INPLANT TRAINING

BY:
SANJANA AMBRE (1) SHWETA CHAVAN (5)
SONIA CHITNIS (6) TANIA D’CRUZ (8)
RONAK JAIN (18) POOJA JOSHI (19)
RIZWAN KHAN (22) VIPLAV KSHIRSAGAR (25)
SHERYL NAZARETH (34) YASH SANCHETI (48)
NAUREEN SHAIKH (54) QAIS BHAISAHEB (41)
JITENDRA SINGH YADAV (63)

1
CONTENTS
 INTRODUCTION
 STORE ROOM

 DOCUMENTS IN THE STORES

 PRODUCTION DEPARTMENT

 TABLET
 PACKAGING
 CAPSULE
 DRY SYRUP
 QUALITY CONTROL

2
Introduction
•It is loan license industry.
•It manufacturers products for further
pharmaceutical industries but does not
involve in marketing field.
•It manufactures for :
1. Shalina Laboratories
2. SRS Laboratories
3. Alkem Laboratories
4. Aarti Laboratories
.

3
The company is divided into several departments:
 
1. Production department
2. Quality control department
3. Packaging department
4. Coating section
5. Store department

These various departments employ different STANDARD OPERATING

PROCEDURES.
 
Standard Operating Procedures: A set of step-by-step instructions
created by the organization to help workers carry out routine operations
so that maximum effectiveness can be achieved. They are also called as
SOP’s.

4
SOP FOR PRODUCTION DEPARTMENT
 
This includes the cleaning procedures for various Equipment
used in production department, such as:
1. Double cone blender
2. Sifter
3. Dehumidifier
4. Form fill seal machine
5. Hemson strip pack machine
6. ALU/ALU blister pack machine
7. Tray dryer
8. Mass mixer
9. Induction sealing
10.Conveyor belt
11.DM water plant
12.Machine balance

5
Apart from these, there are SOP’s regarding:
 
1. Entry & exit procedures
2. General cleaning of department &
miscellaneous items
3. Line Clearance of equipments
4. General manufacturing procedures
5. Sorting capsules
6. Sieve integrity
7. Training of department personnel
8. Disposal of waste material
9. Regeneration of DM water plant

6
SOP FOR QUALITY CONTROL DEPARTMENT
 
This includes the procedures regarding following points:
 
1. Laboratory safety
2. Cleaning of laboratory glassware
3. Preparation & standardization of volumetric solution
4. Sample sending to parties
5. Sampling of raw materials & packing materials
6. Swab test analysis & swab sampling for validation of test
surfaces
7. Receipt issuance: verification & maintenance of chemical
& glassware’s
8. Retesting of raw materials
9. Preparation of labels using pharmaceutical package
system
10.Preparation, storage & disposal of raw material control
sample.

7
SOP FOR QUALITY ANALYSIS DEPARTMENT
This includes the procedures regarding following points:
 
1. Preparation, approval, authorization, control, revision &
archiving of standard operating procedures
2. In process control
3. Line clearance
4. In process sampling by QA
5. Collection, preparation, storage & disposal of raw material,
finished product
6. Batch numbering system
7. Product complaint handling
8. Accepted tolerance in the frequency of calibration
9. Stability studies of product
10.Final approval of packed product
11.Reprocessing of batch
12.Temperature & humidity monitoring

8
SOP FOR MICROBIOLOGY DEPARTMENT
This includes the procedures regarding following points:
1. Operation & maintenance of microscope
2. Refrigeration operation
3. Autoclave validation
4. Sub-culturing of cultures
5. Media preparation record
6. Growth promotion test
7. Disposal of culture & media
8. Analysis of water
9. Environmental monitoring in microbiology room
10.Calibration of laminar air flow
11.SOP for fumigation
12.Cleaning of microbiology room
13.Gram staining
14.Operation & maintenance of incubator.

9
STORE ROOM

10
Store room has various departments:

1. B.S.R. : Bonded store room.

2. Dispensing room: Dispenses required amount of raw
material to the production area
3. Primary packaging area: The packaging material which
directly comes in contact with the product for e.g.
Aluminium foil, PVC sheet etc. are stored here
4. Secondary storage area: Secondary storage materials
like cartons shippers are stored here
5. Quarantine room: This is the room where materials
taken from the supplier is stored & then taken by Q.C.
department for testing.
6. Approved Raw Material store: After samples taken by
the QC. department, the approved materials are stored
here.

11
Actual process:
•Raw materials come from gate. The store manager checks the raw
materials & gives G.R. note (Goods receipt note) serially. Then the
materials are stored in quarantine area & labelled with an orange or
yellow colour which indicates that the material is under test.
•Label contains G.R. note, manufacturing date, expiry date,
manufacturing by and name of the material.
•Samples are taken for various tests by Q. C. department.
•After passing various tests they are given A. R. No. [Analytical release
number] Which indicates that material is approved & labelled with green
colour.
•If the materials do not match the specifications required, they are then
labelled with red colour which indicates that the material is rejected.
•After approval by the Q. C. department the materials are dispensed
according to their requirement for manufacturing.

12
Documents prepared in stores
 Following are the documents prepared in
stores:
1. Daily incoming material
2. Good receipt note
3. Q.C. sample issue slip
4. Batch sheet
5. Excess material consumption memo (MCM)
6. Excess material return memo (EMRM)

13
7. Online rejection memo (ORM)
8. Store rejection memo (STRM)
9. Rejection return memo (RRM)
10. Inter unit transfer slip
11. Destruction certificate
12. Material issue slip

14
Monthly incoming documents
 Following are the monthly incoming documents:
1. Cut off nos.
2. Raw material / packing material stock statement
3. WIP statement
4. Finished goods statement
5. Rejected material statement

15
Production Department
 Production department includes:
a. Tablet production
b. Capsule production
c. Dry syrup production
d. Effervescent granules production

16
17
 Tablet production
 Various processes involved in the production of
tablets are as follows:
1. Coating
2. Sifting
3. Granulation
4. Drying (multimilling is done)
5. Lubrication
6. Compression
7. Sorting
8. Final packing
18
1. Coating :-
Here active ingredients are coated to prevent the drug from atmosphere
or for pharmaceutical elegance. This step plays significant role in the drugs
or active ingredients which are hygroscopic or which need to protect from
atmosphere.
Coating is mostly carried out in raw material granulating machine i.e.
RMG.
RMG consists of a rotating pan with a lid. Mixing is done with the
impeller present in its centre. A sample ejector is present at the base with a
lock system to prevent ejection of sample during processes. Capacity: 100
kg
For coating load the material in pan along with coating solution and
rotate RMG at given rpm which is specific for individual product.

2. Sifting :-
Next step is sifting which is done using mechanical sifter. Active
ingredients as well as excepients are sifted with sieve no. 40.
After sifting the batch is separated into 4 lots and then granulation is
carried out separately for each lot.

19
 Granulation
Done in RMG.
Active ingredient and excipients
rotated at specified rpm.
Done for thorough mixing of active
ingredient and excipients.
Binding agent added and again rotated
in RMG at specified rpm for specific
product.

20
 DRYING
Granules formed are sifted and kept to
dry in fluidized bed dryer.
Drying time varies according to product.
The drying operation involves :

a.Loading
b. Assembling
c.Setting timer
d.Degusting of finger bag
e.Checking moisture content
f. Unloading
21
FLUDISED BED DRYER
22
Lubrication
The entire batch is then sent for lubrication in a
blender.
Capacity of blender : 460 kg.
Rpm : 15
Time : 10 min.

COMPRESSION
After lubrication, granules are sent for
compression in compression machines.
Compression Capacity of machine : 25837
Tablets at a time.
23
Compression operation:
 Includes hopper, upper punch, lower punch,
scrapper, rotating wheel and weight control
spindle, die cavity etc.
 Operation:
 Powder placed in hopper passes die cavity of
upper and lower punch.
 Tablet weight controlled with weigth spindle
clockwise direction increases weight and
anticlockwise direction decreases weight.
 Average weight, hardness, thickness be taken
every half an hour and recorded in a blank
sheet.

24
DOUBLE ROTARY
25
Sorting
 Quality control of the tablets is done after
compression.
 After that tablets need to be sorted before

final packaging i.e. the defective tablets like

the ones which are broken, chipped, capped,
blistered, mottled etc.
 Sorted tablets are again sent for multimilling

powdering and compression.

26
Tablet coating
 Conventional pan is used for the coating
process.
 Coating solution contains IPA, HPMC,

titanium dioxide, methylene propylene glycol.

 FILM COATING
 Methods of flim coating : Pan-pour and Pan-

spray method.
 Process variables involved : Pan and Spray

variables.

27
Need of film-coating
 Apperance
 Dust elimination
 Taste masking
 Odour masking
 Isolation
 Protection
 Drug release

28
 CONVENTIONAL
COATING PAN

SUGAR COATED
TABLETS
29
Packing
 After the sorting process, final packing is
done.
 There are 2 types of packing : Strip and

Blister packing.

 STRIP PACKING MACHINE : Henson

 Includes : hopper, sealing roller, cutting gear,

channel chute, heater, printer, thermostat.

30
Operation
 From the hopper tablet pass through the channel
chute.
 Rollers having cavity where tablet gets filled in

between the two aluminum foils coming from two

opposite sides between the rollers and gets sealed.
 It is then passed through the cutting gear and

strips are obtained.

 The foil coming from the left side of the roller

passes through the printer where batch no.,

manufacturing date etc. are printed before
entering the sealing roller.

31
Blister Packing
 It includes:
i. Hopper
ii. PVC cavity roller,
iii. Filling belt
iv. Sealing roller
v. Cutting gear
vi. Heater,
vii. Printer
viii. Thermostat.

32
33
OPERATION

 Tablets from hopper are aligned towards the

belt of PVC which passes through a roller with
cavities.
 Compressed air at 85°C leads to the

formation of cavity by melting.

 The tablet gets filled in the cavity while

passing through the belt.

 Aluminum foil comes from the opposite side

after passing through the printer.

34
 Both foils pass between 2 rollers where they
get sealed at 145°C to 160°C .
 It is cut by passing through a cutter and

strips are formed.

35
36
Record maintenance
 Each process was carried under the
supervision of the product supervisor.
 The report of each is to be entered into the

batch sheet.

37
 Batch sheet includes;
i. Information and records regarding the
process.
ii. Name of lubricant, excipient and binding
agents
iii. Time and temperature when the process or
particular stage is carried out by whom with
the sign of supervisor.
iv. Date, batch no., lot no., name of product,
stage previous, current process and stage to
be carried out with sign.

38
Capsule Production

39
CAPSULE PRODUCTION
i. Sifting: Active ingredients and excipient are
sifted using mechanical sifter (sieve #40).
ii. Mixing and Blending: it is done in a blender.
Capacity- 250kg, rpm- 20-22 and time-
30 minutes or as specified individual
monograph.

40
 Filling and Sealing: Machines- MV-115.
iii.
Scorpio.
The above machines are semi automating
filling and sealing machines.
Parts of machine:
a) Race wag
b) Capsule slider
c) Rectifier block
d) Push blade
e) Auger

41
Operation
 Fill empty capsules in hopper.
 Start vacuum and air supply .
 Filling of capsule ring on loading turn table.
 After filling rotate ring 2-3 times to separate

cap and body.

42
 Powder filling:
i. Place body ring on the turn table.
ii. Fill powder in hopper. Pull powder hopper
over ring and fill.
iii. Remove filled body ring and place cap ring
on body ring.
iv. Place filled caps on support rods with body
towards pin plate.
v. Lock cap and body by using compression
foot wall compression air up to 6kg.

43
 Polishing and sorting:
i. Polishing was done manually using liquid
paraffin in 4 stages.
ii. Sometimes salt polishing is also done in
case the product is required urgently.
iii. Sorting is done alone with polishing.
iv. Problems associated with capsules noticed
during polishing are denting, notching,
cutting and pinhole.

44
  Packaging:
i. Capsules were packed in blisters.
ii. It contains 2 types of foils.
 PVC
 Aluminum foil
 PVC is always 4 mm larger than aluminum
foil in order to form cavity.

45
 DRY SYRUP PRODUCTION
1. Milling: Multi-milling sugar
2. Drying: For 2 hrs in tray dryer
3. Sifting: Sieve through #55
4. Mixing: For 30 mins along with granulation
and lubrication
5. Packing: In dry bottle seal or sachets

46
47
QUALITY CONTROL DEPARTMENT
1. Instrumental section
2. Chemical section
3. Microbiological section
4. In process Q.C section

48
49
 Instrumental section
Instruments employed:-
1. Disintegration test apparatus (Veego)
2. Dissolution test apparatus (Veego)
3. Veego friability tester
4. Oven (Cintex)
5. Vibronic ultrasound cleaner
6. Bulk density apparatus (Sakova)
7. Tablet hardness tester (Thermontis)
8. Refractometer (Rajdhani)
9. Polarimeter (Rajdhani)
10. UV visible spectrophotometer (Shimadhzu)
11. Photo fluorometer (Systonics)
12. Karl Fischer apparatus (Veego)
50
Various tests carried out in Q.C. dept
A) On tablets
1. Disintegration
2. Dissolution
3. Hardness
4. Friability
5. Uniformity of content
6. Uniformity of weight

51
B) On capsules
1. Dissolution
2. Disintegration
3. Length
4. Uniformity of capsules
5. Uniformity of weight

C)Miscellaneous tests:
1. Moisture content
2. Bulk density of granules
3. Microbiological tests and raw material testings.

52
 CHEMICAL SECTION
Here all the chemicals stored and chemical analysis on
raw and finished goods is carried out

53
 MICROBIOLOGICAL SECTION
Here microbiological testings are carried out on raw
material and excipients which are required to be tested
such as Griseofulvin, talc, etc.

54
 IN PROCESS Q.C
It is carried out to maintain quality of product and
conditions required for the production during the on
going process with the view to avoid further batch
failures.
Physical parameters like temperature and humidity are
tested of the 600m area where productionis done. Also
involves checking of tablets on container rgarding the on
goig process etc.

55
It involves checking of physical parameters of tablets &
capsules done every 2 hrs. Such individual wt. variation,
thickness, hardness, friability etc. All these tests are noted on
an IPQC sheet. IPQC also involves leak test of blisters & strips
during packaging process to check the seal.

Miscellaneous:
1. Testings on packaging materials & packaging containers
are also carried out such as length, breadth, width,
grammage etc. It plays special significance e.g. PVC should
always to 4 mm greater in size than aluminium since it forms
cavity. Therefore testing of gauze size, width etc. Plays a
significant role.

56
2. Sampling procedure: Sampling of raw material is
done.
Finished products are sent to Q.C. dept along with
intimation slip which includes batch no., mfg date,
quantity of batch and sign of batch supervisor.
Analysis is done according to pharmacopoeia products &
for non-pharmacopoeia products, analysis is done for
according to S.O.P

57
TESTS PERFORMED (during training
period):
1. Dissolution test for ciprosan (Gprofloxacin-500mg)
USP
2. Dissolution tests for Griseofulvin (Griseofulvin-
500mg)
3. Uniformity content of Wormex (i.e. mebendazole
100mg) USP
4. TLC of mebendazole (qualitative test)
5. In process quality control of tac Cevite Cap Ampi-500.

58