/027/03 03 26.08.18 25.08.23
24 Operation of Visual Inspection Conveyor IV/029/04 04 26.08.18 25.08.23
25 Overbag Wrapping and Leaflet Inserting IV/030/04 04 28.08.18 27.08.23

Prepared By: Checked By: Approved By:

Md. shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

13 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

LVP

Sl Revision Effective Review

Title SOP No.
No. No. Date Date

26 Operation of Bag Overwraping Conveyor IV/031/04 04 28.08.18 27.08.23

27 Operation of Overbag Sealing Machine IV/032/03 03 28.08.18 27.08.23
28 Inner Cartoning, Master Cartoning and Palleting IV/033/04 04 28.08.18 27.08.23
29 LVP Equipment and Room Cleaning Usage Logbook IV/035/03 03 31.08.18 30.08.23
30 CIP and SIP of 50 Liter Manufacturing Vessel IV/036/04 04 28.08.18 27.08.23
31 CIP and SIP of 500 Liter Manufacturing Vessel and Filter Line IV/037/04 04 28.08.18 27.08.23
CIP and SIP of 500 Liter Storage Vessel and Product Transfer
32 IV/038/04 04 28.08.18 27.08.23
Line
33 CIP and SIP of Plumat Filling Machine Id No. 556-AMN-593-01 IV/039/04 04 28.08.18 27.08.23
Operation of 500 Liter and 50 Liter Manufacturing Vessel
34 IV/040/04 04 28.08.18 27.08.23
(Amiono Acid)
35 Manufacturing of LVP Products (Amino Acid) IV/041/04 04 28.08.18 27.08.23
36 Operation of Bottle Washing Machine IV/042/04 04 28.08.18 27.08.23
Filling, Rubber Stoppering and Flip off Sealing Operations of
37 IV/043/04 04 28.08.18 27.08.23
Amino Acid
38 Dispensing of Fat Emulsion Raw Materials IV/044/04 04 27.08.18 26.08.23
CIP and SIP of Fat Emulsion Manufacturing Vessel and Filter
39 IV/045/04 04 27.08.18 26.08.23
Line
40 CIP and SIP of Fat Emulsion Filling and Cap Sealing Machine IV/046/04 04 29.08.18 28.08.23
41 Manufacturing Operations of Fat Emulsion IV/047/04 04 29.08.18 28.08.23
42 Operation and Cleaning of Homogenizer IV/048/04 04 29.08.18 28.08.23

43 Operation and Cleaning of PDC Filling and Cap Sealing Machine IV/049/04 04 29.08.18 28.08.23

Cleaning of Manufacturing Vessels, Filter Unit, Product Transfer

44 IV/051/02 02 30.08.18 29.08.23
Line and Filling Machine during Product Change Over
Operation and Cleaning of Ambica Vial Filling, Rubber
45 Stoppering and Cap Sealing Machine, Id: 560-AMN-417-02 and IV/052/04 04 30.08.18 29.08.23
560-AMN-417-01
Operation and Cleaning of Celester Autoclave Model : SM
46 IV/053/04 04 30.08.18 29.08.23
350+GVP 100I, Id: 590-LVP-423-01
Operation and Cleaning of Pyromega Autoclave Model : 1000,
47 IV/054/04 04 30.08.18 29.08.23
Id: 490-LVP-424-01

Prepared By: Checked By: Approved By:

Md. shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

14 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

LVP

Sl Revision Effective Review

Title SOP No.
No. No. Date Date

Operation and Cleaning of Vial Washing Machine, Ambica Model

48 IV/055/04 04 30.08.18 29.08.23
: ARVW-120,Id: 590-LVP-422-01
General Procedure of PVC bag Receiving, Carrying and Return
49 IV/056/03 03 30.08.18 29.08.23
from Bag Making area to Filling Area
50 Operation and Cleaning of Desktop Filling Machine IV/057/03 03 31.08.18 30.08.23
51 General Procedure for LVP Manufacturing IV/058/03 03 31.08.18 30.08.23
Infusion Wastage, Reject Packaging Materials, Product
52 IV/059/03 03 22.03.20 21.03.25
Management and Disposal System
CIP and SIP of 500 Liter Manufacturing Vessel , Id: 460-LVP-
53 IV/060/03 03 01.09.18 31.08.23
491-02, Filter Line and Product Transfer Line
Operation and Cleaning of DN Semi Automatic Washing
54 IV/061/03 03 01.09.18 31.08.23
Machine, Model XP-60
55 Operation and Cleaning of Ambica Glue Labeling Machine IV/062/02 02 01.09.18 31.08.23
56 Operation and Cleaning of Image Printer/Ink jet Printer IV/063/02 02 04.09.18 03.09.23
57 Operation and Cleaning of CVC Printing Machine IV/064/02 02 04.09.18 03.09.23
Personnel Entry/Exit & Gowning through Bag Making Change
58 IV/065/02 02 02.09.18 01.09.23
Room
59 Cleaning of Bag Making and Storage Area IV/066/02 02 02.09.18 01.09.23
60 General Guide Line for Bag Making and Storage Room IV/067/02 02 02.09.18 01.09.23
Handling of Production Operations in case of Power/HVAC
61 IV/068/02 02 03.09.18 02.09.23
Failure
Operation and Cleaning of High Frequency Plastic Welding
62 IV/069/02 02 03.09.18 02.09.23
Machine
Operation and Cleaning of Automatic Single Head Cap Sealing
63 IV/070/01 01 21.12.19 20.12.24
Machine, Model No. : MPEC-40
Operation and Cleaning of Automatic Wet Glue Labeling
64 IV/071/01 01 21.12.19 20.12.24
Machine, Model No. : MPEL-150
65 Operation and Cleaning of Filter Dryer Oven IV/072/01 01 21.03.20 20.03.25
Trolley Evacuation and Palleting Procedure after Terminal
66 IV/073/01 01 21.03.20 20.03.25
Sterilization
Personnel Entry/Exit and Gowning Through Bottle/Vial Washing
67 IV/074/01 01 04.04.19 03.04.24
Change Room
68 Washing of Rubber Stopper and Stopper for Infusion Bag IV/075/01 01 12.04.20 11.04.25
Calibration, Operation & Cleaning of pH Meter of Mettler Toledo
69 IV/076/00 00 05.04.19 04.04.24
Model S210

Prepared By: Checked By: Approved By:

Md. shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

15 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

LVP

Sl Revision Effective Review

Title SOP No.
No. No. Date Date

Operation and Cleaning of Palltronic Flow Star Tester in LVP

70 IV/077/01 01 21.06.23 20.06.28
Facility, Model :IVFFS04S
71 Operation and Cleaning of Drucker Inkjet Printer IV/078/00 00 13.11.19 12.11.24
72 Operation and Cleaning of 4000 Liter Manufacturing Vessel IV/079/00 00 05.01.20 04.01.25

CIP, SIP and Operataion of Plumat PVC Bag Filling and Sealing
73 IV/080/00 00 03.01.21 02.01.26
Machine, Model No.: 410-LVP-419-02 and 410-LVP-419-03
74 Operation and Cleaning of Dynamic Pass Box IV/081/00 00 03.03.21 02.03.26
Operation of Superheated Water Spray Autoclave, Model:
75 IV/082/01 01 25.06.23 24.06.28
FOW8/L; ID: 420-LVP-423-03
Operation and Cleaning of Sanamij Autoclave Model: SAR
76 IV/083/00 00 10.02.22 09.02.27
6.6.17-2V, ID No.: 420-AMN-423-04

Prepared By: Checked By: Approved By:

Md. shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

16 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Potent Drug

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

Personnel Entry/Exit and Gowning Procedure for Potent Drug

1 PT/001/03 03 25.04.19 24.04.24
Facility Manufacturing Area
Visitor Entry, Exit & Gowning Procedure in Potent Drug
2 PT/002/03 03 29.01.19 28.01.24
Facility
Change Over Clearance for The Room for Dispensing of Raw
3 PT/003/03 03 29.01.19 28.01.24
Materials
4 Dispensing of Raw Materials PT/004/03 03 29.01.19 28.01.24
5 Cleaning of Dispensing Room PT/005/03 03 29.01.19 28.01.24
6 Cleaning and Storage of Utensils Used for Dispensing PT/006/03 03 29.01.19 28.01.24
7 General Cleaning of Poroduction Floor PT/007/03 03 29.01.19 28.01.24
Jupitar Pressure Hood Gowning Procedure for Potent Drug
8 PT/008/03 03 01.02.19 31.01.24
Facility
9 General Procedure for Manufacturing of Potent Drug PT/009/03 03 29.01.19 28.01.24
10 Cleaning of Granulation Room PT/010/03 03 29.01.19 28.01.24
11 Operation of GHL High Speed Mixer Granulator PT/011/03 03 29.01.19 28.01.24
12 Cleaning of GHL High Speed Mixer Granulator PT/012/03 03 29.01.19 28.01.24
13 Operation of Rotary Tablet Press GRC-15S Machine PT/016/02 02 19.12.19 18.12.24
14 Operation and Cleaning of Cone Blender PT/017/03 03 29.01.19 28.01.24
15 Cleaning of Rotary Tablet Press GRC-15S Machine PT/018/02 02 19.12.19 18.12.24
16 Cleaning of Compression Room PT/019/03 03 29.01.19 28.01.24
17 Cleaning & Storage of Dies and Punches PT/022/03 03 29.01.19 28.01.24
18 Cleaning of Coating Room PT/023/03 03 29.01.19 28.01.24
19 Cleaning of Utensils used in Potent Drug Facilities PT/026/03 03 29.01.19 28.01.24
20 Cleaning of Cleaning Utensils PT/027/03 03 29.01.19 28.01.24
21 General Procedure For Packing PT/028/04 04 23.02.23 22.02.28
General procedure for Packaging Materials Receiving &
22 PT/029/03 03 29.01.19 28.01.24
Return
Operation & Cleaning of Hoonga HM V6 Blister Packing
23 PT/030/04 04 16.03.23 15.03.28
Machine
24 On line Checking of Blister Strips PT/031/03 03 29.01.19 28.01.24
Waste Management & Disposal Procedure for Potent Drug
25 PT/032/03 03 29.01.19 28.01.24
Facility
26 Handling of Intermediate and bulk Product PT/033/03 03 29.01.19 28.01.24
27 Material (Raw & Packaging) Handling of Potent Drug Facility PT/034/03 03 25.04.19 24.04.24
Operation, Function Check, Maintenance and Cleaning of
28 PT/038/02 02 29.01.19 28.01.24
Electronic Balance SHIMADZU, Model: BX 32KH
Entry, Exit and Gowning through Hormone Injection
29 PT/040/03 03 12.07.19 11.07.24
Manufacturing Facility

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

17 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Potent Drug

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

Entry, Exit and Gowning for Hormone Injection Packaging

30 PT/041/03 03 22.07.19 21.07.24
Area
31 Cleaning and Disinfection of Hormone Injection Facility PT/042/03 03 28.03.23 27.03.28
Operation and Cleaning of Shinva Moist Heat Sterilizer
32 PT/044/03 03 04.03.19 03.03.24
(Autoclave), Model: XG1-DTX-0.36
Operation and Cleaning of Automatic Vertical Ultrasonic Vial
33 PT/045/03 03 02.02.23 01.02.28
Washing Machine; Model: QCL-60
Operation and Cleaning of Depyrogenation Tunnel,
34 PT/046/03 03 06.02.23 05.02.28
Model : ASMR620/38
Operation and Cleaning of Shinva Moist Heat Sterilizer
35 PT/049/03 03 04.03.19 03.03.24
(Autoclave), Model: XG1-DTE-0.6B
Management of Machine Breakdown, Power Failure and
36 PT/050/03 03 11.04.23 10.04.28
Enviornmental Condition Out of Specification
37 Cleaning and Sterilization of utensils and accessories PT/051/04 04 17.05.23 16.05.28
38 Filter Management Procedure PT/052/03 03 11.04.23 10.04.28
Decartoning, Visual Inspection and Arrangement of Empty
39 PT/053/04 04 04.11.21 03.11.26
Glass Vial in SS Cassette
40 Visual Inspection of Filled Vials and Ampoules PT/054/03 03 07.05.19 06.05.24
Operation and Cleaning of filter integrity tester (Model:
41 PT/055/02 02 30.01.23 29.01.28
Sartocheck 4 Plus 26288)
Cleaning, Function Check,Operation and Calibration of
42 PT/056/03 03 02.05.23 01.05.28
Weighing Balance
43 Garments Management Procedure PT/058/03 03 13.05.23 12.05.28
44 Personnel Hygiene in Hormone Facility PT/060/03 03 11.04.23 10.04.28
45 Cleaning and Operation of Dynamic Pass Box PT/061/05 05 17.05.23 16.05.28
46 Management of Primary Packing Material PT/063/03 03 13.05.23 12.05.28
47 Handling and Storage of Filled Vials and Ampoules PT/064/03 03 13.05.23 12.05.28
48 Cleaning and Operation of Laminar Air Flow Unit PT/065/03 03 09.05.23 08.05.28
49 Receiving of Packaging Materials in Hormone Injection Facility PT/066/03 03 01.03.23 29.02.28
50 Preparation and Sterilization of Disinfectant Solution PT/069/03 03 13.03.21 12.03.26
Cleaning ,Sterilization and Operation of Ritai 100 Liter
51 PT/073/03 03 02.05.23 01.05.28
Manufacturing Vessel, Model: 10P0860
Cleaning ,Sterilization and Operation of Ritai 50 Liter
52 Manufacturing Vessel (Model: 10P0859) and Storage Vessel PT/074/03 03 02.05.23 01.05.28
(Model: 10P862)

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

18 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Potent Drug

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

Cleaning ,Sterilization and Operation of Ritai 30 Liter

53 PT/075/03 03 15.05.23 14.05.28
Manufacturing Vessel, Model: RT-30L
54 Operation and Cleaning of Oven, Model: JSON-100 PT/077/03 03 16.01.23 15.01.28
55 Disposal of Rejected Hormone Injections (Vials/Ampoules) PT/078/02 02 25.09.18 24.09.23
56 Operation and Cleaning of Sterile Dress Cabinet PT/079/02 02 07.02.23 06.02.28
57 Reconciliation of Packaging Materials PT/082/02 02 17.02.23 16.02.28
Operation, Cleaning and Serilization Procedure of Tofflon
58 PT/083/02 02 23.02.23 22.02.28
Lyophilizer; Model : Lyo-2
59 Cleaning & Operation of Double Cone Blender (850 L) PT/088/02 02 16.05.23 15.05.28
Operation, Function check, Maintenance and
60 Cleaning of Electronic Weighing Balance Jadever (Model JWI- PT/089/01 01 21.07.19 20.07.24
700W)
Operation, Function Check, Weighing, Maintenance and
61 PT/090/01 01 31.03.20 30.03.25
Cleaning of Electronic Balance Shimadzu (Model TX223L)
Operation and Cleaning of Rota Ampoule Filling and Sealing
62 PT/091/01 01 04.04.20 03.04.25
Machine (R921 MA/20)
Storage and Handling of Cold Chain API and Intermediate
63 PT/092/01 01 08.07.20 07.07.25
Lyophilized Hormone Injections
Operation of Pharma Flex Pharma Flex Tablet De-Duster
64 PT/094/01 01 23.05.20 22.05.25
with Metal Detector
Cleaning of Pharma Flex Tablet De-Duster with Metal
65 PT/095/01 01 23.05.20 22.05.25
Detector
66 Operation of Fette Compacting 3200i Machine PT/096/01 01 23.05.20 22.05.25
67 Cleaning of Fette Compacting 3200i Machine PT/097/01 01 23.05.20 22.05.25
Operation of Sejong Automatic Coating Machine
68 PT/098/01 01 29.05.20 28.05.25
SFC-170FSH
69 Cleaning of Sejong Coating Machine SFC-170FSH PT/099/01 01 29.05.20 28.05.25
70 Operation of NR Automatic Film Coating Machine FC-29 PT/100/01 01 25.07.20 24.07.25
71 Cleaning of NR Automatic Film Coating Machine PT/101/01 01 25.07.20 24.07.25
Operation, Function Check, Weighing, Maintenance and
72 PT/102/01 01 20.08.20 19.08.25
Cleaning of Electronic Balance Shimadzu (Model TX323L)
73 Operation and Cleaning of Sifter (Gansons) Machine PT/103/01 01 30.11.20 29.11.25
74 Operation and Cleaning of Multi Mill PT/104/01 01 30.11.20 29.11.25
75 Operation and Cleaning of Drum Blender PT/105/01 01 30.11.20 29.11.25
Operation, Function Check, Weighing, Maintenance and
76 Cleaning of Electronic Balance NAGATA PT/106/01 01 30.11.20 29.11.25
(Model KW-303-RL15)
Personnel Entry/Exit and Gowning Procedure for Oral Solid
77 PT/107/01 01 11.04.23 10.04.28
Hormone Facility Packing Area

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

19 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Potent Drug

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

78 Cleaning and Management of Mesh used in Hormone Solid FaciPT/109/02 02 19.01.23 18.01.28
79 Cleaning, Sterilization and Operation of Pressure Vessels PT/110/01 01 24.05.23 23.05.28
Operation and Cleaning of Pouch Sealing Machine,
80 PT/111/00 00 01.11.18 31.10.23
Model: BF 900
81 Operation and Cleaning of Uhlmann Blister Packing Machine PT/112/00 00 25.03.19 24.03.24
Operation and Cleaning of ROTA Vial Filling and Stoppering
82 PT/114/00 00 09.09.19 08.09.24
Machine, Model: FLL201/G
Operation and Cleaning of ROTA Vial Capping & Crimping
83 PT/115/00 00 09.09.19 08.09.24
Machine, Model: FLR201/B
Operation and Cleaning of Laminar Air Flow (LAF) Unit of
84 PT/116/00 00 09.09.19 08.09.24
Rota Vial Filling & Capping Machine
Cleaning, Sterilization and Operation of 150 Lit. Manufacturing
85 PT/117/00 00 30.01.20 29.01.25
& Storage Vessels
86 File Numbering Procedure in Hormone Injection Facility PT/118/00 00 16.03.21 15.03.26
Operation, Calibration, Function Check and Cleaning of
87 PT/120/00 00 21.03.21 20.03.26
Analytical Balance Sartorius [Model CP323 S]
88 Operation and Cleaning of Biosafety Cabinet PT/121/00 00 11.05.21 10.05.26
Operation and Cleaning of Sunjin Automatic Ampoule/ Vial
89 PT/122/00 00 04.11.21 03.11.26
Labeling Machine
Operation and Cleaning of Hologram Sticker Labelling
90 PT/123/00 00 13.04.22 12.04.27
Machine (Model : AL320)
91 Operation and Cleaning of Packing Conveyar Belt PT/124/00 00 06.02.23 05.02.28
92 Cleaning and Operation of Ink Jet Printer (VIDEOJET) PT/125/00 00 15.05.23 14.05.28
93 Collection and Storage Procedure of Purified Water PT/126/00 00 30.05.23 29.05.28

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

20 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Oral Solid

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

Entry & Exit procedure at Oral Solid Manufacturing Area for

1 SL/001/06 06 16.03.23 15.03.28
Non-Management Staff
Entry & Exit procedure at Oral Solid Manufacturing Area for
2 SL/003/06 06 16.03.23 15.03.28
Management Staff
Cleaning procedure of manufacturing and primary packaging
3 SL/004/06 06 16.03.23 15.03.28
area of Granulation Area
4 Operation of Sejong MRC 37 D Compression Machine SL/006/05 05 01.10.19 30.09.24
Operation of Automatic Tablet Counting & Filling Machine
5 SL/007/05 05 14.12.20 13.12.25
JB-32A
6 Operation of Automatic Cap Sealing Machine JC-SP SL/008/05 05 14.12.20 13.12.25
7 Cleaning of Sejong Compression Machine MRC 37 D SL/009/05 05 11.10.19 10.10.24
8 Operation of Super Mixer Granulator (SMG) SL/012/05 05 25.10.18 24.10.23
9 Cleaning of Super Mixer Granulator (SMG) SL/013/06 06 16.03.23 15.03.28
Operation of Sejong Automatic Coating Machine SFC-130
10 SL/022/04 04 05.11.18 04.11.23
FSN
11 Operation and Cleaning of Drum Blender SL/027/05 05 16.03.23 15.03.28
12 Operation and Cleaning of Cosmec Blender SL/028/04 04 10.12.18 09.12.23
Operation and cleaning of Noack-921 Blister Machine
13 SL/029/05 05 16.03.23 15.03.28
(Model:921)
14 Cleaning of Sejong Coating Machine SFC-130 FSN SL/030/04 04 22.07.19 21.07.24
15 Operation of Pam- Glatt Fluid Bed Processor FBE-250 SL/031/04 04 25.10.18 24.10.23
16 Operation of NR High Speed Mixer Granulator (M-65) SL/032/04 04 02.09.16 01.09.24
17 Operation of Fluid Bed Drye (NR) Machine SL/034/04 04 30.09.19 29.09.24
18 Cleaning of NR Fluid Bed Dryer (FB-65) SL/035/04 04 04.04.19 03.04.24
19 Operation of Zanasi 40 F Encapsulation Machine SL/037/04 04 20.10.19 19.10.24
20 Cleaning of Zanasi 40 F Encapsulation Machine SL/038/04 04 20.10.19 19.10.24
Cleaning of Automatic Tablet Counting & Filling Machine
21 SL/044/04 04 02.10.19 01.10.24
JB-32A
22 Cleaning and Storage of Fluid Bed Dryer Filter Bag SL/046/04 04 22.11.18 21.11.23
23 Cleaning, Storage and Issue of Dies and Punches SL/048/05 05 19.04.23 18.04.28
24 Operation & Cleaning of Gansons Comminuting Mill SL/050/03 03 07.12.18 06.12.23
25 Handling of FBD Filter Bag SL/052/05 05 19.04.22 18.04.27
26 Cleaning of Utensils in Oral Solid Manufacturing Area SL/053/04 04 12.02.20 11.02.25
27 Cleanliness and Management of Wash Bay SL/059/04 04 21.06.23 20.06.28
General Procedure of Manufacturing at Oral Solid
28 SL/064/04 04 01.06.20 31.05.25
Manufacturing Area
29 General Procedure for Packaging SL/065/03 03 23.09.19 22.09.24
Operation and Cleaning of ALL FILL Semi Auto Powder Filling
30 SL/070/03 03 01.04.19 31.03.24
Machine

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

21 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Oral Solid

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

Operation and Cleaning of Semi Automatic Cap Sealing

31 SL/071/03 03 01.04.19 31.03.24
Machine
32 Cleaning of Single Rotary Tableting Machine Clit CPMD3-16 SL/073/03 03 07.12.18 06.12.23
33 Operation and Cleaning of Metal Detector Machine SL/075/03 03 03.06.19 02.06.24
34 Die-Punch Checking and Polishing Procedure SL/076/03 03 03.06.19 02.06.24
35 Application of Cleaning and Disinfectant Agent SL/077/03 03 03.06.19 02.06.24
36 Operation & Cleaning of Sifter (Gansons) Machine SL/078/03 03 30.09.18 29.09.23
37 Cleaning of Mesh SL/079/03 03 07.06.19 06.06.24
38 Operation and Cleaning of Image Jet Printing Machine SL/080/03 03 01.10.19 30.09.24
39 Operation and Cleaning of KK & KK Auto Labeling Machine SL/081/03 03 01.10.19 30.09.24
Operation and Cleaning of Capsule and Tablet Inspection
40 SL/082/03 03 07.06.19 06.06.24
Machine
41 Manual Cleaning and Storage of Fluid Bed Dryer Filter Bag SL/083/02 02 02.10.18 01.10.23
42 Cleaning of Vacuum Cleaner SL/084/03 03 07.06.19 06.06.24
43 Operation and Cleaning of Documents Pass Box SL/085/03 03 04.09.19 03.09.24
Waste Management and Disposal of Oral Solid Manufacturing
44 SL/086/03 03 01.10.19 30.09.24
and Packaging Area
45 Operation and Cleaning of Materials Pass Box SL/090/03 03 04.09.19 03.09.24
46 Maintenance and Cleaning of UV Insect Killer SL/091/04 04 16.03.23 15.03.28
Personnel Entry/Exit and Gowning for Secondary Packaging
47 SL/092/03 03 06.02.19 05.02.24
Area For Employee
48 Cleaning and Maintenance of Empty Drum SL/093/03 03 01.10.19 30.09.24
16.01.20
49 On line Weighing of Finished Pack SL/094/03 03 15.01.25
18.01.14
50 Operation of KK & KK (KK-570) Carton Printing Machine SL/095/03 03 01.10.19 30.09.24
51 Operation of Sejong Compression Machine MRC 61D SL/096/04 04 18.05.20 17.05.25
52 Cleaning of Sejong Compression Machine MRC 61D SL/097/04 04 18.05.20 17.05.25
Operation Function Check, Weighing, Maintenance and
53 Cleaning of Electronic Balance DINI ARGEO SL/106/02 02 17.04.19 16.04.24
(Model PBE 150)
54 Operation and Cleaning of Conveyor Belt SL/111/03 03 14.11.20 13.11.25
55 General Cleaning of Primary Packaging Area SL/113/02 02 03.09.19 02.09.24
56 Operation & Cleaning of Multi Mill SL/114/02 02 03.09.19 02.09.24
57 Operation & Cleaning of Cone Mill SL/115/02 02 03.09.19 02.09.24
58 Operation and Cleaning of Automatic Capsule Loader SL/116/02 02 03.09.19 02.09.24
Operation and Cleaning of Hoong-A Packing Machine,
59 Oeration and Cleaning of Pharma Chem Manual SL/118/02 02 01.01.19 31.12.23
(Model : Ministar V6)
Encapsulation Machine (Model SS-316)
60 SL/119/02 02 20.08.19 19.08.24

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

22 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Oral Solid

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

Operation Function Check Weighing Maintenance and

61 SL/120/02 02 17.04.19 16.04.24
Cleaning of Electronic Balance NAGATA TW- 702- RL10
62 Operation of Cadmach CMD4-20 Compression Machine SL/121/02 02 15.12.19 14.12.24
63 Cleaning of Cadmach CMD4-20 Compression Machine SL/122/02 02 15.12.19 14.12.24
Operation of Sejong Automatic Coating Machine
64 SL/123/02 02 13.02.20 12.02.25
SFC-150 FSN
65 Cleaning of Sejong Coating Machine SFC-150 FSN SL/124/02 02 13.02.20 12.02.25
Operation, Function check, weighing, Maintenance and
66 SL/125/02 02 17.04.19 16.04.24
Cleaning of Electronic Balance Shimadzu (Model TX323L)
67 Cleaning and Operation of Alliance Fluid Bed Dryer SL/132/02 02 20.06.23 19.06.28
Bottle Drying and Transfer Procedure of Powder for
68 SL/134/01 01 06.02.19 05.02.24
Suspension
69 Cleaning of NR High Speed Mixer Granulator (M-65) SL/135/01 01 19.07.20 18.07.25
70 Operation and Cleaning of Minitouch Printing Machine SL/136/01 01 20.11.20 19.11.25
71 Cleaning and Operation of Pharmalab Auto Labeling Machine SL/137/01 01 31.05.23 30.05.28
72 Operation and Cleaning of Tablet de-duster SL/138/00 00 07.02.19 06.02.24
Personnel Entry/Exit and Gowning for Secondary Packaging
73 SL/139/00 00 07.02.19 06.02.24
Area For Management Staff
74 Operation and Cleaning of Hoonga Auto Cartoning Machine SL/142/00 00 15.07.20 14.07.25
Operation and Cleaning of Harro Hofliger Capsule Filling
75 SL/143/00 00 06.03.21 05.03.26
Machione
Operation and Cleaning of Hologram Sticker Labeling
76 SL/144/00 00 16.03.21 15.03.26
Machine (Model: AL320)
Operation and Cleaning of Glatt High Shear Granulator &
77 Fluid Bed Processor SL/145/00 00 30.12.21 29.12.26
78 Operation and Cleaning of Uhlmann Blister Packing Machine SL/146/00 00 03.07.21 02.07.26
79 Operation and Cleaning of Uhlmann Cartoner Machine SL/147/00 00 03.07.21 02.07.26
Operation and Cleaning of Monoblock Rotary Liquid Filling
80 SL/148/00 00 30.12.21 29.12.26
and Capping Machine
Operation and Cleaning of Romaco Kilian K 720 Compression
81 SL/149/00 00 30.12.21 29.12.26
Machine
Glatt PanDics
82 Operation and Cleaning of Portable Coater
typeGCSi 700 mixer
Agitator SL/150/00 00 16.06.22 15.06.27
83 syatem SL/151/00 00 16.03.23 15.03.28

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

23 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Sachet

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

1 General Procedure for Manufacturing of Sachet Facility SH/001/04 04 15.12.20 14.12.25

2 Cleaning of Manufacturing Area SH/002/04 04 15.12.20 14.12.25
3 Operation and Cleaning of Tumbling Mixer SH/003/03 03 11.03.19 10.03.24
4 Operation of SOLPAC Automatic Sachet Filling Machine SH/006/03 03 23.02.20 22.02.25
5 Cleaning of SOLPAC Automatic Sachet Filling Machine SH/007/03 03 10.03.20 09.03.25
6 On line Cheking of Sachet SH/008/03 03 22.07.19 21.07.24
7 General Procedure for Packaging of Sachet SH/009/05 05 18.01.23 17.01.28
Operation, Function check, Maintenance and
8 SH/012/02 02 22.03.20 21.03.25
Cleaning of TAWANKA Balance (Model TWP)
Operation of SOLPAC Automatic (Six Cutter) Sachet Filling
9 SH/014/02 02 23.03.20 22.03.25
Machine
Cleaning of SOLPAC Automatic (Six Cutter) Sachet Filling
10 SH/015/02 02 14.08.20 13.08.25
Machine
11 Cleaning of Sieve SH/016/01 01 14.02.19 13.02.24
12 Operation & Cleaning of Shifter (Gansons) Machine SH/017/01 01 14.02.19 13.02.24
Operation and Cleaning of KK & KK (KK-570) Carton Printing
13 SH/018/00 00 03.03.19 02.03.24
Machine
14 Operation and Cleaning of Conveyor Belt SH/019/00 00 19.09.19 18.09.24
15 Control and Issuance Of Log books SH/020/00 00 10.10.19 09.10.24
16 Waste Management of Sachet Facility SH/021/00 00 30.10.19 29.10.24
Monitoring of Temperature and Relative Humidity in Sachet
17 SH/022/00 00 08.04.20 07.04.25
Facility
18 Entry, Exit Procedure at ORS Manufacturing Area SH/023/01 01 31.05.23 30.05.28
19 Receive and Return of Packing Materials SH/024/00 00 13.12.20 12.12.25
20 Cleaning of Secondary Packing Area SH/025/00 00 15.12.20 14.12.25
21 Operation and Cleaning of BIN Blender-1000L SH/026/01 01 31.05.21 30.05.26
22 Operation, Cleaning and Maintenance of Dispensing Booth SH/027/00 00 03.01.21 02.01.26
23 Cleaning and Storage of Utensils SH/028/00 00 03.01.21 02.01.26
Operation, Function Check, Maintenance and
24 SH/029/00 00 03.01.21 02.01.26
Cleaning of Sartorius [Model: Minebea Intec] Balance
Operation and Cleaning of Sanko Automatic Sachet Filling
25 Machine SH/030/00 00 21.03.21 20.03.26
26 Operation and Cleaning of CVC Printing Machine SH/031/00 00 21.06.21 20.06.26
Operation, Function Check, Weighing, Maintenance and
27 SH/032/00 00 02.09.21 01.09.26
Cleaning of Electronic Balance Shimadzu [Model TX423L]
Operation, Function Check, Weighing, Maintenance and
28 SH/033/00 00 09.09.21 08.09.26
Cleaning of Electronic Balance Shimadzu [Model BX32KH]
29 Operation and Cleaning of Dynamic Pass Box SH/034/00 00 31.05.22 30.05.27

Prepared By: Checked By: Approved By:

POPULAR PHARMACEUTICALS LTD.

SOP List

Sterile Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

1 Entry/Exit Procedure in Sterile Facility ST/001/07 07 06.03.23 05.03.28

Action Taken in Case of Power/Air Condition Failure During
2 ST/003/04 04 05.10.19 04.10.24
Aseptic Filling
Operation and Cleaning of ROTA Ampoule Filling Machine
3 ST/004/04 04 05.10.19 04.10.24
(R921 MA/20)
4 Preparation of Filtration Set and Sterilization ST/006/05 05 31.10.20 30.10.25
Washinh and Sterilization of Dress used for Class C and
5 ST/007/05 05 17.11.20 16.11.25
Class B Area
Preparation & Usage of Cleaning and Disinfectant of Different
6 ST/008/05 05 06.02.23 05.02.28
Areas of Sterile Facility
7 Disposal of Rejected Filled Ampoules ST/009/04 04 05.10.19 04.10.24
Cleaning of Process/Manufacturing related Equipments and
8 ST/012/04 04 07.02.19 06.02.24
Contact Parts of Filling and Sealing Machine
9 Din Ampoule arrangement in the S.S Cassettes ST/014/04 04 02.08.20 01.08.25
10 Visual Inspection of Filled Ampoules ST/015/04 04 06.02.19 05.02.24
Operation and Cleaning of Celester Autoclave Model :
11 ST/016/04 04 27.07.20 26.07.25
SM 600+GVP 150I
12 Receiving of Pre-sterilized Bottle, Cap and Nozzle ST/017/01 01 07.10.19 06.10.24
13 Operation of WFI Control Panel for Collection of WFI ST/018/03 03 05.10.19 04.10.24
Operation and Cleaning of Labelling Machine, Model: KK-
14 ST/019/03 03 16.01.23 15.01.28
906B
15 Operation and Cleaning of Dynamic Pass Box ST/020/03 03 16.01.23 15.01.28
16 Integrity Test for Air Vent Filter, Model No. (MIDISART 2000) ST/021/03 03 30.01.23 29.01.28
Operation and Cleaning of Filter Integrity Tester, Model:
17 ST/023/04 04 14.03.23 13.03.28
Sartocheck 4 Plus 26288
Receiving of Raw Material from Warehouse and Store in
18 ST/025/03 03 02.01.20 01.01.25
Plastic Container
19 Entry/Exit procedure of powder for injection facility ST/027/03 03 03.02.23 02.02.28
Operation and Cleaning of Vial Washing Machine, Ambica
20 ST/030/04 04 09.08.20 08.08.25
Model : ARVW-120

Operation and Cleaning of Automatic Injectable Powder Filling

21 ST/031/04 04 10.08.20 09.08.25
and Rubber Stoppering Machine, Ambica Model : AHPF-120

Operation and Cleaning of Automatic Cap Sealing Machine,

22 ST/032/04 04 21.08.20 20.08.25
Ambica Model : AHCS-150
Operation and Cleaning of Electrolab Vial Filling Machine,
23 ST/033/03 03 27.11.20 26.11.25
Model : PP202LCS

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Ahahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

25 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Sterile Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

Personnel entry/exit and Gowning through Change Room for

24 ST/034/04 04 16.12.20 15.12.25
Dialysis Solution Unit
Set Up and Operation of Dialysis Solution Container Cleaning
25 ST/035/04 04 16.12.20 15.12.25
Machine
Assembling, Dismantling and Cleaning of Pharmalab
26 ST/037/04 04 16.12.20 15.12.25
Container Filling Machine
27 Manufacturing,Filtration and Filling of Dialysis Solution ST/038/05 05 24.04.20 23.04.25
28 Preparation of 70% Filtered IPA ST/039/04 04 29.10.20 28.10.25
Operation and Cleaning of Pre-filled Syringe filling and
29 ST/040/03 03 09.01.23 08.01.28
Stoppering Machine Model: PFS-05/A-5-6001
Operation and Cleaning of Rotary Vial Washing Machine,
30 ST/041/03 03 07.07.19 06.07.24
Model : ECRW-I8A
Operation and Cleaning of Sanamij Autoclave Model: SAR
31 ST/044/03 03 07.07.19 06.07.24
6.6.6-2V
32 CIP and Sterilization of Insulin Manufacturing Vessels ST/045/03 03 07.07.19 06.07.24
33 Visual Inspection of Filled Vials ST/046/04 04 06.02.19 05.02.24
Operation and Cleaning of Chutian Vial Filling and Stoppering
34 ST/047/03 03 28.02.19 27.02.24
Machine Model: DGS4D
Operation and Cleaning of Chutian Vial Cap sealing Machine,
35 ST/048/03 03 16.01.23 15.01.28
Model:ZG300C
CIP, SIP and Operation of Yenchen 100 Liter Manufacturing
36 ST/052/03 03 05.10.19 04.10.24
Vessel [Model No. YC-JMT-125]
37 General Housekeeping of Packaging Area ST/053/03 03 16.03.20 15.03.25
38 General Packaging in Sterile Area ST/055/03 03 01.01.23 31.12.27
39 Receiving of Cold Chain Material from Warehouse ST/056/04 04 07.05.23 06.05.28
40 General Procedure for Packing of Dialysis Solution ST/057/04 04 16.12.20 15.12.25
41 General Procedure for Manufacturing of Dialysis Solution ST/058/04 04 16.12.20 15.12.25
42 General Cleaning procedure of Dialysis Facility ST/059/05 05 25.06.23 24.06.28
43 Operation of Buchon WIDER SIII Blister Machine ST/066/02 02 26.08.20 25.08.25
Setting,Operation and Cleaning of Sticker Labeling Machine,
44 ST/068/02 02 18.04.23 17.04.28
Model : TB-200
Operation and Cleaning of ROTA Ampoule Filling Machine
45 ST/070/01 01 12.03.19 11.03.24
(R960/MA)
Operation and Cleaning of Image Printing Machine
46 ST/071/01 01 13.10.18 12.10.23
(Model : 58 MASTER)
47 Operation and Cleaning of Flexi Filler Machine ST/072/01 01 13.10.18 12.10.23
Operation and Cleaning of Induction Cap Sealing Machine,
48 ST/074/01 01 24.05.19 23.05.24
Model: SIGMA I ACE

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Ahahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

26 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Sterile Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

Operation, Function Check, Maintenance and Cleaning of

49 ST/075/01 01 14.07.19 13.07.24
Dispensing Balance Shimadzu [Model BX32KS]
Operation and Cleaning of Horiozontal Ampoule Labeller
50 ST/076/01 01 25.09.19 24.09.24
(Model: CVC 350U)
51 Cleaning of Lyophilize Machine, Model: Lyo-10 ST/077/01 01 09.10.19 08.10.24
52 Sterilization of Lyophilize Machine, Model: Lyo-10 ST/078/01 01 09.10.19 08.10.24
53 Operation of Lyophilize Machine, Model: Lyo-10 ST/079/01 01 09.10.19 08.10.24
54 De-Icing of Lyophilize Machine, Model: Lyo-10 ST/080/01 01 09.10.19 08.10.24
Operation, Calibration, Function Check, Cleaning and
55 Maintenance of Analytical Balance Radwag ST/081/01 01 19.10.19 18.10.24
[Model AS 310.R2]
Operation and Cleaning of Dry Heat Sterilizer
56 ST/082/01 01 09.12.19 08.12.24
Model: XRSHX-IIIJ
Operation, Calibration and Maintenance of Mettler Toledo pH
57 ST/083/02 02 31.07.23 30.07.26
Meter [Model : Seven Compact S210]
Integrity Test for Cartridge Filter by Palltronic Flowstar
58 ST/084/01 01 26.02.23 25.02.28
IV FFS04S
Operation, Function Check,Maintenance and Cleaning of
59 ST/085/00 00 04.01.19 03.01.24
Balance SHIMADZU [Model TXB620AL]
Operation, Function Check,Maintenance and Cleaning of
60 ST/086/00 00 22.01.19 21.01.24
Balance SHIMADZU[Model :BX12KH]
61 Qualification of Visual Inspector ST/088/00 00 09.04.19 08.04.24
Operation and Cleaning of Fedegari Autoclave [ Model:
62 ST/089/00 00 19.05.19 18.05.24
XFOAF5/Q04E]
Operation and Cleaning of Multi-Function Plastic Flim Sealing
63 ST/090/00 00 06.08.19 05.08.24
Machine [Model No. BF-900]
Operation and Cleaning of 60 Liter FD Manufacturing Vessel
64 ST/091/00 00 06.08.19 05.08.24
[Model No. ES-1400]
65 Operation and Cleaning of IKA Stirrer [Model No. RW 28 B] ST/092/00 00 21.08.19 20.08.24
Operation and Cleaning of CVC Imprinting Machine
66 ST/093/00 00 21.08.19 20.08.24
[Model No. 584]
67 Operation and Cleaning of Shrink Wrapping Machine ST/094/00 00 22.08.19 21.08.24
68 Personnel Gowning Qualification ST/095/00 00 22.08.19 21.08.24
Entry, Exit and Gowning for Sterile Packing Area Extension
69 ST/096/00 00 12.09.19 11.09.24
(2nd Floor)
Operation and Cleaning of Hologram Sticker Labeling
70 ST/097/01 01 25.12.22 24.12.27
Machine (Model: AL320)
Operation and Cleaning of Eye Drop Filling, Plugging and
71 ST/098/00 00 15.11.19 14.11.24
Over Capping Machine, [Model:FLL201/TS]

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Ahahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

27 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Sterile Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

Operation and Cleaning of Automatic Ampoule and Vial

72 ST/099/00 00 16.05.20 15.05.25
Inspection Machine, [Model: NIKE]
Operation of Online Air Borne Particle Counter Machine
73 ST/100/01 01 19.12.20 18.12.25
(Model: FacilityPro 3010)
Operation and Cleaning of Depyrogenation Tunnel, Model:
74 ST/101/00 00 13.08.20 12.08.25
FTV20/01-01
Operation, Function Check,Maintenance and Cleaning of
75 ST/102/00 00 23.01.21 22.01.26
Weighing Balance Baxtran[Model :DSN30]
76 Operation and Cleaning of Imaje Printer (Model: 9030) ST/103/00 00 15.03.21 14.03.26
CIP and SIP of Sterinox Systems 400 Liter Manufacturing
77 ST/104/00 00 27.03.21 26.03.26
Vessel [Model No. SS-SMV-400]
Operation, Function Check, Maintenance and Cleaning of
78 ST/105/00 00 02.08.21 01.08.26
Balance SHIMADZU [Model TX423L]
Operation and Cleaning of Hoonga Automatic Blister Packing
79 ST/106/00 00 13.11.22 12.11.27
Machine, (Model: HM AV)
80 Waste Management in Sterile Facility ST/107/00 00 19.01.23 18.01.28
Operation and Cleaning of Packaging Conveyor Belt in sterile
81 ST/108/00 00 11.02.23 10.02.28
Facility
Operation and Cleaning Procedure of Fogger Machine,Model
82 ST/109/00 00 14.03.23 13.03.28
3018 (SFD)
83 Operation and Cleaning of VIDEOJECT Printer (Model:1880) ST/110/00 00 16.05.23 15.05.28
Operation and Cleaning Procedure of Drying Oven (Model
84 ST/111/00 00 10.05.23 09.05.28
No.: FED 720)

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Ahahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

28 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Animal Health

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

1 Control of Manufacturing of Animal Health Products AH/001/01 01 30.09.19 29.09.24

2 Operation & Cleaning of Drum Blender AH/002/01 01 30.09.19 29.09.24
3 General Cleaning and Maintenance of Animal Health Area AH/005/01 01 03.10.19 02.10.24
4 Personnel Entry, Exit and Gowning in Manufacturing Area AH/007/02 02 23.01.23 22.01.28
5 Personnel Entry, Exit and Gowning in Packaging Area AH/008/02 02 23.01.23 22.01.28
6 Operation and Cleaning of Sifter (Gansons) Machine AH/009/01 01 06.10.19 05.10.24
7 Cleaning of Sieve AH/010/01 01 06.10.19 05.10.24
8 Operation & Cleaning of Multi Mill AH/011/01 01 06.10.19 05.10.24
9 Operation of JAGUAR Compression Machine 12 Station AH/012/01 01 06.10.19 05.10.24
10 General Procedure for Packaging AH/014/02 02 04.01.23 03.01.28
11 Operation and Cleaning of Mark Liquid Filling Machine AH/015/01 01 06.10.19 05.10.24
12 Cleaning of Blending Area AH/016/01 01 06.10.19 05.10.24
Waste Management and Disposal of Animal Health
13 AH/017/01 01 06.10.19 05.10.24
Manufacturing and Packaging Area
Operation and Cleaning of JOSTON Steam Jacketed
14 AH/018/00 00 01.09.21 31.08.26
Manufaturing Vessel, 1500 L
15 Operation and Cleaning of JOSTON Storage Vessel, 1500 L AH/019/00 00 01.09.21 31.08.26
16 Operation and Cleaning of JOSTON Steam Jacketed ManufaturingAH/020/00 00 01.09.21 31.08.26
Operation and Cleaning of Portable Homogenizer (Silverson)
17 AH/021/00 00 14.09.21 13.09.26
Agitator Mixer
18 Operation and Cleaning of Portable Disc Type Agitator Mixer AH/022/00 00 14.09.21 13.09.26
19 Operation and Cleaning of Double Cone Blender AH/023/00 00 05.10.21 04.10.26
20 Operation and Cleaning of Lung Wei Bottle Washing Machine AH/024/00 00 08.11.21 07.11.26
21 Operation and Cleaning of Lung Wei Liquid Filling Machine AH/025/00 00 08.11.21 07.11.26
22 Operation and Cleaning of Lung Wei Capping Machine AH/026/00 00 08.11.21 07.11.26
Operation and Cleaning of Fluidpack Tablet Compression
23 AH/027/00 00 09.03.22 08.03.27
Machine
24 Operation and Cleaning of Dispensing Booth AH/028/00 00 20.04.22 19.04.27
Operation, Function Check, Weighing, Maintenance and
25 AH/029/00 00 28.04.22 27.04.27
Cleaning of Electronic Balance Shimadzu [Model TX423L]
Operation, Function Check, Weighing, Maintenance and
26 Cleaning of Electronic Balance Minebea intec combics 3 [Model AH/030/00 00 08.05.22 07.05.27
CAW3P1-150GF-I]

27 Operation and Cleaning of Weighing Balance DINI ARGEO AH/031/00 00 07.08.22 06.08.27
[WET - 30 - 1/ DFWL - 1]
Operation and Cleaning Procedure of Sunny Automatic
28 AH/032/00 00 12.02.23 11.02.28
Granules Filling Machine (Model: SDXD 15)
Operation and Cleaning Procedure of GANSONS High Shear
29 AH/033/00 00 23.02.23 22.02.28
Mixer Granulator (Model: HSMG 150)
Operation and Cleaning Procedure of GANSONS Fluidized Bed
30 AH/034/00 00 23.02.23 22.02.28
Processor (Model: GFBP 150)

Prepared By: Checked By: Approved By:

POPULAR PHARMACEUTICALS LTD.

SOP List

Engineering Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

1 Management of Plant Maintenance Activities EN/001/07 07 17.11.22 16.11.27

2 HVAC System Operation and Maintenance EN/003/05 05 29.06.20 28.06.25
3 HVAC Filter Monitoring, Changing and Cleaning EN/004/07 07 28.05.23 27.05.28
4 Operation and Maintenance of Air Compressors EN/007/06 06 31.12.22 30.12.27
Operation & Maintenance of Purified Water Plant for
5 EN/008/06 06 30.12.19 29.12.24
Solid/Liquid/Sterile
Operation and Maintenance Procedure of Water for Injection
6 EN/009/05 05 29.02.20 28.02.25
Plant (Sterile & Cephalosporin)
7 Calibration EN/010/07 07 30.12.19 29.12.24
8 Calibration of Temperature Sensor EN/011/05 05 25.08.18 24.08.23
9 Calibration of Pressure Gauge/Transmitter EN/012/05 05 21.08.18 20.08.23
10 Operation and Maintenance of Substation EN/013/04 04 02.12.18 01.12.23
11 Operation & Maintenance of Electric Distribution Panel EN/014/04 04 27.12.18 26.12.23
12 Calibration of Manufacturing Vessels Weight Indicator EN/015/04 04 19.07.18 18.07.23
13 Procedure of Rotation (RPM) Measurement EN/016/04 04 15.09.22 14.09.27
Principle of Calibration for Water Treatment Plant
14 EN/017/03 03 17.05.19 16.05.24
(PW & WFI)
15 Operation & Maintenance Procedure of Steam Boiler EN/018/05 05 11.01.23 10.01.28
16 Calibration of Moisture Analyzer EN/019/05 05 12.11.20 11.11.25
17 Operation and Maintenance Procedure of Potable Water System EN/020/04 04 08.09.18 07.09.23
18 Waste Management EN/022/04 4 29.08.20 28.08.25
19 Operation and Maintenance of Workshop Equipment & Tools EN/023/05 05 29.12.19 28.12.24
Operation and Maintenance Procedure of Effluent Treatment
20 EN/024/04 04 06.03.21 05.03.26
Plant
21 Plant Equipment Identification Numbering System EN/027/03 03 28.11.20 27.11.25
22 Calibration of Pack Integrity Tester/Leak Test Apparatus EN/030/04 04 28.06.20 27.06.25
Preventive Maintenance of Vial Washing Machine,
23 EN/031/04 04 30.08.19 29.08.24
(W600-8)
24 Preventive Maintenance of Depyrogenation Tunnel (T600/H1C1) EN/032/04 04 17.05.19 16.05.24
Preventive Maintenance of Powder Filling and Stoppering Unit
25 (Micro 9) EN/033/04 04 30.08.19 29.08.24
Preventive Maintenance of Vial Cap Sealing Unit (CSP10)
26 EN/034/04 04 17.05.19 16.05.24
Preventive Maintenance of Auto Capsule Filling Machine
27 EN/036/04 04 17.05.19 16.05.24
(SF-40N)
Preventive Maintenance of Automatic Powder Filling Machine(JC-
28 EN/037/04 04 17.05.19 16.05.24
PF-2)

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

30 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Engineering Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date
29 Preventive Maintenance of Blister Packing Machine (Ministar-V6) EN/038/04 04 17.05.19 16.05.24
Preventive Maintenance of Automatic Ampoule Filling & Sealing
30 EN/039/04 04 30.12.19 29.12.24
Machine (R921/MA)
31 Preventive Maintenance of Manufacturing Vessel 100 Liter EN/041/04 04 30.12.19 29.12.24
32 Preventive Maintenance of IBC Blender (MB G20-10BC) EN/043/04 04 30.08.19 29.08.24
33 Preventive Maintenance of Bottle Labeling Machine (Glue) EN/044/04 04 30.08.19 29.08.24

34 Preventive Maintenance of Automatic Cap Sealing Machine(FD) EN/045/04 04 30.08.19 29.08.24

35 Calibration of Friability Tester EN/046/04 04 12.03.19 11.03.24
Preventive Maintenance of Autoclave
36 EN/047/04 04 30.12.19 29.12.24
(Sterimega 600)
37 Preventive Maintenance of Manufacturing Vessel (500 L) EN/048/04 04 20.05.19 19.05.24

38 Preventive Maintenance of Manufacturing Vessel (1500 L) EN/049/03 04 21.05.19 20.05.24

39 Preventive Maintenance of Manufacturing Vessels (Cream) EN/050/04 04 21.05.19 20.05.24

Preventive Maintenance of Bottle Filling Machine and Cap
40 EN/051/04 04 04.05.19 03.05.24
Sealing Machine (Pharmalab)
Preventive Maintenance of Automatic Tube Filling & Sealing
41 EN/052/04 04 23.05.19 22.05.24
Machine
Preventive Maintenance of Linear Bottle Washing Machine
42 EN/053/04 04 04.05.19 03.05.24
(Pharmalab)
43 Preventive Maintenance of Bottle Dryer Machine EN/055/04 04 07.01.19 06.01.24
Preventive Maintenance of Self Adhesive Labeling Machine
44 EN/057/04 04 25.05.19 22.05.24
(Pharmalab)
Preventive Maintenance of Pam-Glatt Fluid Bed Processor (Pam-
45 EN/058/04 04 16.03.19 15.03.24
Glatt)
46 Preventive Maintenance of Fluid Bed Dryer (NR) EN/059/04 04 05.05.19 04.05.24
47 Preventive Maintenance of High Speed Mixer Machine (NR) EN/060/04 04 07.05.19 06.05.24
48 Preventive Maintenance of Super Mixer Granulator EN/061/04 04 07.05.19 06.05.24
49 Preventive Maintenance of Cone Mill EN/062/04 04 25.05.19 24.05.24
50 Preventive Maintenance of Lifting & Tilting Device EN/063/04 04 02.06.19 01.06.24
51 Preventive Maintenance of Comminuting Mill Machine EN/064/04 04 02.06.19 01.06.24
52 Preventive Maintenance of Pharma Lifter (Canaan) EN/065/04 04 02.06.19 01.06.24
53 Preventive Maintenance of Multi Mill Machine EN/066/04 04 06.01.19 05.01.24
54 Preventive Maintenance of Drum Blender Machine EN/067/04 04 07.01.19 06.01.24

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

31 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Engineering Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date
55 Preventive Maintenance of Mix- Bin,(IBC Blender) EN/068/04 04 16.03.19 15.03.24
Preventive Maintenance of Rotary Tablet Press Machines (MRC-
56 EN/069/04 04 16.03.19 15.03.24
37D A.W.C, Sejong
Preventive Maintenance of Single Rotary Tableting Machine,
57 EN/070/04 04 16.03.19 15.03.24
(CPMD3-16)
Preventive Maintenance of Automatic Coating System (SFC-130
58 EN/071/04 04 11.05.19 10.05.24
FSN, Sejong)
59 Preventive Maintenance of Film Coating Machine (NR) EN/072/04 04 09.05.19 08.05.24
Preventive Maintenance of Automatic Capsule Filling Machine
60 EN/073/04 04 09.05.19 08.05.24
(Zanasi-40F)
61 Preventive Maintenance of Blister Packaging Machine EN/074/04 04 27.09.18 26.09.23
Preventive Maintenance of Automatic Blister Packaging Machine
62 EN/075/05 05 23.11.21 22.11.26
(Buchon)
63 Preventive Maintenance of Conveyor Belt (Solid & LCO) EN/076/05 05 07.06.23 06.06.28
64 Preventive Maintenance of Powder Filling Machine (All FiLL) EN/077/04 04 02.06.19 01.06.24

65 Preventive Maintenance of R.O.P.P Cap Sealing Machine (Mark) EN/078/04 04 02.06.19 01.06.24
Preventive Maintenance of Automatic Tablet Counting and Filling
66 EN/079/04 04 08.05.20 07.05.25
Machine
67 Preventive Maintenance of Label and Box Printer EN/080/04 04 14.05.19 13.05.24
68 Performance Monitoring of HVAC System EN/082/06 06 15.01.21 14.01.26
69 Calibration of Temperature & % RH Sensor EN/086/06 06 23.01.23 22.01.28
70 Calibration of Disintergration Tester EN/087/04 04 15.12.20 14.12.25
71 Calibration of Tapped Density Tester EN/088/04 04 30.03.20 29.03.25
72 Calibration of Weighing Balances EN/089/04 04 15.05.19 14.05.24
Preventive Maintenance of Self Adhesive Labeling Machine (KK
73 EN/092/03 03 02.06.19 01.06.24
& KK)
Operation, Calibration, Maintenance & Function Check of Vernier
74 EN/094/03 03 04.08.18 03.08.23
Caliper and Micrometer Screw Gauge
75 Intensity of Light Measurement EN/095/03 03 11.08.18 10.08.23
Operation & Maintenance of Purified Water Plant (LVP/AMINO &
76 EN/097/03 03 08.08.18 07.08.23
CEPH.)
Preventive Maintenance of Tablet Compression Machine (NRIR-
77 EN/100/03 03 17.05.19 16.05.24
13D)
Preventive Maintenance of Pharma Lifter (NTD-800)
78 EN/102/03 03 17.05.19 16.05.24
Preventive Maintenance of Bottle Washing Machine
79 EN/104/03 03 17.05.19 16.05.24
(YC-BW-18B)
Preventive Maintenance of Self Adhesive Labeling Machine (Self
80 EN/106/03 03 31.08.19 30.08.24
-adhesive)

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

32 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Engineering Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date
Preventive Maintenance of Liquid Vial Capping Machine
81 EN/110/03 03 30.12.19 29.12.24
(ZG 300C)
Preventive Maintenance of Liquid Vial Filling and Stoppering
82 EN/111/03 03 30.12.19 29.12.24
Machine (DGS4D)
Preventive Maintenance of Vial Washing Machine
83 EN/112/03 03 30.12.19 29.12.24
(E CHUNG)
Preventive Maintenance of Pre-Filled Syringe Filling and
84 EN/113/03 03 30.12.19 29.12.24
Stoppering Machine
85 Preventive Maintenance of Steam Sterilizer-6.6.6-2V (Sanamij) EN/114/03 03 30.12.19 29.12.24

Preventive Maintenance of Self Adhesive Labeling Machine (KK-

86 EN/116/03 03 30.12.19 29.12.24
906)
87 Temperature & Humidity Calibration for Stability Chamber EN/120/03 03 24.06.19 23.06.24
Preventive Maintenance of Automatic Injectable Powder Filling
88 EN/121/03 03 12.03.19 11.03.24
and Rubber Stoppering Machine (Ambica)
Preventive Maintenance of Automatic Rotary Vial Washing
89 EN/122/03 03 12.03.19 11.03.24
Machine (Ambica)
90 Preventive Maintenance of Dispensing Booth, EN/125/03 03 17.02.19 16.02.24
91 Preventive Maintenance of High Speed Mixer Granulator (JIAFA) EN/127/03 03 17.02.19 16.02.24
92 Preventive Maintenance of Blender Machine EN/128/03 03 17.02.19 16.02.24
Preventive Maintenance of Tablet compression machine
93 EN/129/03 03 17.02.19 16.02.24
(GRC15SA.W.C)
Preventive Maintenance of Automatic Blister Pack Machine
94 EN/131/05 05 07.06.23 06.06.28
(Hoonga)
Preventive Maintenance of Container Filling machine
95 EN/133/03 03 12.02.19 11.02.24
(Pharmalab)
96 Preventive Maintenance of Container Washing Machine EN/134/03 03 12.02.19 11.02.24
97 Preventive Maintenance of Autoclave (Sterimega 350) EN/135/03 03 17.05.19 16.05.24
98 Preventive Maintenance of Dry Heat Sterilizer, Pyromega -1000 EN/136/04 04 08.08.22 07.08.27
99 Preventive Maintenance of Autoclave (Sterimega 350) EN/137/04 04 08.08.22 07.08.27
Preventive Maintenance of Rotary Tablet Press Machine (MRC-
100 EN/141/03 03 16.03.19 15.03.24
61D,Sejong).
Preventive Maintenance of Blender Machine
101 EN/145/03 03 07.11.18 06.11.23
102 Calibration of Filter Integrity Tester (Sartocheck 4 Plus) EN/148/02 02 25.08.18 24.08.23
Operation & Maintenance of Water for Injection Plant for
103 EN/150/04 04 19.02.23 18.02.28
Penicillin Facility
Operation & Maintenance of Purified Water Plant
104 EN/153/03 03 30.05.20 29.05.25
(Hormone Building)

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

33 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Engineering Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date
105 Preventive Maintenance of Automatic Sachet Packaging Machine EN/155/03 03 10.05.19 09.05.24
106 Calibration of Weight EN/157/02 02 23.05.19 22.05.24
107 Operation and Maintenance of Cold Room Refrigeration System EN/158/04 04 19.06.23 18.06.28
108 Preventive Maintenance of LAF Module EN/159/02 02 03.01.20 02.01.25
Operation & Maintenance of Pure Steam Generator of Hormone
109 EN/160/03 03 23.12.20 22.12.25
Injectable Facility
110 Calibration Procedure for Dissolution Tester EN/162/02 02 25.08.20 24.08.25
111 Calibration for Hardness Tester EN/163/02 02 04.06.20 03.06.25
112 On the Job Training for Engineering Personnel EN/165/01 01 20.08.18 19.08.23
113 Operation and Maintenance of PSA Nitrogen Generator EN/166/04 04 10.05.19 09.05.24
114 Operation of Stacker Truck (EMC 110/B10) EN/167/03 03 09.05.19 08.05.24
Operation of Superheated Water Spray Autoclave
115 EN/168/03 03 11.05.19 10.05.24
(Fedegari- FOW8/DD)
116 Facility, Utility & Equipment Qualification EN/172/03 03 28.06.21 27.06.26
Preventive Maintenance of Super Heated Water Spray
117 EN/174/03 03 06.09.19 05.09.24
Autoclave (FEDEGARI)
Preventive Maintenance of Automatic Capsule Filling Machine
118 EN/175/02 02 09.03.21 08.03.26
(PZ-40)
Preventive Maintenance of Automatic Coating System
119 EN/176/01 01 31.12.19 30.12.24
(SFC-150,Sejong)
120 Preventive Maintenance of Fluid Bed Dryer (Alliance) EN/177/01 01 31.12.19 30.12.24
121 Preventive Maintenance of HAPA 230 Foil Printing Machine EN/178/01 01 06.02.20 05.02.25
Preventive Maintenance of Vertical Ultrasonic Vial Washing
122 EN/179/01 01 17.03.20 16.03.25
Machine
Preventive Maintenance of Circulating Heating Air Tunnel Oven
123 EN/181/01 01 17.03.20 16.03.25
Sterilizer
Preventive Maintenance of Automatic Labeling Machine
124 EN/182/02 02 08.08.22 07.08.27
(TB 200)
125 Preventive Maintenance of Shinva Sterilizer EN/183/01 01 17.03.20 16.03.25
Preventive Maintenance of Ampoule Filling and Sealing Machine
126 EN/184/01 01 17.03.20 16.03.25
(R911/MA)
Preventive Maintenance of Lyophilizer (Lyo-10, SIP and CIP)
127 EN/185/01 01 22.03.20 21.03.25
Machine
Preventive Maintenance of Lyophilizer (Lyo-2, SIP and CIP)
128 EN/186/01 01 22.03.20 21.03.25
Machine
129 Preventive Maintenance of Tablet Press Machine (Fette) EN/187/01 01 30.05.20 29.05.25

130 EN/188/01 01 30.05.20 29.05.25

Preventive Maintenance of Automatic Coating Machine (Sejong)

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

34 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Engineering Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date
131 Preventive Maintenance of Coating Machine (YC-SC-100F) EN/189/01 01 09.06.20 08.06.25
132 Preventive Maintenance of Coating Machine (NR) EN/190/01 01 09.06.20 08.06.25
Operation and Maintenance procedure of Gas Generator 200
133 EN/191/02 17.11.21 16.11.26
KGPH 02

134 Operation and Maintenance of Pure Steam Generator 200 KGPH EN/192/01 01 31.12.22 30.12.27
135 Preventive Maintenance of Manufacturing Vessels EN/193/00 00 01.10.18 30.09.23
136 Preventive Maintenance of Inject Printer EN/194/00 00 25.10.18 24.10.23
Preventive Maintence of Filling and Closing Machine for
137 EN/195/00 00 01.11.18 31.10.23
Ampoules (R960MA)
138 Preventive Maintence of Dry Heat Sterilizer (XRSHX-IIIJ) EN/196/00 00 01.11.18 31.10.23
139 Preventive Maintence of Vial Filling Machine (Electrolab) EN/197/00 00 01.11.18 31.10.23
Preventive Maintence of Horizontal Ampoule Labeler
140 EN/198/00 00 01.11.18 31.10.23
(CVC 350U)
141 Preventive Maintence of Insulin Cartridge Washing Machine EN/199/00 00 01.11.18 31.10.23
142 Preventive Maintenance of Manufacturing Vessel 30 Liter EN/200/00 00 01.11.18 31.10.23
Preventive Maintenance of Manufacturing Vessel 70 Liter
143 EN/201/00 00 01.11.18 31.10.23
with Load Cell
144 Operation and Maintenance of Diesel Generator EN/202/00 00 07.11.18 06.11.23
Operation & Maintenance of 1500 Liter Purified Water Plant for
145 EN/203/01 01 01.11.21 31.10.26
Sterile & Hormone Building
Operation & Maintenance of Water for Injection Plant for Sterile
146 EN/204/01 01 28.02.22 27.02.27
Building
Preventive Maintence of Automatic Form Fill Seal Line
147 EN/205/00 00 25.12.18 24.12.23
(FFS 892)
Preventive Maintence of Automatic High speed Injectable Liquid
148 EN/206/00 00 26.12.18 25.12.23
Filling with Rubber Stopper Machine
149 Preventive Maintence of Bottle Filling Machine (Plumat) EN/207/00 00 26.12.18 25.12.23
150 Preventive Maintence of Bottle Washing Machine EN/208/00 00 25.12.18 24.12.23
151 Preventive Maintence of Cap Sealing Machine EN/209/00 00 29.12.18 28.12.23
152 Preventive Maintence of Desktop Filling Machine EN/210/00 00 29.12.18 28.12.23
Preventive Maintence of Automatic High speed Wet Glue
153 EN/211/00 00 30.12.18 29.12.23
Labeling Machine
Preventive Maintence of High Frequency Plastic Welding
154 EN/212/00 00 29.12.18 28.12.23
Machine (Bag Forming)
Preventive Maintence of High Frequency Plastic Welding
155 EN/213/00 00 30.12.18 29.12.23
Machine (Port welding)
156 Preventive Maintenance of High Pressure Homogenizer EN/214/00 00 01.01.19 31.12.23
157 Preventive Maintenance of Manufacturing Vessel EN/215/00 00 01.01.19 31.12.23

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

35 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Engineering Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date
Preventive Maintenance of Self Adhesive Labeling Machine
158 EN/216/00 00 01.01.19 31.12.23
(Ambica)
Preventive Maintenance of Semi Automatic Filler Capper (FC
159 EN/217/00 00 01.01.19 31.12.23
400)
160 Preventive Maintenance of Storage Vessel EN/218/00 00 02.01.19 01.01.24
161 Preventive Maintenance of Vacuum Stopper Matchine (Plumat) EN/219/00 00 02.01.19 01.01.24
162 Preventive Maintenance of Bottle Washing Machine EN/220/00 00 10.01.19 09.01.24
163 Preventive Maintenance of Double Cone Blender Machine EN/221/00 00 10.01.19 09.01.24
164 Preventive Maintenance of Hauser Auger Filling Machine EN/222/00 00 19.01.19 18.01.24
165 Preventive Maintenance of Vial Cap Sealing Machine EN/223/00 00 19.01.19 18.01.24
166 Preventive Maintenance of Vial Filling Line (PFI) EN/224/00 00 19.01.19 18.01.24
167 Operation and Maintenance of Electric Reach Truck EN/225/00 00 14.01.19 13.01.24
Installed HEPA Filter System Leakage Test using Aerosol
168 EN/226/01 01 05.01.23 04.01.28
Photometer and Aerosol Generator
169 Preventive Maintenance of Manufacturing vessel with Stirrer EN/227/00 00 09.02.19 08.02.24
Preventive Maintenance of Tablet Compression Machine
170 (Cadmach) EN/228/00 00 09.02.19 08.02.24
171 Preventive Maintenance of Manufacturing Vessel EN/229/00 00 16.03.19 15.03.24
172 Preventive Maintenance of Blister Pack Machine (Uhlmann) EN/230/00 00 20.03.19 19.03.24
173 Preventive Maintenance of Cartoning Machine (Uhlmann) EN/231/00 00 20.03.19 19.03.24
174 Preventive Maintenance of Bin Mixer (YC-BM-500) EN/232/00 00 06.05.19 05.05.24
175 Preventive Maintenance of Tablet Compression Machine EN/233/00 00 30.04.19 29.45.24
Preventive Maintenance of Tablet Compression Machine (JSH-
176 EN/234/00 00 30.04.19 29.45.24
412)
177 Preventive Maintenance of Bottle Filling Machine (LFM-500) EN/235/00 00 08.05.19 07.05.24
Preventive Maintenance of Automatic Sachet Filling Machine
178 EN/236/00 00 08.05.19 07.05.24
(QD-60A)
Preventive Maintenance of induction Cap Sealing Machine
179 EN/237/00 00 20.06.19 19.06.24
(SIGMA I ACE)
180 Preventive Maintenance of Autoclave (FEDEGARI-NA3038BA) EN/238/00 00 19.06.19 18.06.24
181 Preparation of Qualification/Re-Qualification Protocol & Report EN/239/03 03 05.01.23 04.01.28
182 Performance Test  of Safety Relief Valve/Pressure Relief Valve EN/240/00 00 19.09.19 18.09.24
183 Operation of Kaye Validator AVS System EN/241/00 00 01.10.19 30.09.24
Preventive Maintenance of Vial Filling and Stoppering Machine
184 EN/242/00 00 27.10.19 26.10.24
(ROTA FLL201/G)
Preventive Maintenance of Vial Capping and Crimping Machine
185 EN/243/00 00 23.10.19 22.10.24
(ROTA FLR201/B)
Preventive Maintenance of Two Side Hologram Sticker Labeling
186 EN/244/00 00 28.07.21 27.07.26
Machine (AL 320)

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

36 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Engineering Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date
Preventive Maintenance of Eye Drop Filling, Plugging and Over
187 EN/245/00 00 02.01.20 01.01.25
Capping Machine (ROTA-FLL 201/TS)
Preventive Maintenance of Automatic Caroning Machine
188 EN/246/00 00 07.04.20 06.04.25
(Hoonga)
Preventive Maintenance of Rotary Tablet Press Machine (MRC-
189 EN/247/00 00 17.06.20 16.06.25
61D,Sejong).
190 Preventive Maintenance of Vial Serialization Tunnel (Tofflon) EN/248/00 00 15.10.20 14.10.25
191 Assets Transfer and Disposal System EN/249/00 00 19.01.21 18.01.26
192 Preventive Maintenance of Bag Filling and Sealing Machine EN/250/00 00 14.02.21 13.02.26
193 Preventive Maintenance of Storage Vessel EN/251/00 00 06.02.21 05.02.26
194 Preventive Maintenance of Blending Machine (Cosmec) EN/252/00 00 14.03.21 13.03.26
Preventive Maintenance of Automatic Capsule Filling Machine
195 EN/253/00 00 28.02.21 27.02.26
(Harro)
Preventive Maintenance of Automatic Coating Machine (GCSi-
196 EN/254/00 00 28.02.21 27.02.26
700,Glatt)
Preventive Maintenance of Automatic Tablet Compression
197 EN/255/00 00 28.02.21 27.02.26
Machine (Kilian-720)
198 Management of Engineering Store Activities EN/256/01 01 23.02.23 22.02.28
199 Preventive Maintenance of Bio- Safety Cabinet EN/257/00 00 29.06.21 28.06.26
Preventive Maintenance of Automatic Sachet Filling and
200 EN/258/00 00 12.08.21 11.08.26
Packaging Machine (SANKO)
201 Preventive Maintance of Blister Pack Machine (Uhlmann) EN/259/00 00 16.08.21 15.08.26
202 Preventive Maintenance of Auto Cartoning Machine (Uhlmann) EN/260/00 00 16.08.21 15.08.26
203 Preventive Maintenance of Sifter EN/261/00 00 04.09.21 03.09.26
204 Preventive Maintenance of High Shear Granulator (Glatt) EN/262/00 00 04.09.21 03.09.26
205 Preventive Maintenance of Fluid Bed Processor (Glatt) EN/263/00 00 04.09.21 03.09.26
206 Operation of IAQ Measuring Instrument. EN/264/00 00 04.11.21 03.11.26
Preventive Maintenance of Automatic Blister Pack Machine
207 EN/265/00 00 12.06.22 11.06.27
(Hoonga-HM AV)

208 Preventive maintenance of automatic Inspection machine (CMP) EN/266/00 00 22.06.22 21.06.27
Operation & Maintenance of Water for Injection Plant for
209 EN/267/00 00 28.02.22 27.02.27
Hormone Building
Preventive Maintenance of Labeling Machine (SUN JIN SM, SP-
210 EN/268/00 00 29.03.22 28.03.27
3300W)
211 Preventive Maintenance of Autoclave (FEDEGARI- NA3353BC) EN/269/00 00 12.06.22 11.06.27
212 Preventive Maintenace of Double Cone Blender EN/270/00 00 20.04.22 19.04.27
213 Preventive maintenance of Double Cone Blender (500 Liter) EN/271/00 00 29.06.22 28.06.27
214 Preventive Maintenance of Vial Washing Machine (QCL60) EN/272/00 00 14.06.22 13.06.22

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

37 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Engineering Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date
Operation & Maintenance of 10000 L/H Purified Water Plant for
215 EN/273/00 00 24.03.22 23.03.27
Solid & LVP Facility
Operation & Maintenance Of Water For Injection Plant for LVP
216 EN/274/00 00 24.03.22 23.03.27
Facility
Operation & Maintenance Of Water For Injection Generation
217 EN/275/00 00 15.09.22 14.09.27
Plant (LVP/AMINO)
218 Preventive Maintenance of Bottle Washing Machine (LW-CFW) EN/276/00 00 17.10.22 16.10.27
219 Preventive Maintenance of Liquid Filling Machine (LW-S8QF) EN/277/00 00 17.10.22 16.10.27
220 Preventive Maintenance of Capping Machine (LW-AA) EN/278/00 00 17.10.22 16.10.27
221 Preventive Maintenance of Manufacturing Vessel (300L) EN/279/00 00 17.10.22 16.10.27
222 Preventive Maintenance of Manufacturing Vessel (1500L) EN/280/00 00 17.10.22 16.10.27
223 Preventive Maintenance of Storage Vessel (1500L) EN/281/00 00 17.10.22 16.10.27
Preventive Maintenance of Monoblock Rotary Filler & Capper
224 EN/282/00 00 17.10.22 16.10.27
(LW-16QF6S)
225 Operation & Maintenance for Pure Steam Generator 450 KGPH EN/283/00 00 19.02.23 18.02.28
Preventive Maintenance of Sachet Filling & Sealing Machine
226 EN/286/00 00 13.03.23 12.03.28
(SDXD15)
Preventive Maintenance of Tablet Compression Machine (Accra
227 EN/287/00 00 14.03.23 13.03.28
PRESS IV)
Preventive Maintenance of GANSONS Fluidized Bed Processor
228 EN/288/00 00 14.03.23 13.03.28
GFBP150)
Preventive Maintenance of High Shear Mixer Granulator (HSMG
229 EN/289/00 00 14.03.23 13.03.28
150)
230 Preventive Maintenance of Conveyor Belt (Cephalosporin) EN/290/00 00 07.06.23 06.06.28
231 Preventive Maintenance of Conveyor Belt (Penicillin) EN/291/00 00 07.06.23 06.06.28
232 Preventive Maintenance of Conveyor Belt (Animal Health) EN/292/00 00 08.06.23 07.06.28
233 Preventive Maintenance of Conveyor Belt (Sachet) EN/293/00 00 08.06.23 07.06.28
234 Preventive Maintenance of Conveyor Belt (Hormone Solid) EN/294/00 00 08.06.23 07.06.28
235 Preventive Maintenance of Conveyor Belt (Hormone Injectable) EN/295/00 00 08.06.23 07.06.28

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

38 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Product Development Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

1 Stability Study PD/001/04 04 29.03.19 28.03.24

Entry & Exit Procedure in Formulation Laboratory of Product
2 Development Department PD/002/06 06 16.03.23 15.03.28
Entry & Exit Procedure in Analytical Laboratory of Product
3 Development Department PD/003/06 06 16.03.23 15.03.28
4 Operation and Cleaning of Compression Machine PD/004/04 04 16.10.19 15.10.24
5 Operation and Cleaning of Film and Sugar Coating Machine PD/005/04 04 16.10.19 15.10.24
6 Operation and Cleaning of Fluid Bed Dryer PD/006/04 04 07.11.19 06.11.24
7 Operation and Cleaning Procedure of High Speed Mixer PD/007/04 04 09.11.19 08.11.24
8 Lab Batch Manufacturing PD/008/05 05 28.12.19 27.12.24
9 Pilot Batch Manufacturing PD/009/05 05 28.12.19 27.12.24
10 Trial Batch Manufacturing PD/011/05 05 28.06.19 27.06.24
Operation,Cleaning and Calibration of Stability Chamber [CAVALLO
11 Comm Model C4TAU ]
PD/012/04 04 06.05.20 05.05.25

Operation and Calibration of UV-Visible Spectrophotometer (Model-

12 UV 1650 PC) PD/013/04 04 06.05.20 05.05.25
13 Operation and Calibration of Shaker (Model-3017) PD/014/04 04 16.05.20 15.05.25
Operation, Maintenance, Cleaning & calibration of IR Moisture
14 analyzer [ Sartorius Model MA 45 ]
PD/015/04 04 11.06.20 10.06.25
15 Operation, Calibration and Cleaning of Water Bath (Model-1005) PD/017/04 04 26.06.20 25.06.25
Operation, Calibration and Cleaning of Disintegration Tester (Model-
16 ZT 301) PD/018/04 04 02.07.20 01.07.25
17 Operation of Water Purification System (Model-Arium 611DI) PD/019/04 04 06.07.20 05.07.25
Operation, Maintenance & Cleaning and Calibration of Friability
18 Tester [ Model PTF 20E ]
PD/020/04 04 10.07.20 09.07.25

Operation, Maintenance and Cleaning of Tablet Hardness Tester

19 [ Model PTB 302 ] PD/024/04 04 02.08.20 01.08.25
20 Use & Maintenance of Refrigerator PD/029/04 04 05.10.20 04.10.25
21 Operation and Cleaning of Drying Oven PD/030/04 04 05.10.20 04.10.25
Operation, Cleaning and Calibration of Mettler Toledo Melting Point
22 Apparatus PD/031/04 04 05.10.20 04.10.25
Preparation of Batch Manufacturing Records (BMR) & Batch
23 PD/033/05 05 14.03.23 13.03.28
Packaging Records (BPR)
Operation, Calibration & Maintenance of Shimadzu HPLC
24 [ Model-Prominence ]
PD/034/03 03 28.06.20 27.06.25

Preparation of Specification and Standard Test Procedure for

25 Finished Product PD/035/02 02 12.11.18 11.11.23
26 Maintenance of HPLC Column PD/036/02 02 19.11.18 18.11.23

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

39 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Product Development Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

27 Preparation and Maintenance of Working Standard PD/037/02 02 07.02.20 06.02.25

Receiving, Storage and Preparation of Laboratory Reagents
28 PD/038/02 02 13.06.20 12.06.25
and Solvents
Management, Calibration and Maintenance of Laboratory
29 PD/039/02 02 16.06.20 15.06.25
Glasware
30 Procedure for Method Transfer PD/040/02 02 01.03.21 28.02.26
Operation, Calibration and Cleaning of Dissolution Test Apparatus
31 (Model DT 1420)
PD/041/01 01 15.08.18 14.08.23
32 Qualification & Training of PD Personnel PD/043/01 01 31.08.18 30.08.23
Operation and Maintenance of HPLC [Model Agilent 1260
33 PD/044/01 01 02.10.19 01.10.24
Infinity]
Operation, Cleaning and Calibration of Ultrasonic Bath
34 PD/045/01 01 02.10.19 01.10.24
(Model-520)
35 Calibration of HPLC [Model Agilent 1260 Infinity] PD/046/01 01 02.12.19 01.12.24
36 Analyst Validation Procedure PD/047/01 01 26.03.20 25.03.25
Lab Batch and Pilot Batch Numbering System for Products
37 PD/048/01 01 31.03.20 30.03.25
Under Development
38 Operation and Calibration of pH Meter PD/049/01 01 16.03.23 15.03.28
39 Log Book for Machine and Equipment PD/050/00 00 10.04.19 09.04.24
Operation, Calibration , Maintenance and Cleaning of Precision
40 Balance [ Sartorius Quintix5102-1S] PD/051/00 00 09.04.19 08.04.24

Operation and Calibration of Shimadzu HPLC [ Model : Prominence-

41 i ] PD/052/00 00 17.07.20 16.07.25
Operation and Maintenance of Shimaddzu HPLC
[Model:Prominence-I Plus,ID:620-PDL-753-06]
42 PD/054/00 00 21.04.19 20.04.24
Infinity]
Calibration of HPLC [Model:Shimadzu Prominence-i Plus,
ID:620-PDL-753-06]
43 PD/055/00 00 21.04.19 20.04.24
Infinity]
Operation and Maintenance of Shimaddzu HPLC
[Model:Prominence-I Plus,ID:620-PDL-753-07]
44 PD/056/00 00 22.04.19 21.04.24
Infinity]
Calibration of HPLC [Model:Shimadzu Prominence-i
Plus,ID:620-PDL-753-07]
45 PD/057/00 00 22.04.19 21.04.24
Infinity]

Operation, Calibration , Maintenance and Cleaning of Digital

46 Weighing Balance [ Sartorius Quintix 224-1S,ID. :620-PDL-745-03] PD/059/00 00 28.03.19 27.03.24

Monitoring of Temperature and Relative Humidity in Product

47 PD/060/00 00 10.06.19 09.06.24
Development Area

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

40 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Product Development Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

Operation, Calibration , Maintenance and Cleaning of Digital

48 Weighing Balance [ Sartorius Quintix 224-1S] PD/061/01 01 22.03.23 21.03.28

Operation and Maintenance of Thrombolyzer

49 PD/062/00 00 29.05.19 28.05.24
[Model: XR, ID: 740-QCL-780-01]
Operation and Calibration of Shaker
50 PD/063/00 00 12.05.20 11.05.25
[Model: 3017, ID: 620-PDL-718-02]
Operation and Calibration of UV-Visible Spectrophotometer
51 [ Model : UV-1900] PD/064/00 00 09.05.20 08.05.25
Operation, Calibration and Maintenance of Refrigerator [ Model : SJ-
52 VX79E-SL] PD/065/00 00 11.05.20 10.05.25
53 Operation and Calibration of Drying Oven [ Model : UF-30] PD/066/00 00 11.05.20 10.05.25
Operation, Cleaning and Calibration of Shaking Water Bath
54 [ Model : 1083]
PD/067/00 00 11.05.20 10.05.25
Operation and Maintenance of Centrifuge Machine
55 [ Model : Z 326, ID : 740-PDL-711-01]
PD/068/00 00 11.05.20 10.05.25
56 New Product Development Procedure PD/069/01 01 19.04.23 18.04.28
57 Operation and Cleaning of Laboratory Mixer and SS Bin PD/070/00 00 23.10.19 22.10.24
Operation, Calibration ,Cleaning and Maintenance of Analytical
58 Balance RADWAG [Model:AS 310.R2] PD/071/00 00 23.10.19 22.10.24
59 Operation and Cleaning of Oil Bath [Model : ONE 10] PD/072/00 00 11.05.20 10.05.25
60 Operation and Cleaning of Gansons Comminuting Mill PD/073/00 00 16.03.21 15.03.26
61 Operation and Maintenance of Photostability Chamber PD/074/00 00 12.01.21 11.01.26
62 Operation and Cleaning of Liquid Manufacturing Vessel 10 L) PD/075/00 00 16.03.21 15.03.26
63 Operation and Cleaning of Tube Sealing Machine PD/076/00 00 27.02.21 26.02.26
64 Operation, Maintenance & Qualification of Laminar Air Flow Unit PD/077/00 00 16.03.21 15.03.26
Operation and Cleaning of Pharma Chem Manual Encapsulation
65 Machine PD/078/00 00 02.03.21 01.03.26
66 Operation and Cleaning of Digital high Speed Stirrer PD/079/00 00 19.03.21 18.03.26
67 Operation and Cleaning of Laboratory Disperser PD/080/00 00 19.03.21 18.03.26
68 Operation and Maintenance of Magnetic Stirrer with Hot Plate PD/081/00 00 22.03.21 21.03.26
Operation, Calibration, Maintenance of Shimadzu HPLC [Model -
69 Prominence with Conductivity Detector] PD/082/00 00 04.01.21 03.01.26
70 Dispensing of Raw Materials PD/083/00 00 15.03.21 14.03.26
71 Operation and Cleaning of Pharma Chem Automatic Capsule Loader PD/084/00 00 15.03.21 14.03.26

Operation, Calibration, Maintenance and Cleaning of Weighing

72 Balance PD/085/00 00 11.03.21 10.03.26

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

41 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Product Development Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

Operation and Cleaning of Cream & Ointment Manufacturing

73 PD/086/00 00 18.03.21 17.03.26
Machine
Operation, Calibration and Maintenance of Dissolution Tester
74 PD/087/00 00 28.06.21 27.06.26
[Model: CD14]
Operation and Maintenance of IR Spectrophotometer
75 PD/088/00 00 21.08.21 20.08.26
[Model-IRSpirit]
76 Operation and Cleaning of Dispensing Booth PD/089/00 00 30.03.22 29.03.27
Operation, Maintenance, Cleaning and Calibration of
77 PD/090/00 00 20.04.22 19.04.27
Moisture Analyzer [Model: MB 120]
Operation, Maintenance and Cleaning of COPLEY Hardness
78 PD/091/00 00 30.03.22 29.03.27
Tester [Model TBF100i]
79 Operation,cleaning and Calibration of Stability Chambers PD/092/00 00 22.03.23 21.03.28
Operation and Maintenance Osmometer [Model- OsmoTouch
80 PD/093/00 00 19.06.22 18.06.27
1]
Operation, Calibration and Maintenance of Particle Size
81 PD/094/00 00 19.06.22 18.06.27
Analyzer [Model: Mastersizer 3000]
82 Operation and cleaning of Flowability Tester PD/095/00 00 29.11.22 28.11.27
Operation and Maintenance of shamadzu HPLC
83 [Model: Prominence -I plus ,With PDA Detector] PD/097/00 00 22.03.23 21.03.28

84 Calibration of HPLC [Model: shimadzu Prominance - I Plus ] PD/098/00 00 22.03.23 21.03.28

85 PD/099/00 00 16.03.23 15.03.28

Operation and Maintenance of Magnetic Stirrer with Hot Plate
Operation, Calibration and Maintenance of Pharmatest
86 Dissolution Tester [Model PTWS IIIE] PD/100/00 00 22.03.23 21.03.28

87 Operation and Maintenance of Drying Oven [ Model: VC 404 PD/101/00 00 16.03.23 15.03.28
ECO]
88 Operation and Maintenance of Filtration Unit PD/102/00 00 16.03.23 15.03.28
89 Operation and Cleaning of Vortex Mixer PD/103/00 00 16.03.23 15.03.28
90 Operation and Cleaning of Fume Cupboard PD/104/00 00 16.03.23 15.03.28
91 Operation and Calibration of Shaker [Model: VS 15 0] PD/105/00 00 16.03.23 15.03.28
Operation, Calibration, Maintenance & Cleaning of Anton
92 PD/106/00 00 22.03.23 21.03.28
paar Polarimeter ( Model : MCP 5100 ).
93 Handling of Intermediate, Bulk and Finished Product PD/109/00 00 16.03.23 15.03.28
94 Disposal of Laboratory Waste PD/110/00 00 16.03.23 15.03.28

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

42 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Quality Control Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date
1 Quality Control Laboratory Set-up & Standard Activity QC/001/05 05 13.06.19 12.06.24
2 Physical, Chemical & Instrumental Analysis QC/002/05 05 13.07.19 12.07.24
Copntrol of Personnel Entry/Exit in Quality Control Laboratory
3 QC/003/05 05 16.08.19 17.08.24
4 Qualification & Calibration of Analytical Instruments QC/004/05 05 16.09.19 15.09.24
5 Management, Calibration & Maintenance of Glassware QC/005/05 05 22.06.19 21.06.24
6 Qualification & Training of QC Personnel QC/006/04 04 29.12.19 28.12.24
Preparation, Handling & Use of Reference Standard/Working
7 QC/007/05 05 25.07.19 24.07.24
Standard
Preparation & Storage of Laboratory Chemicals &
8 QC/008/05 05 22.06.19 21.06.24
Reagents
9 Disposal of Laboratory Wastage QC/009/04 04 03.02.20 02.02.25
10 Preparation, Storage & Uses of 70% IPA Solution QC/011/02 02 05.05.20 04.05.25
Operation, Calibration & Maintenance of Drying Oven
11 QC/012/03 03 13.09.18 12.09.23
[ Binder Drying Oven : FED400 ]
12 Operation, Cleaning & Calibration of Sampling Booth QC/013/04 04 06.01.20 05.01.25
13 Cleaning of Sampling Tools QC/014/04 04 06.01.20 05.01.25
Operation, Calibration & Maintenance of Analytical Balance
14 QC/015/03 03 30.09.18 29.09.23
[METTLER TOLEDO Model PB4002-S] AB-3
15 Sampling of Raw Materials QC/016/05 05 06.09.19 05.09.24
16 Sampling of Packaging Materials QC/017/04 04 31.08.18 30.08.23
Operation, Calibration & Maintenance of Analytical Balance
17 QC/018/03 03 30.09.18 29.09.23
[METTLER TOLEDO Model PB4002-S] AB-4
18 Release, Rejection & Retest of Incoming Materials QC/019/07 07 26.10.22 25.10.27
Operation, Calibration & Maintenance of Analytical Balances
19 QC/020/02 02 28.06.20 27.06.25
[SHIMADZU Model : TX223L]
Operation & Calibration of Osmometer (Model : Osmomat
20 QC/021/02 02 16.03.23 15.03.28
3000D)
Operation, Calibration & Maintenance of Pharma Test
21 QC/022/02 02 11.11.20 10.11.25
Hardness Tester (Model: PTB 511E)
22 Out of Specification Handling QC/023/05 05 23.05.21 22.05.26
Operation, Calibration & Maintenance of Brookfield Digital
23 QC/024/04 04 04.04.23 03.04.28
Viscometer [ Model : RVDV-I + ]
24 Operation, Cleaning and Calibration of Heating Block QC/025/02 02 20.10.20 19.10.25
Operation, Calibration & Maintenance of Shimadzu HPLC
25 QC/027/05 05 13.11.20 12.11.25
Instruments [ Model LC –2010A HT ] Quaternary Gradient
Operation, Calibration & Maintenance of Shimadzu Atomic
26 QC/028/04 04 08.10.19 07.10.24
Absorption Spectrophotometer [Model : AA-6300]
Operation, Calibration & Maintenance of Shimadzu UV –
27 QC/029/05 05 02.09.18 01.09.23
Visible Spectrophotometer [ Model UV -1650PC ]

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

43 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Quality Control Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date
Operation, Calibration & Maintenance of Pharmatest
28 QC/032/04 04 30.09.18 29.09.23
Dissolution Tester [Model PTWS IIIE]
Operation, Calibration & Maintenance of Mettler pH Meter
29 QC/033/04 04 13.09.18 12.09.23
[Model Seven-Easy]
Operation, Calibration & Maintenance of Mettler Karl-Fischer
30 QC/035/04 04 05.10.18 04.10.23
apparatus [METTLER TOLEDO Model DL32]
Operation, Calibration & Maintenance of Mettler Melting Point
31 QC/036/04 04 09.10.18 08.10.23
Apparatus [METTLER TOLEDO Model FP62]
Operation, Calibration & Maintenance of Drying Oven
32 QC/039/04 04 13.09.18 12.09.23
[Model : UFE 500]
Operation, Calibration & Maintenance of Memmert Water Bath
33 QC/040/04 04 29.12.19 28.12.24
[Model - GFL 1083]
Operation, Calibration & Maintenance of Tap Density Tester
34 QC/041/04 04 07.09.18 06.09.23
[Pharmatest Model - PT-TD1]
Operation, Calibration & Maintenance of Automatic
35 QC/042/04 04 09.10.18 08.10.23
Polarimeter [Model : AP-100]
Operation, Calibration & Maintenance of Digital Abbe
36 QC/043/04 04 12.10.18 11.10.23
Refractometer
Operation, Calibration & Maintenance of Vibratory Sieve
37 QC/044/04 04 30.01.20 29.01.25
Shaker [Model - Analysette 3]
Operation, Calibration & Maintenance of Hermle Centrifuge
38 QC/045/04 04 30.01.20 29.01.25
[Model - Z 400]
Operation, Qualification & Maintenance of NANOpure
39 QC/046/04 04 27.07.19 26.07.24
Diamond (Water Purification System) [Model : D 11941]
Operation, Qualification & Maintenance of Muffle Furnace
40 QC/047/04 04 13.09.18 12.09.23
[Model : LM 312.07]
Operation, Calibration & Maintenance of Analytical Balance
41 QC/048/05 05 05.12.19 04.12.24
[METTLER TOLEDO Model AB204-S]
Operation, Calibration & Maintenance of Vacuum Drying Oven
42 QC/049/04 04 30.01.20 29.01.25
[Binder Model - VD 23]
Operation, Calibration & Maintenance of Refrigerator
43 QC/050/04 04 03.03.20 02.03.25
[Model - FKG 311]
44 Environmental Monitoring QC/052/09 09 04.05.21 03.05.26
45 Preparation of Culture Media QC//054/06 06 10.09.21 09.09.26
Operation, Calibration & Maintenance of Pharma Test
46 QC/055/02 02 13.11.20 12.11.25
Disintegration Tester (Model: PTZ AUTO 3)
Growth Promotion and Inhibitory Test for Microbiological
47 QC/056/07 07 29.08.21 28.08.26
Media
48 Retrieval and Maintenance of Microorganisms QC/057/06 06 26.02.20 25.02.25
49 Microbial Contamination Test QC/059/09 09 18.06.23 17.06.28

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

44 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Quality Control Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date
50 Microbiological Assay of Antibiotics QC/060/05 05 05.07.19 04.07.24
Operation, Maintenance & Calibration of Incubator [Model No.
51 QC/061/05 05 01.12.19 30.11.24
INE 600]
52 Operation, Maintenance & Qualification of Autoclave Machine QC/062/06 06 25.06.23 24.06.28
[Model. No.Maintenance,
Operation, HV25] Cleaning & Qualification of Dry Heat
53 QC/063/05 05 02.01.20 01.02.25
Sterilizer
54 Operation, Cleaning and Maintenance of Microscope QC/064/05 05 28.11.20 27.11.25
Operation, Maintenance & Qualification of Laminar Air Flow
55 QC/065/06 06 31.07.19 30.07.24
Cabinet
Operation, Cleaning, Maintenance & Calibration of Cooled
56 QC/066/02 02 01.12.19 30.11.24
Incubator [Model no. ICP 500]
57 Operation, Cleaning and Maintenance of Vortex Mixture QC/067/05 05 06.11.20 05.11.25
58 Cleaning Procedure of Quality Control Laboratory QC/068/05 05 07.05.23 06.05.28
Operation, Cleaning ,Maintenance and Calibration of Vortex
59 QC/069/03 03 20.01.22 19.01.27
Mixture (Model No. VM-10 and VM-30)
60 Operation of Sterility Test Unit QC/070/06 06 07.05.23 06.05.28
61 Sterility Test QC/071/07 07 18.06.23 17.06.28
62 Bacterial Endotoxin Test QC/072/06 06 23.06.21 22.06.26
63 Bioburden Test QC/073/06 06 27.06.21 26.06.26
64 Bacterial Endotoxin Test Validation QC/074/04 04 20.01.22 19.01.27
65 Sampling of Water QC/075/08 08 21.05.23 20.05.28
Operation, Calibration & Maintenance of Agilent HPLC
66 QC/076/04 04 29.09.19 28.09.24
System [Model Agilent 1100 Series] Binary Gradient
Operation, Calibration & Maintenance of Flame Photometer
67 QC/077/04 04 16.10.19 15.10.24
[Model : 410]
Operation, Calibration & Maintenance of Liquid Particle
68 QC/078/04 04 08.04.19 07.04.24
Counter [Model : LiQuilaz E20]
69 Analytical Method Validation QC/079/04 04 14.10.19 13.10.24
70 Cleaning of Glassware use in QC Laboratory QC/080/05 05 06.02.23 05.02.28
71 Personnel Entry/Exit and Gowning for Sterility Test Room QC/082/04 04 29.12.19 28.12.24
72 Personnel Entry and Exit in Microbiology Laboratory QC/084/03 03 06.02.23 05.02.28
Operation, Calibration & Maintenance of Waters HPLC
73 QC/085/03 03 16.10.18 15.10.23
[alliance e2695]
Environment Monitoring of Hormone Product Manufacturing
74 QC/086/04 04 10.05.20 09.05.25
Area
75 Sampling of Pure Steam Condensate QC/087/04 04 14.02.22 13.02.27
Operation, Calibration & Maintenance of Shimadzu HPLC
76 QC/088/03 03 05.08.19 04.08.24
Instruments [Model: Prominence] Quaternary Gradient
77 Sample Receiving for QC Analysis QC/089/03 03 16.01.23 15.01.28

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

45 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Quality Control Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date
Operation,Calibration & Maintenance of Ultrasonic bath
78 QC/090/03 03 16.01.23 15.01.28
[ Hawsin,Korea, Model:Powersonic 520 ]
79 Efficacy Test of Disinfectant QC/091/03 03 06.02.23 05.02.28
Procedure for Settle Plate Preparation for Environment
80 QC/092/02 02 03.09.19 02.09.24
Monitoring
81 Operation and Cleaning of Dynamic Pass Box QC/093/02 02 01.09.19 31.08.24
Operation, Calibration & Maintenance of Shimadzu HPLC
82 QC/094/02 02 31.10.19 30.10.24
Instruments [Model : Prominence] Quaternary Gradient-2
Operation, Calibration & Maintenance of Agilent HPLC
83 QC/095/02 02 10.11.19 09.11.24
System [Model : Agilent 1260 Infinity] Quaternary Gradient
84 Operation and Cleaning of Anaerobic Jar QC/096/02 02 06.03.20 05.03.25
Operation, Qualification & Maintenance of Biological Safety
85 QC/098/02 02 07.05.23 06.05.28
Cabinet [Model No. AC2 - 5E1]
Operation, Maintenance & Qualification of Refrigerator
86 QC/100/01 01 21.08.18 20.08.23
[Model No. SJPE62 LH]
Operation, Calibration & Maintenance of Conductivity Meter
87 QC/101/01 01 12.08.18 11.08.23
(Model : S230]
Operation, Maintenance, Cleaning & Calibration of Portable
88 QC/102/03 03 16.04.23 15.04.28
Airborne Particle Counter (Model No. 9500-01)
Operation, Calibration & Maintenance of Agilent HPLC
89 QC/103/01 01 23.12.18 22.12.23
System [Model : Agilent 1260 Infinity] Binary Gradient
Operation, Calibration & Maintenance of Analytical Balance
90 QC/104/01 01 19.01.19 18.01.24
[Model : AS310.R2] Radwag
Operation, Calibration & Maintenance of Potentiometer with
91 QC/105/01 01 20.01.19 19.01.24
Karl Fisher Titratoe [Model : Titroline 7750]
Operation, Calibration & Maintenance of Shimadzu
92 UV - Visible Spectrophotometer QC/106/01 01 09.05.19 08.05.24
[Model : UV-1800]
93 Analyst Validation QC/107/01 01 11.03.19 10.03.24
94 Sterility Test Validation QC/108/02 02 17.07.21 16.07.26
95 Operation, Cleaning and Calibration of Micropipette QC/109/01 01 28.02.20 27.02.25
96 Bacterial Endotoxins Test by Kinetic-Turbidimetric Method QC/110/01 01 31.05.20 30.05.25
Operation, Cleaning, Maintenance and Qualification of
97 QC/111/01 01 31.05.20 30.05.25
Absorbance Microplate Reader
98 Personnel Hygiene Monitoring and Qualification QC/112/02 02 29.12.19 28.12.24
Operation, Calibration & Maintenance of Analytical Balance
99 QC/113/01 01 09.08.20 08.08.25
[Model : PA224] OHAUS, USA
Operation, Calibration & Maintenance of Shimadzu Total
100 QC/114/01 01 26.08.20 25.08.25
Organic Carbon Analyzer
Bacterial Endotoxins Test and Total Organic Carbon Test of
101 QC/115/01 01 20.09.20 19.09.25
WFI from Product Manufacturing Vessel

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

46 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Quality Control Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date
Operation, Calibration & Maintenance of Automatic
102 QC/116/01 01 23.09.20 22.09.25
Polarimeter [Model: ADP650]
Operation, Calibration & Maintenance of PerkinElmer Gas
103 QC/117/01 01 15.11.20 14.11.25
Chromatography [Model: Clarus 580]
Operation, Calibration & Maintenance of Shimadzu HPLC
104 QC/118/01 01 02.03.21 01.03.26
Instruments [Model: Prominence-i] Quaternary Gradient
Operation, Calibration & Maintenance of Laboratory Drying
105 QC/119/01 01 08.04.23 07.04.28
Oven [Model: Ecocell 111]
Operation, Calibration & Maintenance of Rotary Evaporator
106 QC/120/01 01 08.04.23 07.04.28
[Model: Hei-VAP Value]
Operation, Calibration & Maintenance of Mettler Toledo pH
107 QC/121/01 01 08.04.23 07.04.28
Meter [Model: SevenCompact S210]
Operation, Calibration & Maintenance of Melting Point
108 QC/122/01 01 07.04.23 06.04.28
Apparatus [Model: KSP1D]
Operation, Calibration & Maintenance of Muffle Furnace
109 QC/123/01 01 07.04.23 06.04.28
[Model: Nabertherm L5/13]
Operation, Qualification,Cleaning & Maintenance of
110 QC/124/01 01 08.05.23 07.05.28
Dissolution Tester [Model: PTWS D620]
111 Operation and Maintenance of Hand Dryer QC/125/01 01 05.06.23 04.06.28
112 Operation and Maintenance of IPA Dispenser QC/126/01 01 04.06.23 03.06.28
113 Antimicrobial Preservative Efficacy Test QC/127/00 00 12.09.18 11.09.23
Operation, Calibration & Maintenance of Memmert Vacuum
114 QC/128/00 00 22.09.18 21.09.23
Drying Oven [Model: VO 200]
Operation, Calibration & Maintenance of Malvern Particle
115 QC/129/00 00 24.09.18 23.09.23
Distribution Analyzer [Model:Mastersizer 3000]
Operation, Maintenance & Qualification of Refrigerator [Model
116 QC/130/01 01 16.02.23 15.02.28
No. SJPE62 LH-HS]
Operation, Calibration & Maintenance of Analytical Balance
117 QC/131/00 00 26.11.18 25.11.23
[Model : PB4002-S]
Operation, Qualification & Maintenance of Shimadzu IR
118 QC/132/00 00 31.12.18 30.12.23
Spectrophotometer Tracer-100 [Model : IRTracer-100]
Operation, Qualification & Maintenance of Potentiometer with
119 QC/133/00 00 05.02.19 04.02.24
Karl Fisher Titrator [Model:Titroline 7750]
Operation, Qualification & Maintenance of Liquid Particle
120 QC/134/01 01 06.03.23 05.03.28
Counter [Model: APSS-2000]
121 Analyst Validation For Microbiology Laboratory QC/136/00 00 25.03.19 24.03.24
122 Validation for Container-Closure System Integrity QC/137/00 00 30.03.19 29.03.24
Operation, Calibration & Maintenance of Shimadzu HPLC
123 Instruments Model: Prominence-I (LC-2030 Plus) Quaternary QC/138/00 00 24.04.19 23.04.24
Gradient with RID

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

47 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Quality Control Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date
Operation, Calibration & Maintenance of Shimadzu HPLC
124 Instruments Model: Prominence-I (LC-2030 Plus) Quaternary QC/139/00 00 21.04.19 20.04.24
Gradient
Operation, Calibration & Maintenance of Sartorius analytical
125 QC/140/00 00 14.07.19 13.07.24
balance Model:QUINTIX224-1S
Operation, Maintenance, Cleaning & Calibration of Active Air
126 QC/141/01 01 09.11.19 08.11.24
Sampler [Model No. SAS Super ISO 180]
Operation, Maintenance, Cleaning & Calibration of Analytical
127 QC/142/00 00 21.07.19 20.07.24
Balanceb [Model No. AS310.X2]
128 Identification and Purity Check of Microorganisms QC/143/00 00 30.07.19 29.07.24
Operation, Calibration & Maintenance of Shimadzu UV-
129 QC/144/00 00 22.09.19 21.09.24
Visible Spectrophotometer [Model :UV-1900]
Operation, Maintenance & Qualificatiion of Autoclave [Model
130 QC/145/00 00 25.09.19 24.09.24
No. HV110]
Operation Maintenance & Qualification of Vortex Mixture
131 QC/146/00 00 12.10.19 11.10.24
[Model No. MX-S]
Operation Maintenance & Qualification of Incubator [Model
132 QC/147/00 00 12.10.19 11.10.24
No. BD 400]
Operation, Calibration & Maintenance of Muffle Furnace
133 QC/148/00 00 28.10.19 27.10.24
[Model: Nabertherm LT 5/13]
Operation, Calibration & Maintenance of METTLER TOLEDO
134 QC/149/00 00 12.02.20 11.02.25
pH Meter [Model: Seven Compact S210]
Operation, Calibration & Maintenance of Shimadzu HPLC
135 QC/150/00 00 15.02.20 14.02.25
[Model: Prominence-I, LC-2030C]
Operation, Calibration & Maintenance of Oil Bath
136 QC/151/00 00 22.02.20 21.02.25
[Model: Memmert, ONE10]
Operation, Calibration & Maintenance of Shimadzu HPLC
137 QC/152/00 00 23.02.20 22.02.25
[Model: Prominence]
Operation, Calibration & Maintenance of Shimadzu Atomic
138 QC/153/00 00 24.02.20 23.02.25
Absorption Spectrophotometer [Model: AA-7000]
Operation, Calibration & Maintenance of Telendy Hanson
139 QC/154/00 00 21.09.20 20.09.25
Dissolution Tester [Model: CD 14]
140 Operation, Cleaning, Maintenance & Calibration of Incubator QC/155/00 00 21.11.20 20.11.25
Operation, Cleaning, Maintenance & Calibration of Cooled
141 QC/156/00 00 21.11.20 20.11.25
Incubator

142 Operation, Calibration & Maintenance of Shimadzu HPLC QC/157/00 00 02.03.21 01.03.26
Instruments [Model: LC-2030C 3D Plus] Quaternary Gradient
Total Viable Spore Count and Purity Check of Microorganism
143 QC/158/00 00 25.03.21 24.03.26
in Biological Indicator

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

48 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Quality Control Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date
Test for Objectionable Microorganism (Burkholderia cepacia
144 QC/159/00 00 29.08.21 28.08.26
Complex)
145 Rejection and disposal of HPLC Column QC/160/00 00 24.05.21 23.05.26
Out of Specification (OOS) and Out of Trend (OOT) Handling
146 QC/161/00 00 03.11.21 02.11.26
for Micribiological Test Result
147 HPLC Column Management QC/162/00 00 09.06.22 08.06.27
Operation, Qualification, Maintenane & Cleaning of ICP-MS
148 QC/163/00 00 24.07.22 23.07.27
[Model: NexION 1000]
Operation, Calibration, Maintenane & Cleaning of Anton Paar
149 QC/164/00 00 21.07.22 20.07.27
polarimeter (Model: MCP 5100)
Operation, Calibration, Maintenannce & Cleaning of Metrohm
150 QC/165/00 00 06.09.22 05.09.27
Conductivity Meter (Model: 912)
Operation, Qualification, Maintenane & Cleaning of Microwave
151 QC/166/00 00 17.10.22 16.10.27
Sample Preparation System (Titan-MPS)
Operation, Function Check, Cleaning and Maintenane of
152 QC/167/00 00 01.11.22 31.10.27
Karl-Fischer Titrator (Model : Metrohm Titrando 890)
Operation, Cleaning, Maintenance and Calibration of
153 QC/168/00 00 20.12.22 19.12.27
Sherwood Flame Photometer (425)
Operation, Calibration, Maintenance & Cleaning of Metrohm
154 QC/169/00 00 06.02.23 05.02.28
pH Meter (Model: 913)
155 Document Numbering System in Quality Control Department QC/170/00 00 06.02.23 05.02.28
156 Rounding off Analytical Test Results QC/171/00 00 02.02.23 01.02.28
157 Destruction of the Pharmaceutical Samples after analysis QC/172/00 00 09.03.23 08.03.28
Operation, Cleaning , Maintenance and Qualification of
158 Refrigerator [Model No.:SJ-EX735P-SL], used as stability QC/173/00 00 16.03.23 15.03.28
Chamber
Operation, Cleaning , Maintenance and Qualification of
159 QC/174/00 00 06.03.23 05.03.28
Laminar Air Flow cabinet [Model: LVG-3AG-F8]
Operation, Maintenannce,Cleaning & Calibration of Analytical
160 QC/175/00 00 15.03.23 14.03.28
Balance (Model: BCE 4202I-1S)
161 Handling of water test result failure QC/176/00 00 16.03.23 15.03.28
Operation, Cleaning , Maintenance and Qualification of
162 QC/177/00 00 16.03.23 15.03.28
Stability Chamber [Model No.:KBF 1020]
Operation, Cleaning , Maintenance and Qualification of Fume
163 QC/178/00 00 16.03.23 15.03.28
Cupboard [Model No.: OR-ST1200]
Operation, Cleaning, Qualification & Maintence of Agilent
164 QC/179/00 00 16.03.23 15.03.28
HPLC [Model: Agilent 1260 Infinity II] Binary Gradient

Prepared By: Checked By: Approved By:

Md. Shariful Alam Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

49 of 52
POPULAR PHARMACEUTICALS LTD.

SOP List

Quality Assurance Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

1 SOP on SOP QA/001/07 07 26.06.23 25.06.26

2 Batch Numbering System of Products QA/002/08 08 01.02.22 31.01.27
3 Assignment of Manufacturing and Expiration Date of Products QA/003/06 06 01.01.19 31.12.23

In-Process Control (IPC) for Oral Solid Dosage Forms

4 QA/004/04 04 07.07.19 06.07.24
(Tablet and Capsule)
Operation and Cleaning of Pharma Test Friability Tester
5 QA/007/05 05 15.06.19 14.06.24
[Model PTF 20E]
6 Visual Inspection of Coated Tablet QA/009/04 04 20.04.20 19.04.25
7 Rework QA/011/06 06 28.07.23 27.07.26
8 Deviation Reporting QA/012/06 06 09.04.19 08.04.24
9 Release/Rejection of Product QA/014/07 07 09.04.19 08.04.24
10 Approval of Materials from New Source QA/015/04 04 20.06.23 14.02.24
19.06.28
Time Limit for holding Materials, Intermediates and Bulk
11 QA/016/04 04 08.06.20 07.06.25
Products under Process
12 Change Control QA/017/06 06 29.12.20 28.12.25
13 Batch Records Compilation and Archiving QA/018/04 04 28.03.20 27.03.25
14 Batch Production Record Review and Reconciliation QA/019/04 04 28.03.20 27.03.25
15 Correction of Documentation Errors QA/020/05 05 18.11.19 17.11.24
16 Reprocessing and Repackaging QA/021/05 05 26.10.19 25.10.24
17 Product Complaint Handling QA/022/07 07 30.04.23 29.04.28
18 Product Recall QA/023/05 05 05.08.19 04.08.24
19 Line Clearance QA/024/04 04 22.09.20 21.09.25
20 Sampling of Products for QC Analysis QA/025/05 05 28.09.19 27.09.24
21 Self Inspection (Internal Quality Audit) QA/026/04 04 27.08.20 26.08.25
22 Issuance of Batch Production Records (BMR & BPR) QA/027/04 04 28.03.20 27.03.25
23 Handling of Retention Sample QA/029/04 04 28.11.18 27.11.23
24 Batch Failure Investigation QA/030/05 05 12.08.20 11.08.25
In-Process Control (IPC) for Liquid, Semi Solid and Powder
25 QA/031/04 04 05.05.20 04.05.25
for Suspension/Syrup/Injection
26 Basic Rules for Good Manufacturing Practice QA/034/05 05 01.11.20 31.10.25
27 Personnel Hygiene Practices QA/035/05 05 01.11.20 31.10.25
28 Document Control QA/036/05 05 24.05.21 23.05.26
29 Training of Quality Assurance Personnel QA/038/04 04 14.06.20 13.06.25
30 General Housekeeping QA/040/05 05 22.02.23 21.02.28
31 Employee Signature List QA/041/04 04 02.03.23 01.03.28
Operation, Calibration, Function Check and Cleaning of
32 QA/042/05 05 28.04.19 27.04.24
Analytical Balance Sartorius [Model CP323 S]

Prepared By: Checked By: Approved By:

Md. Shariful Aalm Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

50 of 52
Quality Assurance Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

Operation, Maintenance and Cleaning of Electrolab

33 QA/044/04 04 07.04.23 06.04.28
Disintegration Tester [ ED-2L ]
34 Annual Product Quality Review QA/045/05 05 16.04.23 15.04.28
35 Authorization and Disposal of Materials and Products QA/046/04 04 26.07.19 25.07.24
36 Vendor Audit QA/047/03 03 29.11.19 28.11.24
Corrective Action and Preventive Action (CAPA) and Tracking
37 QA/048/04 04 29.03.23 28.03.28
System
38 Technology Transfer from a Contarct Manufacturer QA/051/03 03 14.12.18 13.12.23
39 Handling of TSE Certificate QA/052/03 03 23.12.18 22.12.23
40 Refurbishing Returned/Damaged Finished Product QA/053/03 03 30.12.18 29.12.23
41 Process Validation QA/054/03 03 29.01.23 28.01.28
42 Long Term Stability Study QA/057/03 03 12.02.19 11.02.24
Operation, Maintenance and Cleaning of Electrolab Friability
43 QA/059/03 03 29.01.19 28.01.24
Tester [Model EF-2]
Operation, Maintenance and Cleaning of Electro Pharma Leak
44 QA/060/04 04 13.04.23 12.04.28
Test Apparatus [ Model LT-101 ]
45 Use and Control of Hand Sanitizer QA/064/03 03 18.07.19 17.07.24
Operation and Cleaning of Digital Thermo Hygrometer
46 QA/065/03 03 28.09.19 27.09.24
[ID. No.: PPL-DTH-QA-01]
47 Quality Risk Management QA/066/03 03 01.09.19 31.08.24
48 Inprocess Control for Packaging Operation QA/069/03 03 12.12.19 11.12.24
49 Control and Issuance of Logbooks QA/071/05 05 29.12.22 28.12.27
50 Cold Chain Management QA/072/03 03 30.12.20 29.12.25
51 Leak Test QA/073/02 02 13.04.23 12.04.28
Operation, Cleaning and Maintenance of Electrolab Leak Test
52 QA/076/03 03 13.04.23 12.04.28
Apparatus [ Model LT-101P ]
53 File Numbering System in QA Department QA/077/02 02 24.07.19 23.07.24
Operation, Cleaning and Maintenance of RADWAG Moisture
54 QA/079/02 02 12.07.20 11.07.25
Analyzer [MAC50/WH]
Operation, Maintenance and Cleaning of Pharma Test
55 QA/080/02 02 28.11.20 27.11.25
Hardness Tester [Model PTB 511 E]
Review of Documents and Release of Toll Manufacturing
56 QA/082/01 01 06.05.19 05.05.24
Product (Manufactured for PPL by GPL)
57 Media Fill Validation QA/083/02 02 02.04.19 01.04.24
Operation,Cleaning and Maintenance of RADWAG Moisture
58 QA/086/01 01 22.11.18 21.11.23
Analyzer [MA 50.R.WH]
Operation, Calibration, Function Check, Cleaning and
59 Maintenance of Analytical Balance RADWAG QA/088/01 01 13.12.18 12.12.23
[Model AS 310.R2]
Assignment of Manufacturing and Expiration Date of Toll
60 QA/089/01 01 01.01.19 31.12.23
Manufacturing Product (Manufactured by GPL)
61 Code Numbering System of Materials and Products QA/090/02 02 28.12.22 27.12.27

Prepared By: Checked By: Approved By:

Md. Shariful Aalm Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

51 of 52
Quality Assurance Department

Sl. Title SOP No. Revision Effective Review

No. No. Date Date

Operation,Cleaning and Maintenance of Logan Hardness

62 QA/094/01 01 07.10.20 06.10.25
Tester [HDT-400L]
63 Pharmacovigilance System QA/095/01 01 14.01.23 13.01.28
Operation, Calibration & Maintenance of Mettler Toledo pH
64 QA/096/01 01 20.11.20 19.11.25
Meter [ Model S220 & S210 ]
65 Sampling of Finished Products for QC Analysis QA/097/00 00 07.04.19 06.04.24
66 Validation of Computerized Systems QA/098/00 00 07.03.21 06.03.26
Operation and Cleaning of Portable Digital Tablet Hardness
67 QA/099/00 00 23.02.21 22.02.26
Tester [ Model HT-100TP ]
Operation and Cleaning of Electrolab Friability Tester [Model
68 QA/100/00 00 18.03.21 17.03.26
EF-2W]
Operation, Maintenance and Cleaning of Electrolab
69 QA/101/00 00 18.03.21 17.03.26
Disintegration Tester [ Model EDI-2 ]
Operation, Cleaning and Maintenance of Electrolab Leak Test
70 QA/102/00 00 18.03.21 17.03.26
Apparatus [ Model ELT-201 ]
Operation, Cleaning and Maintenance of COPLEY Hardness
71 QA/103/01 01 18.07.23 17.07.26
Tester [ Model TBF100i ]
Operation, Cleaning and Maintenance of OHAUS Moisture
72 QA/104/00 00 29.07.21 28.07.26
Analyzer [MB120]
73 Cleaning Validation QA/105/00 00 07.03.23 06.03.28
Operation, Cleaning and Maintenance of Electrolab Leak Test
74 QA/106/00 00 13.04.23 12.04.28
Apparatus [ Model LT-101P ]

Prepared By: Checked By: Approved By:

Md. Shariful Aalm Md. Shajidur Rahman Abu Shahed Ahmed

Senior Executive-QA Deputy Manager-QA Deputy General Manager-QA

52 of 52