Empa 10MG T-005

BRIELL Pharmaceuticals
BATCH MANUFACTURING RECORD
Tablet Section
Product Name: EMPA 10MG Tablet
1 Batch Number: T-005
3 Batch Size: 2000Tabs . .
4 Manufacturing Date: 05-2022 .
5 Expiry Date: 04-2024 .
6 Shelf Life: 24Months .
7 Pack Size: 2*7s .
8 Registration Number: -------- .
9 BMR Issued Date:. 09-05-2022
10 BMR Submission Date: 10-05-2022
Instruction:
1. Fill the BMR accurately, avoid cutting & overwriting. In case of any mistake/ error, cut that word or line with a single stroke and do initials there.
2. Check the materials for their identity (by name, Batch no and Release status) and quantity.
3. Ensure line clearance prior to start of each process.
4. Ensure compliance of environmental conditions (Temperature, Relative Humidity and Differential Pressure) during all manufacturing operations whenever necessary.
5. Use mask, Gloves, cap and uniform during process. (As per requirement)
6. Do not touch any moving parts of the machine while in operation. Use all the electrical board/panel carefully and keep away from any spillage.
7. Strictly follow all the steps of standard operating procedures.
8. Make sure all safety guards and side panels are in position before and after starting machine.
9. In case of any deviation, immediately inform and get permission from senior corrective and preventive action and document all the deviations.
10. Product Status of all the steps of manufacturing and packing operations must be displayed.
Note: All the equipment and utensils must be properly cleaned and properly labeled.
Reviewed By: ____________________ Approved By:________________

Section Incharge QA Officer
CONTROLLED COPY: NO COPYING WITHOUT MANAGER Q.A PERMISSION

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RED STAMP INDICATES ORIGIONAL DOCUMENT
Page 1 of 48
BRIELL PHARMACEUTICALS Production Dept.
Product Code: Doc no: R&D/BMR/001

PRODUCT NAME: EMPA 10MG TABLET Revision no: 00
Reg NO: ------- BATCH NO:T-005 Batch Size: 2000Tab Mfg.: 05-2022 Exp.: 04-2024 Revision date:01-02-2022
Prepared By Verfied By Approved By Authorized By
Production Incharge Quality Control Incharge Quality Assurance Incharge Director Operations
BMR COMPLIANCE CHECKLIST

Availability of Availability of
Documents and Page Sr. Documents and Page
Sr. # TABLE OF CONTENTS Compliance TABLE OF CONTENTS Compliance
No. # No.
Yes  √ No  x Yes  √ No x
1. Cover page & General Instructions 01 24 Equipment Cleaning Status 27
2. BMR Compliance Checklist 02 25 Standard Manufacturing Procedure for Coating 28
3. Master Formulation 03 26 Weight Record of Coated Tablets & Yield Calculation 29
4. Calculation of API 04 27 Quality Control Testing Report After Coating 30
5. Manufacturing Order 05-06 28 Packing Order 31-32
6. Line Clearance Checklist for Dispensing 07 29 Line Clearance Checklist for Blistering 33
7. Verification of Dispensed Raw Materials 08 30 Equipment Cleaning Status & Embossing Information 34
List of Equipment Used During Manufacturing & Packing 35
8. 09 31 Line Clearance Checklist for Blistering P/S
Process
9. Line Clearance Checklist for Granulation 10 32 Equipment Cleaning Status & Embossing Information P/S 36
10. Standard Manufacturing Procedure for Granulation 11-13 33 In process Control sheet for Blistering 37
11. Quality Control Testing Report (Moisture contents) 14 34 Team Layout Sheet at Blistering Stage 38
12. Granulation Procedure (Final Mixing) 15 35 Line Clearance Checklist for Printing Machine & Area 39
13. Weight Record of Grains & Yield Calculation 16 36 Over Printing Information 40-41
14. Quality Control Testing Report at Final Mixing Stage 17 37 In process Control SHEET for Printing 42
15. Line Clearance Checklist for Compression 18 38 Team Layout Sheet at Printing Stage 43
16. Equipment Cleaning Status & Product Specification 19 39 Line Clearance Checklist for Packing 44
17. Compression Start Up Analysis Sheet 20 40 Team Layout Sheet at Packing Stage 45
18. Weight Control Sheet for Compression 21 41 In process Control SHEET for Packing 46
19. In process Weight Monitoring Sheet 22 42 Certificate of Analysis 47
20. In process Control Sheet for Compression 23 43 Finished Goods Transfer Note 48-49
21. Weight Record of Compressed Tablet & Yield Calculation 24 44 Packing Material Reconciliation 50
22. Quality Control Testing Report After Compression 25 45 Batch Reconciliation 51
23. Line Clearance Checklist for Coating 26 46 Destruction Note 52
All the above documentsSTAMP
are checked and found satisfactory. Checked By: _______________ Reviewed By: ____________
Section In charge QA Officer
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Page 2 of 48

MASTER FORMULATION FOR RAW MATERIAL
Each Tablet Standard Batch

Sr. # Raw Materials
Contains (mg) Size (2000Tablets.)
1. Empagliflozin 10.00mg 20.00gm
2. Lactose monohydrate 95.238mg 190.476gm
3. Starch 50.855mg 101.71gm
4. PVP K 30 4.30mg 8.60gm
5. Primojel 2.00mg 4.00gm
6. Purified Water 0.05ml 100ml
7. Magnesium stearate 5.11mg 10.22gm
8. Avicel-102 41.10mg 82.20gm
9. Aerosil-200 1.50mg 3.00gm
10. Coat Dry White 11.00mg 22.00gm
11. IPA 0.176ml 352ml
12. Titanium Dioxide 2.20mg 4.40gm
13. PEG 6000 2.20mg 4.40gm
14. RO Water 0.044ml 88.00ml

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Page 3 of 48

CALCULATION OF ACTIVE PHARMACEUTICAL INGREDIENT (API)
API Empagliflozin................10 mg
Each film coated tablet contains:
Label Claim Empagliflozin.......... 10mg
(Innovator’s Specifications)
Assay of API (Potency): 99.60% (as such)
Overage of API: _______________________
Label Claim: 10mg per Tablet
Weight of API per tablet( mg) = 100_ x Label Claim = 10.04mg/Tablet

Assay of API (potency)
Weight of API per batch(kg) = mg/Tablet x batch size = 20.08 g/batch size
1000g
Total Weight of API (g): __________20.08g________________________
Remarks (if any): __________________________________________

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Calculated By:_______________Checked By: ____________Verified By: ___________ Approved By: ____________ Section Incharge
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Production Manager QC Manager QA Manager
Page 4 of 48

MANUFACTURING ORDER For Production Use

Date: _____________
Product Name: EMPA 10MG Tablet Batch No: T-005
Manufacturing Date: 05-2022 Expiry Date: 04-2024
Batch Size (Kg): 420.246gm Batch Quantity: 2000Tab
Registration No: ----- Shelf Life : 24months
Section: General Tablet Section
Checked Received By
Qty. Additional Qty Dispensed Verified
QC. No Raw Materials Qty. Issued Return Actual Used By Disp.
By QA Officer
Production
Reqd. Issued By Pharmacist Pharmacist
Empagliflozin
20.00 gm 20.04 gm
Lactose monohydrate 190.47 gm 190.47 gm
Starch 101.71gm 101.71gm
PVP K 30 8.60 gm 8.6 gm
Primojel 4.00 gm 4.00 gm
Magnesium stearate 10.22 gm 10.22 gm
Avicel-102 82.20 gm 82.20 gm
Aerosil-200 3.00 gm 3.00 gm
Coating Material Dispensing
Checked Received By
Qty. Additional Dispensed Verified
By QA Officer
Production
Reqd. Qty Issued By Pharmacist Pharmacist
Coat Dry White 21.00gm 21.00gm

IPA 352.0ml 352.0ml
Titanium Dioxide 4.40gm 4.40gm
PEG 6000 4.40gm 4.40gm
RO Water 88.00ml 88.00ml
MANUFACTURING ORDER For Warehouse Use
Date: _____________ CONTROLLED COPY: NO COPYING WITHOUT MANAGER Q.A PERMISSION
Product Name: Calculated
STAMP By:_________________
CONTROLLED COPY: EMPA NO10MG Checked
COPYING
By: ____________________
TabletWITHOUT MANAGER Q.ABatch
Verified By: ________________ Approved by:
No:
PERMISSION
_________
T-005
Manufacturing Date: Section 05-2022
Incharge Production Manager Expiry Date: QC Manager QA manager
04-2024
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Batch Size (Kg): 420.246gm Batch Quantity: 2000Tab
Page 5 of 48

Registration No: --------- Shelf Life : 24 Months

Section: General Tablet Section
Checked Received By
Qty. Additional Qty Dispensed Verified
By QA Officer
Production
Reqd. Issued By Pharmacist Pharmacist
Empagliflozin
20.00 gm 20.04 gm
Lactose monohydrate 190.47 gm 190.47 gm
Starch 101.71gm 101.71gm
PVP K 30 8.60 gm 8.60 gm
Primojel 4.00 gm 4.00 gm
Magnesium stearate 10.22 gm 10.22 gm
Avicel-102 82.20 gm 82.20 gm
Aerosil-200 3.00 gm 3.00 gm
Coating Material Dispensing
Checked Received By
Qty. Additional Dispensed Verified
By QA Officer
Production
Reqd. Qty Issued By Pharmacist Pharmacist
Coat Dry White 21.00gm 21.00gm

IPA 352.0ml 352.0ml
Titanium Dioxide 4.40gm 4.40gm
PEG 6000 4.40gm 4.40gm
RO Water 88.00ml 88.00ml
LINE CLEARANCE CHECKLIST FOR DISPENSING
DISP. OFFICER QA OFFICER
Sr. # Calculated By:_________________ Checked By: ____________________
CLEARANCE PARAMETERS Verified By: ________________ Approved by: _________
Yes No Yes No
Section Incharge Production Manager QC Manager QA manager
01 Is area properly cleaned and labeled?    
02 Are there any traces of previous Product _________________Batch # ____________in    
a- Area, Equipment, Tools, Containers, Pallets    
b- CONTROLLED
Dispensing Hood COPY: NO COPYING WITHOUT MANAGER Q.A PERMISSION    
c- STAMP
Platform Weighing balance
CONTROLLED COPY: NO COPYING WITHOUT MANAGER Q.A PERMISSION    
d- TopRED STAMPWeighing balance
Loading    
STAMP INDICATES ORIGIONAL DOCUMENT
STARTUP PARAMETERS
Page 6 of 48

03 Are equipment & containers properly cleaned & labeled with Equipment / Product Identification Label?    
04 Are Personnel in the dispensing room wearing specified cleaned uniform, gloves and mask?    
Is Temperature and relative humidity in accordance with the requirements and recorded?
05    
Temperature:_______(°C) & Humidity:_________(%)
06 Are log books maintained properly?    
07 Are weighing balances in calibrated status?    
08 Is Differential Pressure in accordance with the requirements and recorded?    
09 Is dispensing hood properly in working condition?    
10 Are all dispensing tools used in dispensing, properly cleaned and wrapped in polythene bag having cleaned status?    
11 Are Raw materials to be dispensed having proper identification label and QC release?    
12 Is approved manufacturing order pertaining to the batch to be dispensed, available and as per requiBlack batch size?    
13 Are Dispensing tags available as per manufacturing order?    
All the above parameters are checked and found satisfactory
PRODUCTION PHARMACIST _______________ DATE & TIME:_______________ LINE CLEARANCE AWARDED: YES □ NO □
QA OFFICER ___________________ DATE & TIME:________________ REMARKS: _______________________
LINE CLEARANCE FOR MORE THAN ONE TIME AFTER RECHECKING OF ABOVE PARAMETERS EACH TIME
DATE TIME LINE CLEARANCE STATUS CHECKED BY RECHECKED BY IPQC
VERIFICATION OF DISPENSED RAW MATERIALS

All the Dispensed Raw Material Identification Slips Are Attached Here

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Page 7 of 48

1. All belongings of the previous product/ Material are

All the above dispensed materials are checked and received as per Manufacturing order.
Checked by: ___________________ Verified by: ___________________

Production Pharmacist QA Officer
LIST OF EQUIPMENT USED DURING MANUFACTURING

AND PACKING PROCESS and CLEANING STATUS
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Page 8 of 48

Sr. Equipment ID
Description Cleaning Status
#
Sigma Mixer BM/R&D/001
1
Rotary wet granulator BM/R&D/002
2
Powder tray dryer BM/R&D/003
3
Oscillating Dry granulator BM/R&D/004
4
5 Double cone mixer BM/R&D/005
6 Rotary tablet press ZP-17 BM/R&D/006
7 Dust collector -----
8 Double jacket coating mixer BM/R&D/007
9 Coating pan SS BM/R&D/008
10 ALU-ALU blister machine 4001
11 LASER Jet printer 4003
12 Conveyer belt 4002
All the above mentioned equipment are checked and found in proper working condition.
Checked By: ___________________ Verified By: ______________

Production Pharmacist QA Officer

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Page 9 of 48
BRIELL PHARMACEUTICALS R&D Dept.
Product Code: ------ Doc no: RD/BMR/001

PRODUCT NAME: EMPA 10MG TABLET
Revision no:00
Reg NO: ----- BATCH NO: T-005 Batch Size: 2000tab Mfg.: 05-2022 Exp.: 04-2024 Revision date: 01-02-2022
Production Incharge Quality Control Incharge Quality Assurance Incharge Plant manager
LINE CLEARANCE CHECKLIST FOR GRANULATION

PRD OFFICER QA OFFICER
Sr.# CLEARANCE PARAMETERS
Yes No Yes No
02 Are there any traces of previous Product ______________Batch #___________in    
a- Area, Containers, Equipment & Measuring Tools    
b- Mechanical Sifter    
c- Mixer Granulator    
d- Platform Weighing Balance    
START UP OPERATION
03 Are equipments & containers properly labeled with Equipment / Product Identification Label?    
04 Are personnel in the granulation area wearing specified clean uniform, gloves and masks?    
06 Is weighing balance calibrated?    
Is Temperature and relative humidity in accordance with the requirements and recorded?
07    
08 Is Differential Pressure in accordance with the requirements and recorded?    
09 Are dispensed raw materials pertaining to respective batch available?    
10 Is documentation of previous stages completed?    
All the above parameters are checked and found satisfactory.
PRODUCTION PHARMACIST _______________ DATE & TIME:_______________ Line Clearance awarded: YES □ NO □
QA OFFICER ___________________ DATE & TIME:________________ REMARKS: _______________________
LINE clearance for more than one time after rechecking of above parameters each time
Date Time Line clearance status Checked by Rechecked by IPQC
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Page 10 of 48

Revision no:00
STANDARD MANUFACTURING PROCEDURE FOR GRANULATION

Performed Checked By Verified
Step
GRANULATION PROCEDURE By Production By QA
#
Operator Pharmacist Officer
1 DRY MIXING:
Sr.# Ingredients Actual Wt. (Kg)
1 Lactose Monohydrate
2. Starch
Sieve materials through mesh # 12. Transfer the above sieved material to mixer.
Mix the above material for 15 to 20 minutes.
Mixing Started at: ____________ Mixing Completed at: __________
Total Mixing Time: ___________ Date:__________
2 BINDER SOLUTION PREPARATION:

1. PVP K 30
2. Purified Water
Dissolve starch in small portion of purified water at room tempaerature. Than add this mix in remaining quantity of warm
purified water in which PVP K 30 is already dissolved. Heat till binder solution is prepared. Allow the solution to cool at
room temperature before application.

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Page 11 of 48

Revision no:00

Step GRANULATION PROCEDURE By Production By QA
# Operator Pharmacist Officer
3 WET MIXING:
Now add binder solution into mixer & wet the previously sieved material present in mixer. Run the mixer for 10 minutes.
Wet mixing started at:________ Wet mixing completed at:________
Total wet mixing Time: ________ Date:__________
WET GRANULATION:
Pass the wet material through rotary granulator to obtain grains which are then spread into trays for drying.
4
Wet granulation started at:________ Wet granulation completed at:________
Total wet granulation Time: ________ Date:__________
DRYING:
5 After wet granulation transfer the granulated material to Tray Dryer and dry the material at 70°C.
Drying Started at: _________ Drying Completed at: _________
Total Drying Time: ________ Date:__________
Send request to QA for sampling after complete drying of grains for the checking of Moisture contents which should be
NMT 5 %.
Sampled Quantity: ______________ gm

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Page 12 of 48

Revision no:00

Step GRANULATION PROCEDURE By Production By QA
6 SIEVING :
After drying, fix _____ # mesh on oscillating granulator and pass the dried material through it. Collect the grains in
polythene lined labeled containers.
Sieving Started at: _________ Sieving Completed at: _________
Total Sieving Time: ________ Date:__________

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QUALITY CONTROL TESTING REPORT (MOISTURE CONTENT)
Page 13 of 48

Revision no:00
Filled By Production
Date: Time: Section: Stage: Section Incharge (Sign)
General Tablet Section After Drying
Filled By Quality Assurance
Date: Time: Sampled By: Quantity: QA Officer (Sign)
Analysis Report (Filled By QC)

Sample Receiving Sample Receiving Sample Release Sample Release Time: QC Reference
Date: Time: Date: No.
Tests Specifications Results

Loss on Drying NMT 5.0 %
Remarks: _________________________________________________________________________
Performed By: ______________ Checked by: _________________ Approved by: ______________

QC Analyst Asst. QC Manager QC Manager

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Page 14 of 48

Revision no:00

Step # GRANULATION PROCEDURE By Production By QA
Operator Pharmacist Officer
5 FINAL MIXING:
1. Empagliflozin
2. Avicel-102
3. Primojel
Pass material 1&2 through mesh # 16 and transfer into double cone mixer for final mixing. Run the mixer for 25-30 minutes.
6 Mixing Started at: _________ Mixing Completed at: _________
Total Mixing Time: ________ Date:__________
LUBRICATION:
1. Mg. Stearate
2. Aerosil-200
Pass Magnesium Stearate through mesh #30 and transfer into double cone mixer for mixing. Run the mixer for 2-5
minutes.
Mixing Started at: _________ Mixing Completed at: _________
Total Mixing Time: ________ Date:__________

Discharge the material from cone mixer through butterfly valve in the tarred containers equipped with clean
polythene bags. Send requestCOPY:
CONTROLLED to QANO
forCOPYING
samplingWITHOUT
after finalMANAGER
mixing. Q.A PERMISSION
STAMP
Sampled Quantity: ______________
CONTROLLED COPY: NOgmCOPYING WITHOUT MANAGER Q.A PERMISSION
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Page 15 of 48

Revision no:00
WEIGHT RECORD OF GRAINS & YIELD CALCULATION

Date: ______________
Container Performed By Checked By Production Verified By QA
Gross Weight (Kg) Tare Weight (Kg) Net Weight (Kg)
Number Operator Pharmacist Officer
1
2
3
TOTAL NET WEIGHT _________________Kg.
Theoretical weight of Grains =___________ Kg

Actual weight of Grains =_______________ Kg
% Yield = __________________________ %
Wastage = ____________________________%
Note: Store the grains with proper Air tight Polythene bags in labeled containers in in-process Quarantine Area.
Performed by: ___________Checked by: ________________ Verified by: ____________

Operator Production Pharmacist QA Officer
Transfer Of Grains from In-process Quarantine Area to Compression Section:
Total Weight received: _______________ Date: _________________________

Recieved by: ______________________
STAMP Checked by: ___________________
STAMPOperator Production Pharmacist
QUALITY CONTROL TESTING REPORT AT FINAL MIXING STAGE
Page 16 of 48

Revision no:00
General Tablet Section Final mixing

Sample Receiving Date: Sample Receiving Time: Sample Release Date: Sample Release Time: QC Reference No.

Physical Appearance White to Off White Color Granular Powder
Identification:
Loss on Drying NMT 5%
Assay: 90-110% as label claim of Empagliflozin
Proposed weight: Compression Range:
Remarks: _________________________________________________________________________
Performed By: ______________ Checked by: _________________ Approved by: ______________

QC Analyst Asst. QC Manager QC Manager

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Page 17 of 48

Revision no:00
LINE CLEARANCE CHECKLIST FOR COMPRESSION

Sr.# PRD OFFICER QA OFFICER
CLEARANCE PARAMETERS Yes No Yes No
02 Are there any traces of previous Product _____________ Batch #_________ in    
a- Area, Containers, Machine Tools.    
b- Tablet Compression Machine    
c- Top Loading Weighing Balance    
START UP OPERATION
04 Are personnel in compression area wearing specified cleaned uniform, gloves and mask?    
05 QC release of the batch to be processed is present?    
07 Is balance in calibrated status?    
Is Temperature And relative humidity in accordance to the requirements and recorded?
08
   
09 Is Differential Pressure in accordance to the requirements and recorded?    
PRODUCTION PHARMACIST:_______________ DATE & TIME:_______________ Line Clearance awarded: YES □ NO □
QA OFFICER:_____________________ DATE & TIME:________________ REMARKS: ___________________________________
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PRODUCT SPECIFICATIONS (CORE TABLETS)
Page 18 of 48

Revision no:00
Physical Appearance: White Colored One Side Engraved Cut line Round Tablet
Punch Shape: Round
Punch size: 8 mm
Average weight: 210mg / tablet
Weight variation Limit: ± 7.5 %
Range: 194.25-225.75mg
Diameter: 8±0.04mm
Thickness: 5±0.04mm
Hardness: NMT 10 kg
Disintegration time: NMT 15 mint
Friability: NMT 1 %
Punches, Dies and Tablets verification:
Dies & Punches should be checked for proper fitting. Tablets of first round checked by Production Pharmacist (all physical parameters except disintegration) and after
machine adjustment Production pharmacist will send intimation to concerned QA Officer to collect sample for physical analysis such as Appearance, Diameter, Thickness,
Hardness, Friability, Average Wt., Disintegration Time, and Wt. Variation of tablets.

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STAMP COMPRESSION START UP ANALYSIS SHEET
Page 19 of 48

Revision no:00
General Tablet Section Compression
Date: Time: Sampled By Quantity QA Officer (Sign)
Average Weight: Range:

Sr. # Wt. / Tablet (mg) Sr. # Wt. / Tablet (mg) Sr. # Wt. / Tablet (mg) Sr. # Wt. / Tablet (mg)
1 6 11 16
2 7 12 17
3 8 13 18
4 9 14 19
5 10 15 20
Avg. Wt. / 20 Tablets :
Hardness:
Disintegration Time :
Friability :
Diameter:
Thickness:
Remarks ( if any ) :
QC Analyst _______________________ QC Manger __________________

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IN-PROCESS
RED STAMP INDICATES ORIGIONAL DOCUMENT WEIGHT MONITORING SHEET
Page 20 of 48

Revision no:00
Date: ___________ Start Time: ____________ Close Time: ___________

Proposed weight: Lower Limit : Upper Limit:
Date
Sr.#
Time
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Avg. Wt.
Production Officer ________________ QA Officer : ________________

Note: 1) QA officer will use Black ball point.COPY:
CONTROLLED 2) InNO
process entries are
COPYING taken every
WITHOUT 45 minutesQ.A
MANAGER by QA and production alternatively.
PERMISSION
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INPROCESS CONTROLSHEET FOR COMPRESSION
Page 21 of 48

Revision no:00
S. No Time Disintegration Friability Hardness Length/ Thickness Color of Checked By

Time Diameter Tablet
Checked by: __________________ Verified by: ____________

Production Officer QA Officer

STAMP WEIGHT RECORD OF COMPRESSED TABLET
& YIELD CALCULATION
STAMP
Page 22 of 48

Revision no:00
Date: ______________
Container Tare Weight Net Weight Checked By Production Verified By QA
Gross Weight (Kg) Performed By Operator
Number (Kg) (Kg) Pharmacist Officer
1
4
Theoretical weight of grains:_____________ Kg Actual weight of compressed tablets:___________ Kg
% Yield = _________________ % % Wastage = ________________%

Note: Store the core tablets in proper Air tight Polythene bags, in labeled containers, in in-process Quarantine Area
Performed by: ____________ Checked by: __________________ Verified by: ____________

Transfer Of Compressed Tablets to Coating Section:
Total Weight received: _______________ Date: __________________________
Performed by: _____________________ Checked by: ____________________

Operator Production Pharmacist
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QUALITY CONTROL TESTING REPORT AFTER COMPRESSION
Page 23 of 48

Revision no:00
General Tablet Section Compression


Sample Receiving Date: Sample Receiving Time: Sample Release Date: Sample Release Time: QC Reference No.

Physical Appearance White Color Round Shape Core Tablet with engraved cut line on one side
Identification:
Average weight/Tablet 210mg/Tablet±7.5%
Diameter 8±0.04mm
Thickness 5±0.04mm
Hardness NMT 10 kg
Friability NMT 1 %
Disintegration Time NMT 15mint
Assay: 90-110% of the label claim of Empagliflozin
LINE CLEARANCE CHECKLIST FOR COATING

Performed By: ______________ Checked by: ________________ Approved by: ______________

QC Analyst
CONTROLLED Asst. Manager
COPY: NO COPYING WITHOUT MANAGERQC
Q.A PERMISSION QC Manager
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Page 24 of 48

Revision no:00
Yes No Yes No
Sr. # CLEARANCE PARAMETERS
02 Are there any traces of previous Product _______________ Batch #_________ in    
a- Area, Containers, Stools, S.S bowl    
b- Conventional Coating Pan    
START UP OPERATION
04 Are personnel in the blistering room wearing specified clean uniform, gloves and mask?    
06 Is coating machine specific parts (gauges) in calibration status?    
Are Temperature and relative humidity in accordance to the requirements and recorded?
07 Temperature:_______(°C) & Humidity:_________(%)
   
PRODUCTION PHARMACIST: _____________ DATE & TIME:_______________ Line Clearance awarded: YES □ NO □
QA OFFICER: _________________ DATE & TIME:________________ REMARKS: _________________________________

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Page 25 of 48

Revision no:00
STANDARD COATING PROCEDURE (FILM COATING)

Step
COATING PROCEDURE By Production By QA
COATING SOLUTION PREPARATION:
1. Sr Ingredients Actual Wt. Sr. Ingredients Actual Wt.
1. 4.
Coat Dry Titanium Dioxide
.
2. IPA 5. PEG 6000
3. Water
Take IPA & add the above mentioned materials in it and mix for 45 minutes.
Mixing started at: ____________ Mixing completed at: _________
Total Mixing Time : _________ Date:__________ Filter the coating solution through appropriate filters.
COATING:
Dedust the core tablets before loading into the pan. Load the core tablet in the Coating pan using SS Bowl. Switch ON the
main power supply & warm the cores for 5 minutes.
Spray the coating solution on tablet bed till all the solution is used. Adjust and maintain the following parameters during
coating.
Coating started at: ____________ Coating completed at: _________
Total Coating Time : _________ Date:__________
After complete coating, transfer the coated tablets from coating pan in the tarred containers equipped with clean polythene
bags. Send request to QA for sampling for physical and chemical analysis & calculate %age weight gain & %age yield.

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Page 26 of 48

Revision no:00
WEIGHT RECORD OF COATED TABLETS & YIELD CALCULATION

Date: ______________
Checked By
Container Tare Weight Net Weight Performed By Verified By QA
Gross Weight (Kg) Production
Number (Kg) (Kg) Operator Officer
Pharmacist
1
2
3
4
Theoratical Weight:_________ kg Actual weight of coated tablet:____________ Kg
% Yield = _________________ % % Wastage = ________________%
Note: Store the coated tablets in proper Air tight Polythene bags, in labeled containers, in in-process Quarantine Area
Performed by: ____________ Checked by: __________________ Verified by: ____________

Transfer Of Coated Tablets to Blistering Section:
Total Weight received: _______________ Date: __________________________

STAMP
Performed by: _____________________
STAMP Checked by: ____________________
Page 27 of 48

Revision no:00
Operator Packing Pharmacist

QUALITY CONTROL TESTING REPORT AFTER COATING
Date:
Time: Section: Stage: Section Incharge (Sign)
General Tablet Section Coating
QA Officer
Date: Time: Sampled By: Quantity:
(Sign)

Sample Receiving Sample Receiving Sample Release Sample Release QC Reference
Date: Time: Date: Time: No.

Physical Appearance White Color Round Shape Coated Tablet with engraved cut line on one side
Identification:
Diameter 8±0.04mm
Thickness 5±0.04mm
Hardness NMT 10 kg
Friability NMT 1 %
Remarks: _______________________________________________________________________________

STAMP
PACKING ORDER
Performed By: ______________
STAMP Checked by: ________________ Approved by: ______________
QC Analyst Asst. Q.C. Manager
RED STAMP INDICATES ORIGIONAL DOCUMENT Q.C.
Page 28 of 48

Revision no:00
Date: ______________
Mfg. Date: 05-2022 Expiry Date: 04-2024
Batch Size: 420.246gm Batch Quantity: 2000tab
Product Reg. No: ----- Shelf Life: 24months
Section: General Tablet Section Memo: Trail
Actual Checked By Received By

Quantity Qty. Additional Verified
QC. No Packaging Material Return Quantity Wastage Warehouse Packing
Required Issued Qty. By QA Officer
Used Officer Pharmacist
Aluminium foil 01.30 kg 01.30 kg
Alu- Alu Base foil
6.66 kg 6.66 kg
(260mm)
Unit Cartons 200No’s 200No’s
Leaflet 200No’s 200No’s
Shipers 1.00 No’s 1.00 No’s
Transparent tape
1.00 No’s 1.00 No’s
Prepared By: __________ Reviewed By:______________ Verified By: ____________ Approved By: ___________
Section Incharge Production Manager Store Incharge QC Manager

STAMP
PACKING ORDER
Date: ______________ STAMP
Page 29 of 48

Revision no:00
Mfg. Date: 05-2022 Expiry Date: 04-2024

Batch Size: 420.246gm Batch Quantity: 2000tab
Product Reg. No: ------ Shelf Life: 24Months
Section: General Tablet Section Memo: Trail
Actual Checked By Received By

Quantity Qty. Additional Verified
QC. No Packaging Material Return Quantity Wastage Warehouse Packing
Required Issued Qty. By QA Officer
Used Officer Pharmacist
Aluminium foil 01.30 kg 01.30 kg
Alu- Alu Base foil
6.66 kg 6.66 kg
(260mm)
Unit Cartons 200No’s 200No’s
Leaflet 200No’s 200No’s
Shipers 1.00 No’s 1.00 No’s
Transparent tape
1.00 No’s 1.00 No’s
Prepared By: __________ Reviewed By:______________ Verified By: ____________ Approved By: ___________
Section Incharge Production Manager Store Incharge QC Manager
LINE CLEARANCE CHECKLIST FOR BLISTERING

CONTROLLED COPY: NO COPYING WITHOUT MANAGER Q.A PERMISSION PRD OFFICER QA OFFICER
Sr. # STAMP CLEARANCE PARAMETERS Yes No Yes No
01 Is area properlyRED
cleaned
STAMP and labeled?
   
Page 30 of 48

Revision no:00
02 Are there any traces of previous Product _______________ Batch #________ in    

a- Area, Conveyer Belt, Trays, Containers, Stools, S.S bowl    
b- Automatic Blister Machine    
START UP OPERATION
04 Are personnel in the blistering room wearing specified clean uniform, gloves and mask?    
06 Is blistering machine specific parts (gauges) in calibration status?    
07
   
08 Is QC released packaging material to be used for respective batch available?    
09 Correct Embossing of Batch no. & Expiry date on Blisters.    
PRODUCTION PHARMACIST: ___________ DATE & TIME:_______________ Line Clearance awarded: YES □ NO □
QA OFFICER : _____________ DATE & TIME:________________ REMARKS: _________________________________
EMBOSSING INFORMATION
Batch No.& Expiry Date
STAMP
T-005 EXP 04-2024
STAMP
Attach Verified Embossed Empty Blister Specimen Here
RED
Attach First STAMP INDICATES ORIGIONAL DOCUMENT
Blister Attach Second Blister Attach Third Blister
Page 31 of 48

Revision no:00
Performed By: ____________ Checked By: ___________________ Verified By: ___________

IN-PROCESS CONTROL SHEET FOR BLISTERING OF TABLETS
Date: _____________Start Time: ____________Close

CONTROLLED Time: ___________
COPY: NO COPYING WITHOUT MANAGER Q.A PERMISSION Status
STAMP YES
: ✔ NO : X
Checking Parameters
Date Time STAMP Checked by Remarks
Embossing Blisters Foil Status
Page 32 of 48

Revision no:00
Bulk inspection of
Batch No. Exp. Date Leakage Test Cutting Text Printing
product
REMARKS: ________________________________________________________________________________
Production Pharmacist________________ QA Officer: ________________
Note: 1) QA officer will use Black ball point while Production officer will use Blue ball point.
2) In process entries are taken every 30 minutes by QA and production alternatively.
TEAM LAY OUT SHEET AT BLISTERING STAGE
Start
CONTROLLED Time:NO COPYING WITHOUT MANAGER Q.A PERMISSION
COPY: Close Time:
STAMP Start Date: Close Date:
STAMP
Page 33 of 48

Revision no:00
Name Time In Time Out Total Time
Performed By: ____________ Checked By: ____________________

Operator Production Pharmacist
LINE CLEARANCE CHECKLIST FOR PRINTING

Sr. # CLEARANCE PARAMETERS Yes No Yes No
01 Is area properly cleaned andlabeled?
CONTROLLED COPY: NO COPYING WITHOUT MANAGER Q.A PERMISSION    
STAMP
02 Are there any traces of previousCOPY:
CONTROLLED NO_______________
Product COPYING WITHOUT MANAGER
Batch Q.A PERMISSION
#________ in    
STAMP
a- RED STAMP INDICATES
Area, Conveyer Belt ORIGIONAL DOCUMENT    
Page 34 of 48

Revision no:00
START UP OPERATION
03 Are equipment & containers properly cleaned &labeled withEquipment / Product Identification Label?    
04 Are personnel in the Printing room wearing specified clean uniform and mask?    
05 Is printing machine specific parts (gauges) in calibration status?    
06    
TEMP______HUMIDITY_____
07 Is QC released packaging material to be used for respective batch available?    
09 Correct Printing of Batch no. ,Mfg Date &Expiry date .    
_______________________
PRODUCTION OFFICER DATE &TIME:_______________ Line Clearance awarded: YES □ NO □
___________
QA OFFICER DATE &TIME:________________ REMARKS: ________________________________________________

STAMP
STAMP
Page 35 of 48

Revision no:00
OVER PRINTING INFORMATION

Date: Time:
Batch No.: Batch Size:
Operator (Name): Signature:
Over printing information on unit carton:

Batch # Mfg. Date Expiry Date MRP Rs.
T-005 05-2022 04-2024 ----
Printing Incharge: ___________Production Pharmacist: ___________QA Officer: ___________

STAMP
STAMP
Page 36 of 48

Revision no:00
__
CONTROLLED
IN-PROCESS CHECK COPY:PRINTING
SHEET FOR NO COPYING WITHOUT MANAGER Q.A PERMISSION
STAMP
Date STAMP Time B. No Mfg. Date Expiry Date M.R.P Rs. Checked by
Page 37 of 48

Revision no:00
Prod. QA

STAMP
STAMP
Page 38 of 48

Revision no:00
TEAM LAY OUT SHEET AT OVER PRINTING STAGE

Start Time: Close Time:
Start Date: Close Date:
Date
Operator
Performed By: ____________ Checked By: ____________________

Operator
CONTROLLED COPY: NO COPYING WITHOUT MANAGER Q.A PERMISSION Production Officer
STAMP
STAMP
LINE CLEARANCE CHECKLIST FOR PACKING
Page 39 of 48

Revision no:00

Sr.# CLEARANCE PARAMETERS Yes No Yes No
Are there any traces of previous Product ____________Batch__________ in Area, Conveyer Belt, Shippers &
02    
Pallets
START UP OPERATION
03 Are equipment cleaned & shippers properly labeled with Equipment / Product Identification Label?    
04 Are personnel in the Packaging area wearing specified clean uniform?    
06 Is QC released Packaging material pertaining to respective batch available?    
Are Temperature and relative humidity in accordance to the requirements and recorded?    
07
08 Correct Over printing information on unit Carton    
a- Product Name    
b- Pack Size / Strength    
c- Batch No.    
d- Mfg. Date , Expiry Date    
e- MRP / PS Stamp    
09 Correct Embossing/ Over printing information on Blisters available?    
10 Presence of literature?    
PRODUCTION OFFICER:______________ DATE & TIME:_______________ Line Clearance awarded: YES □ NO □
QA OFFICER: _______________ DATE & TIME:________________ REMARKS: _________________________________
LINE clearance for more than one
CONTROLLED time NO
COPY: afterCOPYING
rechecking of above parameters
WITHOUT MANAGEReach time
Q.A PERMISSION
Date Time
STAMP Line clearance status
Checked by Rechecked by IPQC
STAMP
TEAM LAYOUT SHEET AT PACKING STAGE
Page 40 of 48

Revision no:00
Packing Start Time: Packing Closing Time:
Packing Starting Date: Packing Completion Date:
Name Time In Time Out Total Time
Checked By: ___________________ Verified by: _____________________

Belt Incharge Production Pharmacist
STAMP IN-PROCESS CONTROL SHEET FOR PACKING
STAMP
REDTime:
Date: ____________Start STAMP INDICATES ORIGIONAL
______________Close DOCUMENT
Time _____________
Status
YES : ✔ NO : X Page 41 of 48

Revision no:00
Bulk inspection Unit carton information Shippers packing

Presence of Retained
Date Time Mfg. Exp. No of Labeling, Checked by
Blisters Leaflet Unit Cartons Batch No MRP (Rs.) Leaflet Samples
Date Date Packs Sealing
REMARKS: ________________________________________________________________________________
Packing Pharmacist: _____________ Q.A. Officer: _______________
NOTE: 1) In process entries are taken after every 45 minutes by QA and Production alternatively.
2) QA officer will use Black ball point while Production officer will use Blue ball point.

STAMP
STAMP
Page 42 of 48

Revision no:00
CERTIFICATE OF ANALYSIS
General Tablet Section Finished
Date: Time: Sampled By Quantity QA Officer (Sign)

Sample Receiving Sample Receiving Sample Release Sample Release Time: QC Reference
Date: Time: Date: No.

White Color Round Shape Coated Tablet with engraved cut line on one side blistered in
Physical Appearance Alu/Alu ,packed in unit carton with leaflet pack size 2*7s.
Identification:
Width 8±0.04mm
Thickness 5±0.04mm
Hardness NMT 10 kg
Friability NMT 1 %
Dissolution NLT 75% as label claim
Remarks: _________________________________________________________________________
STAMP
STAMP
Checked By: ________________ VerifiedORIGIONAL
RED STAMP INDICATES By: _______________
DOCUMENT Approved By: ______________
Page 43 of 48

Revision no:00
QC Analyst Q.C. Manager QA Manager

STAMP
STAMP
Page 44 of 48

Revision no:00
FINISHED GOODS TRANSFER NOTE

For Trail: Pack Size: 2*7’s / unit carton
No of shippers Checked By Received by
Date Mfg. Date Exp. Date Total Quantity R&D
Full Part Box R&D Officer QA Officer Officer
Grand Total
Remarks: __________________________________________________________________________
Verified By: ____________
Section Incharge Production Manager Store Incharge

STAMP
STAMP
Page 45 of 48

Revision no:00
PACKING MATERIALS RECONCILIATION FOR COMMERCIAL

Date__________
Quantity Quantity Quantity Quantity Received
Description
Issued Used Rejected Returned By
Aluminum Foil
Alu-Alu Base Foil 260mm
Unit Carton
Leaflet
Outer Shipper
Packing Tape
Remarks: __________________________________________________________________________________
Section Incharge Production Manager Store Incharge QA Manager

STAMP
STAMP
Page 46 of 48

Revision no:00
BATCH RECONCILIATION
Sr. # Quantity Produced (Total Packs)
1 Commercial Packs
2 QA Retained Samples
3 Left Over (If Any With Adjustment)
4 Theoretical Yield
5 Practical Yield
6 Process Wastage
7 Date Of Completion
Remarks:_______________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________

STAMP
Checked By: ______________
CONTROLLEDReviewed
COPY: NO By: _________________
COPYING Approved
WITHOUT MANAGER Q.A By: _____________
PERMISSION
SectionRED
Incharge
STAMP Production Manager
QA Manager
Page 47 of 48

Revision no:00
DESTRUCTION NOTE
IN PROCESS MATERIAL REJECTION

Sign.
Quantity Reason for
Date Material QA
Destroyed destruction Production Officer
Officer
Printed Foil
Alu-Alu foil
Unit Cartons
Leaflets
Remarks: _________________________________________________________________________

Checked By: ______________
STAMP Reviewed By: _________________ Approved By: ___________
Section Incharge
STAMP
Production Manager QA Manager
Page 48 of 48

Empa 10MG T-005

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BRIELL Pharmaceuticals

BATCH MANUFACTURING RECORD

3 Batch Size: 2000Tabs . .

4 Manufacturing Date: 05-2022 .

5 Expiry Date: 04-2024 .

6 Shelf Life: 24Months .

7 Pack Size: 2*7s .

8 Registration Number: -------- .

9 BMR Issued Date:. 09-05-2022

10 BMR Submission Date: 10-05-2022

Reviewed By: ____________________ Approved By:________________

CONTROLLED COPY: NO COPYING WITHOUT MANAGER Q.A PERMISSION

Product Code: Doc no: R&D/BMR/001

BMR COMPLIANCE CHECKLIST

Product Code: Doc no: R&D/BMR/001

MASTER FORMULATION FOR RAW MATERIAL

Each Tablet Standard Batch

CONTROLLED COPY: NO COPYING WITHOUT MANAGER Q.A PERMISSION

Product Code: Doc no: R&D/BMR/001

CALCULATION OF ACTIVE PHARMACEUTICAL INGREDIENT (API)

Assay of API (Potency): 99.60% (as such)

Overage of API: _______________________

Label Claim: 10mg per Tablet

Weight of API per tablet( mg) = 100_ x Label Claim = 10.04mg/Tablet

Total Weight of API (g): __________20.08g________________________

Remarks (if any): __________________________________________

Product Code: Doc no: R&D/BMR/001

MANUFACTURING ORDER For Production Use

Coat Dry White 21.00gm 21.00gm

Product Code: Doc no: R&D/BMR/001

Registration No: --------- Shelf Life : 24 Months

Coat Dry White 21.00gm 21.00gm

Product Code: Doc no: R&D/BMR/001

VERIFICATION OF DISPENSED RAW MATERIALS

CONTROLLED COPY: NO COPYING WITHOUT MANAGER Q.A PERMISSION

Product Code: Doc no: R&D/BMR/001

1. All belongings of the previous product/ Material are

Checked by: ___________________ Verified by: ___________________

LIST OF EQUIPMENT USED DURING MANUFACTURING

Product Code: Doc no: R&D/BMR/001

Checked By: ___________________ Verified By: ______________

CONTROLLED COPY: NO COPYING WITHOUT MANAGER Q.A PERMISSION

Product Code: ------ Doc no: RD/BMR/001

LINE CLEARANCE CHECKLIST FOR GRANULATION

Product Code: ------ Doc no: RD/BMR/001

STANDARD MANUFACTURING PROCEDURE FOR GRANULATION

Sr.# Ingredients Actual Wt. (Kg)

CONTROLLED COPY: NO COPYING WITHOUT MANAGER Q.A PERMISSION

Product Code: ------ Doc no: RD/BMR/001

Performed Checked By Verified

CONTROLLED COPY: NO COPYING WITHOUT MANAGER Q.A PERMISSION

Product Code: ------ Doc no: RD/BMR/001

Performed Checked By Verified

CONTROLLED COPY: NO COPYING WITHOUT MANAGER Q.A PERMISSION

Product Code: ------ Doc no: RD/BMR/001

Analysis Report (Filled By QC)

Tests Specifications Results

Performed By: ______________ Checked by: _________________ Approved by: ______________

CONTROLLED COPY: NO COPYING WITHOUT MANAGER Q.A PERMISSION

Reviewed By: ____ Approved By:

Total Weight of API (g): 20.08g______________

Checked by: _ Verified by: _

Checked By: _____ Verified By:

Performed By: ______ Checked by: _ Approved by: ______

Total Mixing Time: Date:__

Performed by: _Checked by: Verified by: __

Total Weight received: _ Date: ___________

Performed By: ______ Checked by: _ Approved by: ______

QC Analyst _____ QC Manger

Date: _ Start Time: Close Time: _

Production Officer QA Officer :

Checked by: ______ Verified by:

Theoretical weight of grains:___ Kg Actual weight of compressed tablets:_ Kg

% Yield = _ % % Wastage = %

Performed by: Checked by: Verified by: __

Total Weight received: _ Date: ____________

Performed by: _ Checked by:

Performed By: Checked by: Approved by:

% Yield = _ % % Wastage = %

Performed by: Checked by: Verified by: __

Total Weight received: _ Date: ____________

02 Are there any traces of previous Product _______ Batch # in    