Production Sops

INDEX FOR SOP – PRODUCTION
S.No. TITLE SOP. REF. No.

1. Cleaning of Sifter PR/SOP/01
2. Operation of Sifter PR/SOP/02
3. Cleaning of RMG PR/SOP/03
4. Operation of RMG PR/SOP/04
5. Operation & calibration of balance (platform) PR/SOP/05
6. Cleaning of Fluid bed dryer PR/SOP/06
7. Operation of Fluid bed dryer PR/SOP/07
8. Cleaning of multi miller PR/SOP/08
9. Operation of multi miller PR/SOP/09
10. Cleaning of punching machines I & II PR/SOP/10
Cleaning of compression-tooling (Punches & Dyes)
11. Operation of compression machines I & II PR/SOP/11
12. Procedure for In-process Quality Testing PR/SOP/12
13. Storage of in-process tablets & granules PR/SOP/13
14. Cleaning of conventional coating pan PR/SOP/14
15. Operation of conventional coating pan PR/SOP/15
16. Cleaning of spray gun PR/SOP/16
17. Operation of spray gun PR/SOP/17
18. Handling procedure for Product Recoveries PR/SOP/18
19. Cleaning of polishing pan PR/SOP/19
20. Operation of polishing pan PR/SOP/20
21. Cleaning of tablet printing machine PR/SOP/21
22. Operation of tablet printing machine PR/SOP/22
23. Cleaning of blister packing machine PR/SOP/23
24 Operation of blister packing machine PR/SOP/24
25. Cleaning of strip packing machine PR/SOP/25
26. Operation of strip packing machine PR/SOP/26

27. Cleaning of double cone blenders - 1 & 2 PR/SOP/27
28. Operation of double cone blender – 1 & 2 PR/SOP/28
29. Cleaning of manual capsule filling machine PR/SOP/29
30. Operation of manual capsule filling machine PR/SOP/30
31 Cleaning of Starch paste, Coating solution preparation PR/SOP/31
vessel
32. Cleaning of Colloid mill PR/SOP/32
33. Working procedure for packing department PR/SOP/33
34. Procedure for overprinting control PR/SOP/34
35. Reconciliation of packing material PR/SOP/35
36. Packing slip on final shipper PR/SOP/36
37. Maintenance of Master BMR PR/SOP/37
38. Man power entry and exit procedure PR/SOP/38
39. Cleaning of semi automatic capsule filling machine PR/SOP/39
40. Operation of semi automatic capsule filling machine PR/SOP/40
41. Stacking of shippers PR/SOP/41
42. Policy on replacement of punches PR/SOP/42
43. Cross contamination control PR/SOP/43
44. Environmental monitoring PR/SOP/44
45. Personal hygiene, clothing & dress code PR/SOP/45
46. Production of DM Water. PR/SOP/46
47. Operation and calibration of Balance Cap. 3.0 Kgs. PR/SOP/47
48. Cleaning procedure for AHU filters. PR/SOP/48
49. Cleaning & operation procedure for Dispensing booth PR/SOP/49
50. Polishing procedure for filled Capsules PR/SOP/50
Cleaning of Sifter
4.0 Cleaning Agent : DM Water.
5.0 Cleaning Procedure :
1. Switch off the power control of the equipment and the main switch.
2. Spillage of Water on electrical parts like motor and starters are to be avoided.
3. As soon as the sifting process is over, dismantle the parts of SS feed hopper,
SS frame, holding the sieve in place and SS wire mesh sieve
4. Remove all the residual powder adhering to the above mentioned articles with the help of a
nylon brush.
6. Wash these articles with the help of running DM water.
7. Rub the articles with the help of sponge and wash with DM water.
8. Clean the articles with DM water to remove all traces of previous product.
9. Intimate Q.C. to collect rinse water / swabs for testing.
10. Drain off all the water and dry all the articles with the help of an Air blower.
11. Clean the exterior of the sifter stand and motor assembly with the help of a lint free wet cloth.
12. Carry out step 1 to 5 for the SS base plate with discharge outlet attached to the sifter stand.
13. Equipment Cleaning Testing results are complies / does not comply by Q.C. personnel as per
Prescribed test methods.
14. If the test results are complies, the cleaned and dried parts to be assembled to the equipment
and affix a cleaning label.
15. If the test results are does not comply, the parts to be cleaned again carefully and inform Q.C.
To collect sample for testing. Cleaning should be done until the results are obtain as desired
limits.
Operation of sifter
Precautions:
1. The operators should wear nose mask, goggles and hand gloves while handling the material.
2.The amount of material on the screen should be small so that passage of small particles is
not obstructed by larger particles.
3.The motion should not be too vigorous so as to cause size reduction of the particles or damage
to the screen.
5.0 Principle :
To impart horizontal rotary motion to the particle by vibration generated out of balance flywheel.
This is done to obtain a material of uniform particle size and free from foreign particles.
6.0 Method of operation / working

1. Fix the suitable size SS screen mesh, as specified in the BMR for individual product.
2. The amplitude of vibration is adjusted by movable weight on the flywheel.
3. The material is poured on the mesh with a scoop.
4. The sifted material is collected in a clean polyethylene bag fitted in a clean container .
5. The dust and other particles remaining over the screen are thrown away.
6. Polyethylene bag is tied with a thread tightly and the container closed with a lid. The container
is to be properly labeled with in-process label .
7. After completion of sifting of the material the charging port, the wire mesh screen and the other
SS parts coming directly into contact with the product are cleaned with water and dried.
8. The other parts of the machine are cleaned using vacuum cleaner.
Cleaning of RMG Mixer

Cleaning Agent: DM water.
4.0 Procedure for Cleaning :

1. Switch off the power control of the equipment and the main switch.
2. Wear gloves wherever chemical is used for cleaning to avoid bodily contact.
3. Spillage of Chemicals and Water on electrical parts like motor and starters are to be avoided.
4. Clean the lid and vessel of the mixer with the jet of tap water.
5. The mixer is rinsed with hot water, to remove adhered lumps of powder.
6. Collect the drained water into a plastic drum and drain off in the drainage.
7. Pour approximately 15 Lts. Of DM water into the mixer. and run the mixer for 15 minutes.
Then use nylon brush to remove any adhered material.
8. Ensure that no material is adhered to the corner and edges of the shaft.
9. Remove the water and rinse with fresh DM water and inform Q.C to collect the sample of rinse
/ swab for testing.
10. If the test results are complies, dry it by using clean muslin cloth. And affix a cleaning label.
11. If the test results are does not comply, the equipment should be cleaned again carefully and
inform Q.C. To collect sample for testing. Cleaning should be done until the results are obtain
the desired limits.
12. Cover the mixer with lid, Protect the mixer from atmospheric dust by using polythene bag.
Operation of RMG Mixer
5.0 Procedure:
1. Ensure that the mixer is properly cleaned and dried before the operation.
2. Use gloves during loading and unloading operation of materials.
3. Ensure that the machine is not overloaded by more than its capacity.
4. Load the materials with the help of a scoop as per specified sequence. Close the lid with the
help of locking screws.
5. Run the machine for the specified time as per the individual BPR for Dry mix then add the
Paste as per the sequence of the BMR and run the mixer for specified time of the BMR for
Wet mixing.
6. Inform QC to collect the sample from the mixed material through In-process intimation slip and
get the approval through In-process Analysis Report
7. Unload the material mix into a cleaned container and weigh the material and paste the label.
8. Make relevant entries in the BMR. Shift the material for further processing of drying in FBD
as per individual monograph.
Operation and calibration of balance (Platform)
4.0 Precautions:
1. Ensure that the balances must be free from dust.
2. Place the balances on shock proof basement.
3. Avoid the spillages on the balances when the time of dispensing.
4. Ensure the spirit level in the centre of the ring provided in the balance.
5. Record the every day calibration details.
6. Ensure that the standard weight must be periodically calibrated by out side agency.
5.0 Calibration Procedure:
1. Switch on the main and the stitch on the balance.

2. Wait for few minutes for display comes to 0.00
3. Calibrating the balance every day by putting below weights and maintain the record.
Std. Weight Checked Observed Weight %Deviation

500 g 0.2 %
5 Kgs 0.2 %
10 Kgs 0.2 %
15 Kgs 0.2 %
6.0 Dispensing Procedure:
1. Place the tare on the platform of the balance.

2. Record the tare of the weight on the label and press auto zero button. Then it displays 0.000
6. Weigh the required quantity of the material into the tare.
7. Record the Net weight of the material.
8. Remove the material from the balance.
9. Clean the platform of the balance.
10. Weigh the remaining material and put a tag and place the material in the stores.
6.0 General care & precautions
 Proper handling of the instrument.

 Do not load heavy weights, which are out of its capacity,
 See that the instrument is not exposed to the vibration forming devices.
7.0 Maintenance / repairs
If the instrument does not produce required calibration results or its response is poor then it should
be labeled “FAULTY” and should be repaired or serviced.
Calibration Frequency : Daily.
Cleaning of Fluid Bed Dryer
4. 0 Procedure : Cleaning procedure used for trolley bowl.

Washing procedure used for filtering cloth.
4.1 Cleaning procedure used for trolley bowl.
1. Ensure that the Equipment is stopped and the Supply Control is off.
4. Clean the body of the dryer and plenum with a dry clean duster.
5. Detach finger bag from hook by opening perplex window in the retarding chamber.
a) Unclamp the fixing bolts of retarding chamber and allow it to rest on the trolley.
Take out trolley bowl along with the filter cloth.
b) Bring the trolley bowl and filter cloth to the washing area.
6. Clean the trolley bowl with stream of manzeera water with using a nylon scrubber.
7. Clean thoroughly with using a sponge and wash with manzeera water.
8. Then clean the bowl thoroughly with DM water followed.
9. Inform Q.C. to collect the sample of rinse / swab for testing of cleaning.
10. Allow the bowl for drying, if the test results are complies the bowl is fix to the FBD.
11. Further dry by running FBD at 70c (without material) for 15 minutes.
12. After fixing the filtering cloth and bowl, paste the status of cleaning label.
4.2 Washing procedure used for filtering cloth.
1. Take about 50 liters of Manzeera water into a plastic drum.

2. Dip the filter cloth into the water for 1 hour.
3. Rub the cloth, wash in the water and remove the cloth from that drum. Drain the water.
4. Take about 50 liters of Manzeera water into a plastic drum and dip the filtering cloth into
The water and wash thoroughly. Drain the water.
5. Take about 50 liters of DM water and wash the filter cloth thoroughly and drain the water.
6. Take about 50 liters of DM water and wash the filter cloth and inform the Q.C. to collect the
Water for testing. Allow the cloth for drying and the test results are complies, fix the cloth to
The FBD.
7. If the test results are does not comply, wash again the cloth until the test results are obtain
the desired limits.
5. Cleaning Frequency :
1. For every change of the Product.

2. If the same batches are processed for 20 batches, then go for cleaning.
3. If the filtering cloth is new, wash the cloth and fix to the FBD.
6. PROCEDURE FOR MAINTENANCE FBD:
1. Ensure the temperature controllers are in good condition.

2. Ensure the air is freely flow as per the designed direction from inlet to out let.
3. AHU Filters must be cleaned in a periodic schedule.
Operation of Fluid Bed Dryer

Precautions:
1. Check and certify that area and equipment are clean and suitable for starting the operation.
2. Ensure that main switch is in ‘OFF’ position before dismantling FBD for loading.
5 Please do not load material more than 2/3rd of the bowl.
5.0 Operation
1. Load the bowl with material to be dried. Place the material uniformly in the bowl to avoid
lumps.
2. Push the bowl into the appropriate Position of the FBD.
3. Lift the bottom of the FBD by moving the jack handle to the opposite side and seal the
trolley to the retarding chamber.
4. Check and ensure that there is no leakage.
5. Set the timer and switch on heating and fluidization, maintaining the desired inlet air
temperature.
6. Stop drying at intervals of specified duration in the individual BMR, de-dust the finger bag
by shaking it.
7. Continue heating for required time. Switch off the heating and main switch.
8. Shake the finger bag vigorously. Pull out the bowl.
9. Make relevant entries in the BMR.
10. The material is shift to the further process as per the BPR.
Cleaning of Multi-Mill
4.0 Cleaning Agent: DM Water.
5.0 Precautions:
1. Ensure that the Equipment power supply is off.
5. Procedure :
1. Dismantled the parts are washed with flowing manzeera water in the washing area, till the parts
Are free from suspended matter.
2. Scrub all the parts with sponge. Then clean all the dismantled parts with DM water till the
rinses are free from previous product traces.
3. Inform Q.C. to collect water for testing.
4. The roof of the milling chamber to be wiped clean with lint free cloth. Care is required to be
taken that no water enters the electric motor.
5. All the loose gaskets are cleaned and examined to confirm that these are not cracked or likely to
shed any particles.
6. If the testing results complies for cleaning, the cleaned parts will be re assembled.
6. If the testing results does not comply, again clean the parts until obtain desired limits.
7.Cover the cleaned equipment with a fresh clean poly cover.
8. Fix a status of cleaning label.
Operation of Multi-Mill
Precautions:
1. Ensure that the equipment is free from dust and the main switch is in ‘OFF’ position before
operation.
3. Ensure that blades fixed in the rotor are in 4, 3, 4, 3 sequence and none of the blades are
missing. Fix the key to the central shaft.
4. Check that knives of the rotor are not touching the screen by turning the belt by hand.
5. Close and lock the milling chamber guards.
5.0 Operation
1. Place a new polythene bag in a clean plastic container and tie to the bottom of the
multi-mill chamber.
2. Load the material to be milled into feeding hopper by means of a clean SS scoop with
handle.
3. Switch on the main switch and start milling.
4. Collect the milled material into the bottom of the plastic container.
5. When the container is full, switch off the mill and untie the poly bag from mill chamber.
Tie the bag and fix appropriate ‘in-process label to the container.
6. Repeat the procedure as often as required, always fixing the container in similar manner to
the discharge chamber of the mill.
5. At the end of the milling operation, switch off the mill and disconnect the electrical
mains.
Dismantling
1. Remove feed hopper and lid.

2. Unlock milling number guards.
3. Unscrew two side nuts to remove screen and base plate.
4. Remove the rotor with blades and the key.
5. Clean the equipment and dismantled parts as per the standard cleaning procedure.
Cleaning Tablet compression Machines I & II

Cleaning of Tooling set (Punches & Dyes).
Chemicals Used: Kerosene or acetone and thinner,
5.0 Precautions:
2. Spillage of Chemicals to be avoided on the electric parts.
3. Ensure that the punches and dyes are stored in a suitable box.
4. Lubricant oil should be filled in the small bottle provided to the machine.
5. Ensure the Lubricant oil should not be leaked and dropped into the blend.
6. If any drop of the lubricant oil is mixed with the blend, carefully remove that round of the
compressed tablets.
6.0 Cleaning procedure for Punching Machine :
1. Switch off the machine and mains of the power supply.

2. Remove the Hoppers and Feed frames and tablet Tracks from the Compression Machine.
3. Clean the machine with nylon brush and clean cloth. If require use air blower for cleaning.
4. Ensure that the cleaning is remove all the traces of previous product.
5. All for drying for some time. After drying fix the cleaned parts to the Machine.
7.0 Procedure for Cleaning of Hoppers Feed frames and Tablet tracks :

2. Remove the Hoppers and Feed frames and tablet Tracks from the Compression Machine.
3. Clean the above SS parts with DM water at washing area.
4. Ensure that the cleaning is remove all the traces of previous product.
5. All for drying for some time. After drying fix the parts to the Machine.
8.0 Procedure for Cleaning of Punches and Dyes :

2. Carefully remove the Upper Punches and Lower Punches from the Compression Machine.
3. Clean the punches with cotton, and brush to remove traces of the previous product.
4. Take the Kerosene in a tray and dip the punches for 30 minutes.
5. Clean the punches with Nylon brush.
6. Clean the punches with dry Cotton.
7. Allow the punches to dry for about 15 minutes.
8. Wipe the punches with 20 : 40 oil with using cotton.
9. Store the punches in a suitable box.
9.0 Fix the Punches and Dyes to the Compression Machine :

2. Bring the suitable (according to the BMR) cleaned punches to the Compression Machine.
3. Fix the punches carefully to the Machine.
4. Take some quantity of the talc into the Hopper and run the machine.
5. Discard the talc tablets.
6. Take some quantity of the blend into the Hopper and run the machine and collect and discard
the first 2 rounds of tablets (54 tablets).
7. Collect the tablets into a cleaned plastic drum and check the physical parameters of the tablets.
10.Maintenance of Compression tooling :

1. Record the Compression tooling sets with different sizes and No. of punches.
Operation of Compression Machines – I & II
Utensils Used: Scoops and feeders, punches and dyes.
5.0 Lubricants Used: Food Grade Lubricants.
6.0 Precautions:
1. Check and certify that area and equipment are clean and suitable for starting the operation.
2. Ensure that main switch is in ‘OFF’ position before dismantling and assembling.
3. Use gloves during loading and unloading operation of material.
4. Ensure the lubricant oil is not in a position to drop and add to the blend.
7.0 Expected Problems:
(1) Sticking- the ability of the lubricated material to adhere to compresses of machine surfaces.
(2) Capping- the ability of tablet to crack under pressure when force is applied. It also indicates
the cohesive strength of the inner layers of the tablet. The moisture content may not sufficient
to compress the tablet. Ensure the moisture content.
8.0 Operation of the Compression Machine :
1. Fill the lubricated product / Blend in the hopper/s of the rotary compression machine
2. Check the flow of the material on the compressor disk and affix status label.
3. Adjust the require pressure to form the tablet of required size, shape and weight.
4. Physically check the 20 tablets weight and weigh the individual weight of the each tablet
for the 20 tablets.
5. If the checking parameters are not meeting with our product specifications
adjust the compressor lever up to required rate. Again check the physical parameters of the
tablets as 20 tablets weight and weigh the individual weight of the each tablet
for the 20 tablets and recorded in the in-process record in the BMR.
6. Check the 20 tablets weight at every 30 minutes interval of the compression.
7. Check the D.T , Hardness and Friability at every 1 hour interval of the compression.
8. Ensure that compressed tablets are uniform in shape size and weight and also without
sticking and tapping problems.
9. Inform the QC department for checking the samples as stated in the BMR through
In-process intimation slip .
10. Make relevant entries in BMR and Compression Record
11. Get the approval of QC and keep the material in polythene bags with in-process label
12. Transfer the material to subsequent department through Material transfer Note
9.0 Preventive Maintenance: Once in 6 months.
1. Ensure all the switches are put off and the area is clean and dried.
2. Service the machine with trained operators.
3. Nylon Brush, Lint free wet cloth & dry cloth, Allen Keys and
spanner of relevant size used.
4. The record should be maintained.
Procedure for in-process Quality Testing

Procedure :
1. Every day at morning session one Q.C. Chemist will inspect the processing areas.
2. The chemist will check the cleanliness of the areas.
3. The chemist will check the physical parameters of the online punching tablets, online filling
capsules in the IPQC testing lab.
4. The chemist will check the online entries of the physical parameters of the products.
5. The chemist will collect the samples from the online process from each section and to be
tested in the lab.
6. The chemist will collect the strips and blisters from the online machine and test the leak test in
the lab.
7. The chemist will direct the operators for any deviations of the product process.
8. The chemist will check the packing of the products and found any deviations of the packing,
that should be intimated to the packing supervisor and inform to the Q.C. Manager.
9. The chemist test results should be entered in the documents.
5.0 Frequency of the IPQC :
1. Two times in a Day session : Normally between 9.0 AM to 10.0 AM.

Normally between 2.0 PM to 3.0 PM.
2. Leak test frequency

Two times in a day session : Normally between 9.0 AM to 10.0 AM.
Normally between 2.0 PM to 3.0 PM.
Storage of in-process tablets and granules
4.0 Equipment Used: Polythene bags and suitable containers.
5.0 Precautions: 1.Ensure that the storage area is clean and neat
7.0 Day Storage Procedure :
GRANULES
1. The granules will be unloaded into these polythene bags in the containers to approximately
80-90% of the holding capacity of these bags to facilitate with proper tying.
2. A label indicating product, batch number, serial number of the container and total number to
containers will be affixed on the exterior of the container. Put one slip inner side of the lid of
the container.
3. All these containers of a batch will be once again weighed, to determine the gross weight and
consequently the net weight of the granules.
4. The container will then be transferred on a suitable trolley to the WIP area. The containers will
be stored on pallets in two rows with the maximum height of two containers.
5. All the containers of a particular batch will be segregated and placed in such a way as batch
wise.
6. All the containers are affix the labels with details against the BMRs.
Tablets
1. A requisite number of aluminum containers, each containing a polybag, will be pre-weighed

and issued to the compression department.
2. Compressed tablets from the machine will be stored in these containers which will be labeled
prior to collection of the tablets.
3. The compressed tablets will be stored in the polybags in these containers to approximately
80-90% of the holding capacity of the polybag to facilitate proper tying with twine.
4. An additional label similar to the one affixed on the exterior of the container will also be
put in the inner side of the lid of the container and the container will be closed.
5. At the end of compression process, all such containers containing tablets will be once again
weighed to determine gross weight and consequently net weight of the tablets.
6. These containers will then be transferred on a trolley to the WIP area and stored in a separate
zone designated for compressed tablets.
7. All the containers of a particular batch will be segregated and placed in such a way as batch
wise.
8. All the containers are affix the labels with details against the BMRs.
Cleaning of conventional coating pans
Equipment Used: Nylon Brush, Air Blower, Lint free wet & dry cloth.
5.0 Chemicals Used: DM Water.
6.0 Precautions:
4. Ensure that the equipment is properly dried after every operation.
5. Care should be taken as eyes are covered protected by goggles and full size PVC Gloves are
worn to cover arms.
7.0 Procedure for cleaning of the Coating Pans :
1. As soon as the coating operation is over, remove the coated tablets in suitable containers.
Remove the dry powder from the pan, if any.
2. Pour approximately 20 liters of hot water (80-85C) into the pan and allow the pan to rotate for
about 30 minutes.
3. Remove this turbid water using a plastic mug and transfer it into a plastic bucket.
4. Clean the inner surface of the pan with clean cloth.
5. Place about 20 liters of DM water into the pans. Allow the pan to rotate for 15 minutes.
6. Remove the water into a plastic drum and drain off the water.
7. Inform Q.C. to collect the rinse water / swab for testing.
8. Wipe the inner surface of the pan with a lint free clean cloth.
9. If the testing results are complies the pans should be labeled with status of cleaning.
7.0 Procedure for cleaning of the Blower :
A. Cleaning Procedure for batch to batch changeover
1. Dismantling – Remove the blower pipe from the body.

2. Cleaning of blower pipe – Clean the blower pipe from inside and outside using compressed
air. Wipe the external surface with a duster.
3. Cleaning of the blower body – Wipe the external surface with a duster / clean cloth.
B. Cleaning Procedure for product to product changeover
1. Dismantling – Remove the blower pipe from the body.

2. Cleaning of blower body – Clean the body surface, motor and fan using compressed air
from outside as well as inside.
3. De-dust the external surface with a duster. Wipe it with wet duster and dry it with a duster.
4. Cleaning of blower pipe – First clean it from inside and outside with a jet of potable water
using a soft nylon brush.
5. Then clean with 0.1% Teepol solution and again with a jet of potable water. Finally rinse
with DM water.
6. Drying of the blower pipe
(a) Fix the cleaned pipe on the cleaned blower body.
(b) Start the hot air blower.
(c) Adjust the temperature of the air to 100C.
(d) Continue airflow till pipe gets totally dried.
(e) Switch off the heater of air blower and allow to cool to room temperature.
Operation of conventional coating pan

Equipment Used:
Hot air blowers, Spray gun, polythene bags
5.0 Chemicals Used:
Compressed tablets which need coating and the respective coating material solution as per Product
Master.
6.0 Precautions:
1. Ensure that the Equipment is cleaned and dried before operation.

2. All the Coating material should be homogenously mixed and to ensure uniform
coating solution.
7.0 Coating Operation Procedure:
1. Fix the exhaust and hot air blower pipes.

2. Load the weighed quantity of un coated tablets from the container into the coating pan.
3. Switch on the mains of the following :
a. Coating pan
b. Exhaust system
c. Hot air blowers
4. Ensure the working and effectiveness of exhaust system and hot air blowers.
5. Arrange the position of hot air blowers, exhaust pipes and spray gun.
6. Fill the coating solution into the bowl of the spray gun.
7. Carry out coating operation as per the standard procedure laid down in the product BMR.
8. Check for uniform spray of the coating solution from the spray gun.
9. Check for the uniform rotation of the coating pan and the tablets rotation.
10. Check for the hot air to the tablets.
10.After completion of coating, check laid down physical parameters of coated tablets as per the
BMR.
11.Remove the coated tablets from the pan into double poly bags in an cleaned plastic containers
properly labeled with in-process label .
8.0. Dismantling
1. Switch off the mains of the following :
a. Hot air blowers
b. Exhaust system
c. Coating pan
2. Remove :
a. Hot air blower pipes
b. Exhaust pipes
Cleaning of spray gun
Equipment Used: Nylon Brush, Lint free wet cloth,
5.0 Chemicals Used: Water, 0.1% Teepol, DM water
6.0 Precautions:
1. Switch off the power supply to the equipment.
2..Ensure that the equipment is properly dried after every operation.
3. Use clean lint free dusters during entire cleaning operation.
7.0 Procedure:
1. Dip the gun in SS bowl containing potable water, for about ½ hr.
2. Scrub the external surface of gun air cap and needle with 0.1% Teepol solution.
3. Clean the outer and inside surface with jet of water orifice, by pressing trigger.
4. Pass the steam through orifice by pressing trigger, clean the outer surface with
steam.
5. Finally clean it with DM water.
6. Wipe the dismantled part and body of the gun with lint free duster.
6. Store the gun and its part in an appropriate clean poly bag until use.
Operation of spray gun

4.0 Precautions:
1.Ensure that the Equipment is cleaned and dried before operation.

2.All the Coating material should be homogenously mixed and to ensure uniform coating.
3.Spillage of Chemicals and Water on electrical parts like motor and starters are to be avoided.
4.Wear gloves wherever chemical is used for cleaning to avoid bodily contact.
5.Ensure that the equipment is properly dried after every operation.
5.0 Procedure
1. Connect Air blower tube to Spray Gun and check whether the air flow is proper from the
spray nozzle
2. Mix the film coating solution in the spray gun container to make a homogenous mix.
3. Press the nozzle of the spray gun and test for uniform spraying on a empty surface.
4. Then Spray the solution directly on the tablets in the coating pan.
5. Check the uniform spray of the solution to the tablets.
Handling of Product Recoveries
4.0 Precedure :
1. At every end of a batch the yield should be calculated carefully.

2. Q.C. Samples, IPQC samples, Control Samples and Stability Samples should be considered in
that caculations.
3. Left overs at each end of a process for a batch has to be carefully separated with a label and
preserve in a plastic containers with a proper status label.
4. The above recovers are checked the status of the quality, if no deviation in quality, the material
is to be added to the further batches upto not more than 2 % of the batch yield.
5. If the material is deviating with quality, the material is to be destroyed in intimation of
Production manager.
6. The relevant entries should be entered in the BMR.
Cleaning of polishing pan
Equipment Used: Nylon Brush, Air Blower, Lint free wet cloth, vacuum cleaner
5.0 Precautions:
7.0 Procedure for cleaning :
1. Remove all the tablets of the previous batch into a suitable containers and affix the label.
2. Clean with Vacuum cleaner, inside of the pan to remove loose particles.
3. Dismantle the equipment and cloth from the equipment.
4. Remove the cloth and clean with fresh cleaned cotton and preserve in a poly bag with label.
5. Use dedicated cloth to the prescribed product.
6. We have 3 cloths : - used for dedicated cloths for dedicated products as follows:
1). Novotone forte Tablets. 2). Ibuprofen Tablets. 3). Phenyl Butazone Tablets.
Operation of polishing pan
Chemicals Used:
Bees wax or Carnuba Wax, Chloroform.
6.0 Precautions:
1. Use dedicated cloth for each product.

2. Ensure that main switch is in ‘OFF’ position before loading the tablets.
4. Wear rubber gloves, goggles and protective clothing during this procedure.
7.0 Procedure :
1. Prepare the polishing solution and mix well for uniform solution.
2. If the operation is smooth put the required lot coated tablets in polishing pan.
3. Apply the polishing liquid which is made of bees wax, carnauba wax and chloroform
4. Run the pan for 30 minutes to ensure proper polishing of coated tablets.
5. Fix a equipment status label indicating the operation .
6. Physically check the polishing material for clean polished surface.
7. Transfer the polished tablets in a plastic containers.
8. Put the Polythene bag into a cleaned and air tight container with in process label
9. Transfer the polishing material to subsequent department through material transfer note
Cleaning of Tablet Printing Machine

Equipment Used:
Nylon Brush, Air Blower, Lint free wet cloth.
5.0 Chemicals Used:
DM water, Teepol, Isopropyl Alcohol,
6.0 Precautions:
Procedure :
1. Dismantle the following parts of the Tablet Printing Machine by using suitable spanners and
Allen keys.
a. Dyes
b. Rubber roller
c. Ink bowl
d. Rotating feeding disc
e. Hopper
f. Air nozzles
g. Pressure regulator
2. Clean the ink bowl, Rubber roller and dyes with initially with isopropyl alcohol or thinner.
3. Wipe the roller surfaces and ink bowl with wet lint free cloth.
4. Again wash with DM water and wipe using a dry cloth.
5. Clean the hopper, rotating disk with nylon brush to remove the settled ink at the inner parts.
6. Wash with Isopropyl Alcohol and then with hot water wipe with dry linen cloth .
7. Clean the air nozzles and pressure regulator using vacuum cleaner and wipe off the dust using
dry cloth.
8. Affix status of cleaning label to the machine.
Operation of Tablet Printing Machine

Equipment Used:
Dyes, Rubber rollers,
5.0 Chemicals Used:

Isopropyl alcohol/Thinner, Printing Ink
6.0 Precautions:
1. Ensure that the equipment is clean before operation

2. Take care that the machine hopper is not over loaded with coated tablets.
PROCEDURE:
Operation of Tablet Printing Machine:

1) Assemble the dismantled and cleaned parts of the Tablet Printing Machine. The parts are
described in .
2) Pour the printing ink into the ink bowl.
3) Adjust the pressure of rubber roller to the die which applies printing ink to the table through
pressure regulator.
4) Feed the required quantity of tablets to the hopper.
5) Switch on the motor and allow the feeding disk to rotate.
6) Adjust the air flow of the nozzle in such a way that a single tablet is fed to the die for printing.
7) Check for proper printing on the tablet surface. If the printing is not ok adjust the pressure
regulator to the required pressure till you get the required printing.
8) Add sufficient quantity of isopropyl alcohol to the ink in the ink bowl to avoid hardening of ink
due to dry ink.
9) Make the relevant entries in the BMR.
10) Intimate the QC dept for necessary checks through intimation slip
11) After getting the necessary approval from the QC through AR, pack the material in suitable
bags and containers. Affix In-process label
12) Transfer the material to packing dept through Material transfer note .
Cleaning of blister packing machine
Equipment Used: Nylon Brush, Air Blower, Lint free wet cloth, Vacuum cleaner.
5.0 Precautions:
1. Switch off the power supply to the Machine and the main.
6.0 PROCEDURE:
1. Remove all the materials of the previous product from the machine and the room.
2. Dismantle the following parts like Hopper , Vibrator Disc , Formation Assembly ,
Cooling Assembly, Sealing Assembly , Printing Assembly.
3. Hopper and Vibrating Disc are first cleaned with Teepol solution and then with purified water.
Wipe them thoroughly using lint free linen cloth.
4. Clean the formation Assembly, Sealing Assembly, Printing Assembly with nylon Brush and
then wipe with lint free cloth.
5. Cooling Assembly clean with lint free dry cloth.
6. Cleaning the body of the machine with vacuum cleaner.
7. Affix the status of the cleaning label.
Operation of blister packing machine

Precautions:
1. Wear Personal protective equipment while operating on blister packing machine.

2. Ensure that Blister Packing Machine is neat and clean before the operation.
3. Each blister should be checked and separated the waste blisters in a container and should be
De-foil the tablets and used the tablets.
5.0 Blister Packing Procedure :
1. Blister packing of tablets should be carried out in an air-conditioned area.

(Temperature of 20 to 30C) and relative humidity at 45 to 55%.
2. The area shall be clean and tidy. All material should be removed of the previous product.
3. For setting blister packing machine follow the guidelines as given hereunder :
4. Switch on the heater and adjust thermostat to provide the heating condition pre determined
for the particular product as per specification.
5. Fix the stereo on the upper roller of the blister packing machine.
6. The auto dispensing unit shall be adjusted only after the forming / sealing / cutting assembly
have attained the right temperature and set as per the specification.
7. Clean the tablet hopper and dispensing roller with the use of acetone. Check that the blister
packing material is consistent with the characteristic of the product in order to ensure that
excessive heating of the product does not take place.
8. Check the type heads of the stereo printing rollers for the over-printing details are correct
and are in accordance with the batch packing order.
9. Get the line clearance from the Q.C. personnel.
10. The first ten or fifteen empty blister should be collected and examined critically for all the
over-printing matter i.e. embossing on the blister rear side, the embossing is B.No. Mfg.
Dt. And Exp. Dt.
11. If these preliminary checks are satisfactory, the blister packing should be continued. At
regular intervals of time (specific for the product being packed) the vacuum test / Leak test
to be done the blisters on at least 2 times in a normal working day.
12. Every blister should be inspected on the belt for detects such as misprint, less number of
tablets, improper seals, and so on.
13. The good blisters as per the product’s specification should be collected after they have been
further packed into carton, tins etc.
14. The rejected blister should be collected and then taken up for recovery.
15. At the end of the working shift, the product left in hopper, vibratory bowl and channel
should be removed.
16. Any blister lying on the packing line should also be removed.
17. The requisite number of reserve sample should be taken from the inspected blisters and
transferred to the QC assurance department and the through in-process intimation slip.
After getting the approval from QC department material is transferred to the final packing
through material transfer note .
6.0 Preventive Maintenance: Once in 6 months.
4. Nylon Brush, Lint free wet cloth & dry cloth, Allen Keys and spanner of relevant size
Operation of blister packing machine
Equipment Used: Nylon Brush, Air Blower, Lint free wet cloth, Vacuum Cleaner,
Spanners and Allen keys of relevant size.
5.0 Chemicals Used: Water, 0.1% Teepol, Thinner
6.0 Precautions:
1. Switch off the power supply to the machine and the main.
7.0 Procedure for Cleaning :
1. Remove all the materials of the previous batch from the machine and the room.
2. Dismantle the feed hopper and vibrating bowl by removing the relevant L-end bolts.
3. Dismantle the parts of SS chute i.e. SS channel, cover plate, Knob and spring loaded SS release
piece.
4. Scrub all the parts with sponge using 0.1% Teepol. Then clean all the above parts with flowing
Of purified water. Allow the parts for some time for drying in the clean and dust free area.
5. Clean the heat sealing rollers with metal wire brush to remove any lumps of molten
polyethylene, dirt and pieces of laminate.
6. Clean thoroughly all the pockets on the heat sealing rollers with the help of a nylon wire brush
and knife.
7. Assemble all the removed and cleaned parts of the machine and affix the cleaning status label.
Operation of strip Packing machine

Machine set-up (Precautions).
1. Ensure that the machine is free from dust and switch off the power supply.
2. Ensure that the left overs of the previous product must be removed.
3. Remove change parts for previous product.
4. Check the change parts of the required product as per the BMR.
5. Mount the sealing rollers so that the centerline of the rollers is exactly above the centerline of
the draw off brushes. Adjustments can be made by studs and nuts on the left hand roller shaft.
6.Adjust parallel positions of right hand sealing roller by regulating sealing roller shaft with the
help of stud and nuts.
7. Check the steorious of the over printing and set to the rollers.
8. Set the temperature of the rollers and check the sealing of the strips in vacuum tester, if any
strip is leaking, again set the desired temperature of the rollers and check the leak test of the
strips. If no leakage is found continue the strip packing.
8. Every strip must be checked and separated if any defect strip is found and collect in a container
and defoiled and the tablets should be re-striped.
9. At the end of the strip packing the machine should be switch off the power supply and remove
the left overs of the product and cleaned the area.
5.Procedure for strip packing.

1. Strip packing of tablets should be carried out in an air-conditioned area.
(Temperature of 20 to 30C) and relative humidity at 45 to 55%.
2. The area shall be clean and tidy.
3. It is advisable to have separate cubicles for strip packing machine to avoid dust
contamination to different products. This is to ensure that there is no mix up of different
products as well as of different batches of the same product.
4. For setting blister packing machine follow the guidelines as given hereunder :
5. Tighten the pressure setting stud for the required sealing pressure until the passing foil is
knurled. (Check impression on foil). Tighten the stud for equalization of pressure
gradually until the foil leaves the sealing rollers in a correctly sealed position all over the
web.
7. After starting the machine ensure that the cutter is functioning properly.
8. Check that one cam pushes the cutter assembly down whereas the other cam imparts
scissor actions to the moving blades of the cutter assembly.
9. Adjust the cutting length of the strip as per product as per BPR.
10. Adjust the level of the bowl and clearance between bowl and top of channel by means of
three leveling screws.
11. For the adjustment of the bowl, ensure that the hopper does not mechanically touch the
vibratory bowl. Control product feed rates to the bowl by means of PVC film joining the
hopper and bowl. Keep the gap between the PVC film bowl 3-4 cm.
12. Adjust the chute in such a way that product fills the channels of the chute.
13. For the adjustment of tablet fall into pockets, loosen the pocket head cap screw on both the
back gears. If the drop of tablet is early, rotate the back gear with pin ring clockwise. If
the drop is late, rotate back gear anti-clockwise.
14. For the adjustment of the foil, the latter should be placed properly to cover the sealing area
of the roller completely. Adjust the smooth foil run by means of screw and nuts on the foil
roll holding shaft.
15. Affix the stereos on batch printing unit drum.
16. Take out the proof of the stereos on the foil in such a way that the impression represents all
the stereos adjuster.
17. Check tablets for identity, batch number and QC approved status.
18. Load the hopper with tablets to be packed and put the product status label on the hopper.
19. Check leak test as per the leak test procedure. Record it at in-process control sat.
20. Check the humidity and record in-process controls. Also check the temperature of sealing
rollers with the help of the suitable thermometer and record it.
6.Packing line set up

1. Check that all material of previous product / batch is removed from the belt. Record it at
in-process control by certifying the line clearance.
2. Bring cartons of the batch to be packed. Check the overprinting details for correctness and
clarity as follows. Attach the checked sample to works order / batch packing record.
3. Check the shipper mark for correctness against marking details.
4. Arrange the packing personnel as per standard packing procedure mentioned in individual
product manual.
5. System of counting to be followed as per Batch Packing Record.
6. System of carton filling as per Batch Packing Record.
7. System of shipper filling as per Batch Packing Record unless and until one layer is
completed, second layer must not be started.
7.Product Change over :
1. Ensure all the switches are put off and the must be cleaned and dried.
2. Remove carefully the parts of the machine like Hopper, Vibratory bowl and rollers.
3. Hopper and Vibratory bowl should be cleaned with water at wash area, and keep at dried
and cleaned area for drying.
4. Ensure that all the left overs of the previous product must be removed from the room and
cleaned.
5. The removed rollers must be cleaned and store appropriately.
2. All fractional parts of the machine apply Lubricated oil like Servo Engine oil for smooth
functioning of the machine.
3. The machine should be cleaned with dry cotton and fix the required rollers carefully and fix
the Hopper and Vibratory bowl.
4. Ensure the functioning of the Compressor and maintain in good condition.
5. Load the tablets into the Hopper and start the machine and set the machine to get the
required parameters of the tablets.
8.Preventive Maintenance: Once in 6 months.
Cleaning of double cone blenders I & II

Equipment Used: Nylon Brush, Air Blower, Lint free wet cloth,
5.0 Cleaning Agents: Water,

4. Ensure that the equipment is properly dried after every cleaning operation.
5. For every product change over the equipment should be cleaned.
6. Dismantling - a. Remove the safety guard of the blender
b. Remove the circular lid and gasket by unclamping wing nuts.
7. Cleaning external surfaces – Clean the body of the blender with dry duster first and then with
moist duster and again wipe with a clean dry cloth.
8. Clean the inside surface of the blender with DM water and using a nylon brush.
9. The cleaned water should be collected into a tub and drain the water.
10. Use hot water if any materials are sticky to the blender.
11. Clean the gasket, rectangular lid and valve lid with plenty of DM Water in the wash area.
12. Inform the Q.C. to collect the rinse water / swab for testing of cleaning.
13. Drying – Wipe the blender using a clean lint free cloth.
14. If the testing results are complies fix the lids and paste status label of the equipment.
15. If the testing results are does not comply, the equipment should be cleaned thoroughly and
carefully until obtain the test results are come down to a desired levels.
Operation of double cone blenders I & II

Precautions:
5.0 PROCEDURE:
1. Adjust the angle of the blender with the help of a moving wheel to a required position for
convenience in loading of materials.
2. Ensure the bottom lid should be closed and checked.
3.Load the materials from the container into the blender as per the sequence specified in the
individual BMR.
4. After loading the materials, close the upper lid of the blender.
5. Put the safety pin on the lid and fit it properly within its groove.
6. Lock the blender lid by moving the wheel in clockwise direction.
7. Switch on the equipment and start the blending for required time mentioned in the individual
BMR.
8. Record the blending time in the respective BMR.
9. After blending time is completed. Switch off the equipment.
10. Adjust the position of the blender at the required angle for convenience in unloading the
materials.
11. Unlock the safety pin and remove the lid from the blender.
12. Unload the blended materials into a cleaned plastic containers and affix the status label..
13. Inform the Q.C to collect the sample of the blend.
14. Dismantled and Clean the blender as per standard of cleaning procedure.
Cleaning of manual capsule filling machine
Equipment Used: Nylon Brush, Air Blower, Lint free wet cloth.
5.0 Chemicals Used: Water, 0.1% Teepol.
6.0 Procedure for cleaning.

1. Dismantling and remove the parts like Powder tray , Sliding attachment plate,
Top main plate, Sliding plate , Eccentric bolt and Hand lever.
2. Cleaning of dismantled parts – Clean the above dismantled parts by soaking for 5 to 10
minutes in 0.1% Teepol solution and scrubbing with soft clean nylon brush. Wash with a
jet of potable water followed by washing with filtered DM water.
3. Cleaning of capsule plates – Soak capsule plates in hot filtered DM water for 5 to 10
minutes and clean holes using clean hard nylon brush and 0.1% Teepol solution. Wash
with jet of potable water followed by rinsing with filtered DM water.
4. Confirming effectiveness of cleaning – Send the DM water rinse of the above parts to the
QC department to confirm the absence of previous product.
5. Cleaning of machine body – Clean with 0.1% Teepol solution and scrub with soft nylon
brush. Rinse and thoroughly clean with filtered DM water.
6. Drying – Wipe and dry the cleaned parts as mentioned in step 3 using a clean dry lint free
duster. Air dry the sliding and capsule loading plates in an SS tray.
7. Assembling – Re-assemble all the parts of the machine carefully checking for correctness
of assembling.
8. Fix the ‘cleaned’ label. Cover the machine with a suitable cloth cover.
Operation of manual Capsule Filling & Sealing Machine

Precautions:
1.Wear gloves wherever chemical is used for cleaning to avoid bodily contact.
2.Spillage of Chemicals and Water on electrical parts like motor and starters are to be avoided.
3.Ensure that the equipment is properly dried after every operation.
7.0 PROCEDURE
1.Fill in the blended material in to the containers of manual capsule filling machine
2.Use swiper and clear off the surface by moving this swiper from left to right on the capsule
filling machine.
3. Ensure that the material is properly filled in the capsules kept down below.
4. Ensure the right size of capsule is kept in the prescribed containers .
5. Take the material out and check the weight size and shape for uniformity.
6. Make relevant entries in the capsule filling record.
Cleaning of Starch paste, Coating solution preparation vessel
Cleaning Agents: DM Water.

1. The vessels should be taken to the washing area.
2. The vessels are cleaned with flush of DM Water to remove the traces of the previous product.
3. If any paste is sticking with the vessel, use hot water for cleaning.
4. Clean thoroughly with DM Water until the equipment is cleaned.
5. Inform to Q.C to collect the rinse / swab for testing of the cleaning.
6. Allow the vessels for drying at a clean area.
7. If the test results are complies according to the cleaning procedure, the vessels are ready to use
for the further batches.
8. If the test results are does not comply, the vessels are to be cleaned again until to remove the
traces of the previous products.
9. The small size vessels and scoops and spoons are kept in a poly cover.
10. The vessels are affix a status label of cleaning.
Cleaning of Colloid mill

4.0 Cleaning Agents: DM Water. 1 % Teepol solution.
1. The colloid mill should be taken to the washing area.

2. The mill is cleaned with flush of DM Water to remove the traces of the previous product.
3. If any paste is sticking with the vessel, use hot water for cleaning.
4. Clean thoroughly with DM Water until the equipment is cleaned.
5. Prepare 1 % solution of Teepol solution as add 200 ml of Teepol to a bucket of approximately
20 Lts. Of DM Water.
6. Pour the above cleaning solution into the hopper of the colloid mill and operated the mill for
recirculation for about 15 minutes.
7. After 15 minutes recirculation drain the cleaning solution.
8. Pour DM Water into the hopper and operate the mill for 15 minutes for recirculation.
9. After 15 minutes drain the DM Water.
10. Pour again DM Water into the hopper and operate the mill for 15 minutes for re circulation.
11. Drain the recirculated water.
12. Inform to Q.C to collect the rinse / swab for testing of the cleaning.
6. Allow the mill for drying at a clean area.
7. If the test results are complies according to the cleaning procedure, the mill is ready to use
for the further batches.
8. If the test results are does not comply, the mill is to be cleaned again until to remove the
traces of the previous products.
9. The nozzles of the mill should be covered with poly covers.
10. The mill is affix a status label of cleaning.
Working procedure for packing department
Precautions:
1. The works order is sent to stores one day in advance to confirm the availability of material.
Packaging material from stores is issued.
2. The following points are checked while issuing the material :
1. The name of the packing material
2. Passed labels and details of A.R. Nos.
3. Weights / quantities of packing material as per works order.
3. Check the release slip for packing of bulk finish is received from QC. This report of in-process
product release of goods is available in the QC Department.
4. Gross weight of individual container is checked by the production officer / supervisor of the
packing department.
5. Check carefully the over printing of the packaging material with corresponding to the BPR.
6. All the overprinted cartons / catch covers / labels are checked for clarity before use. Bulk finish
product and the foil is taken to the respective work center after giving certification for line
clearance by the OC officer.
7. If any packing material is not legible, reject the material and is destroyed under the
supervision of the production officer.
8. First shipper of the batch is checked by packing supervisor for the arrangement of the shipper.
5.0 Process of Packing.

1. Start the packing after given the line clearance by the Q.C. Officer.
2. Start the packing according to the packing of the individual BPR. Such that carton packing ,
leaflet arrangement, shrink wrap and shipper packing.
3. Entries must be entered in the BPR The shippers are pasted one label with details.
4. Control samples collected from the packing line of the product by the Q.C. Officer and are kept
in Control samples rack.
5. Packed shippers are kept on the pallets in the packing stored area near the work centre
6. The shippers are then sent to bonded stores, when the Q.C is given permission for ready for
dispatch.
7. If the last shipper is half filled at the end of the batch then the quantity of the cartons packed is
corrected for the actual quantity. Also the number of cartons is encircled in bold figure.
8. This shipper is checked and signed by the officer / supervisor. Finished goods are handed
over to stores for dispatch.
9. If any packing material is additionally taken from the Stores, the entries must be made in the
BPR. And is approved by Production manager.
10. Balance packaging material is returned to stores duly authorized by the department head. In
case of any material rejected on-line the same is informed to QC through stores by on line
Rejection Intimation Memo.
11. QC then gives complies certification or rejection and the same is returned to stores.
12. De-foiling operation on strips / blisters is carried out as per SOP.
13. Disposal of waste is done as per the SOP procedure.
14. BPR duly completed by the concerned production officer. The BMR is checked by
The Head of production department and handed over to quality assurance for the review.
16. The Q.C. is sent a slip for release for dispatch after the review of the BMR and BPR.
17. The stock is handed over to the Stores for Dispatch.
Procedure for Over Printing Control
Precautions:
1. Ensure that the information on packing legible.
2. Ensure that it allows identification and traceability
3. Get necessary overwritten approval
6.0 Procedure:
1. The text i.e. B.No. Mfg. Date, Exp. Date, M.R.P. is supplied by the production supervisor
to the overprinting section. A specimen of the Text overprinted is verified by the
production supervisor and rechecked by the Q.C in-charge and finally verified by the
quality assurance department.
2. The same text is recorded, signed and kept in BMR and BPR. Sorted quantity is kept under
lock and key in the store segregating to avoid any mix-up of B.No. or of same color
packing supplies. Overprinted text is approved by quality control / quality assurance.
3. At the time of starting the blister packing / strip packing, the initial trial should be taken on
the blister / strip packing machine without tablets. The printing matter is checked by the
operator against the BMR. If the matter is relevant to the BMR. Then start the blister /
strip packing with tablets for few blisters / strips and switch off the machine.
4. The initial blisters / strips with the relevant BMR and over printing book should be sent to
the Q.C / Q.A department for checking and get the approved signature for the over printing
matter.
5. Each blister / Strip is to be checked the printing matter and tablets fulfillment. If any one
blister / strip is deviated that is to be separated and defoiled.
6. When the blister / strip packing is completed, the area and equipment are cleared.
7. The stereos of the strip packing machine are destroyed in presence of line supervisor.
8. The embossing type stereos should be thoroughly cleaned and preserved in the respective
boxes.
Reconciliation of Packing Material
Precautions: 1. Ensure that the information on packing legibly written

6.0 Procedure:
1. At the end of the packaging operation for any given batch, determine the number of
Cartons / shippers used for the batch.
2. To this quantity, add the following quantities of overprinted cartons/shippers.
3. Number of overprinted cartons taken as samples for the batch by quality control
4. Number of overprinted cartons/stenciled shippers found rejected on line.
5. Number of overprinted cartons affixed on packaging record as sample.
6. Balance quantity of good overprinted cartons/shippers.
7. The total quantity of overprinted cartons/shippers calculated in the manner mentioned above
should be compared with the total quantity of overprinted cartons/shipper indented.
8. The variance should be noted.
9. The balance good and/or rejected overprinted cartons/shippers should be immediately destroyed
under proper supervision and this destruction should be recorded.
10. Variance should lie within the limits given in the individual BPRs.
11. The variance should be noted in the respective BPRs.
12. If the variance is out of the limits of the BPR, attach a separate sheet to the BPR with relevant
entries of the utilization of the materials.
13. These variances should be approved by the Production Head and Head of the Quality
Assurance.
Packing Slip on Final Shipper

Precautions: 1. Ensure that the information on packing legibly written
7.0 Procedure
1. Shipper Packing slips are contains the information regarding the Product Name, B.No. Mfg. Dt.
Exp. Date , Quantity packed and Wt. of the final packed shipper. .
2. At the time of packing starting, the initial shipper should be carefully checked the packing and
close the shipper and weigh the shipper on the calibrated platform balance in the presence of
Q.C. supervisor.
3. This slips are getting from the QC department against each BPR quantity.
3. This slips are checked by the packing supervisor and Quality Assurance Officer.
4. Packing supervisor on receiving the packing record along with the packing slips.
5. Paste the packing slip to each packed shipper.
6. Packaging supervisor shall record the relevant entries in the BPR.
7. At the end of the packing operation, reconcile the number of shippers, cartons, etc.. used for the
batch of the product.
8. Extra packing materials of B.No. printed Slips, Innor cartons and Outer cartons should be
destroyed.
9. The extra packing materials like shippers should be returned to stores.
10. The relevant entries should be entered in the BPR.
Master Batch Manufacturing Record

Procedure :
1. Check the BMR thoroughly by the Competent Technical Staff such as Name and strength of
the product along with dosage form (if it is pharmacopoeial product under trade name, both
names will be given)
2. The name and weight/measure of active ingredients per dosage unit or per unit weight/measure
of the product and total weight/measure of any dosage unit.
3. A complete list of all the ingredients to be used in the manufacture of the product indicating any
special quality characteristics.
4. An accurate statement of weight/measure of each ingredient (same weight system should be
used) required as per formula of dosage form and the weight/measure actually to be used
(e.g. overages to compensates losses during storage).
5. A statement of theoretical weight/measure a appropriate phases of processing.
6. A statement of theoretical yield including permissible limits beyond which investigation is
required.
7. The Master BMRs are the replicates of the regular use BMRs.
8. The BMR must be approved by the Works manager and Q.A. manager and keep in a secured
and traceable place.
9. For regular BMRs should be taken the copies of the approved MBMRs only.
Man power Entry and Exit Procedure

Entry procedure :
1. Man power entry is different from the material entry.

2. Enter into first change room.
3. Remove the street foot wear and keep in the specified space
4. Wash hands in wash basin using detergent.
5. Dry hands with a clean towel.
6. Move into the second change room
7. Wear clean specified company foot wear
8. Wear appropriate apron / uniform, cap, gloves, nose mask and enter into the main
production area.
Exit procedure :
1. Please follow reverse order and keep the used aprons / uniforms , chapels, caps and nose
masks in the specified place.
2. Wear street foot wear and come out of the change room.
Cleaning of semi-automatic capsule filling machine
PROCEDURE FOR PRODUCT TO PRODUCT CHANGEOVER
1. Dedusting external surface – Use a clean nylon brush and vacuum cleaner. Remove the
filter bag of the vacuum placed behind the machine.
2. Dismantling -Remove :Filling and loading turntables, Pusher slide,
Rectifier, raceway with guide block , Magazine , Drug hopper, auger and stirrer
Peg ring plate , Partial fill attachment,Collect all these parts in a
suitable SS container.
3. Cleaning of parts – Clean the above parts by washing with 0.1 % Teepol solution and
scrubbing with soft clean brush. Rinse with a jet of potable water followed by rinsing
with 5 micron filtered water.
4. Cleaning of capsule plates – Capsule plates are soaked in hot 5 micron filtered water for
5-10 min. The holes are cleaned using 0.1% Teepol solution. Rinse with jet of potable
water by dipping in 5 micron filtered water.
5. Cleaning of machine body – Clean with 0.1% Teepol solution and scrubbing with soft
nylon brush. Clean with potable water.
6. Confirming effectiveness of cleaning – The DM water rinse of product hopper and
capsule plates is sent to QC department to confirm absence of previous product.
7. Drying – The cleaned dried parts as mentioned in step 2 are wiped and dried using a
clean lint free duster. The capsule plates are air dried and are stored in the SS trolley.
8. Assembling – Reassemble all the parts of the machine carefully checking for the
correctness of assembling and free motion of moving parts. Replace the filter bag in
the vacuum can below the machine with a clean filter bag.
NOTE :
1. Step 6 is validatory exercise to be conducted once in six months at the time of product
changeover.
2. Fix the ‘cleaned’ tag with date, previous product and initials.
3. Replace vacuum filter bag from vacuum can behind machine every day at the start of
filling.
4. Dry clean the machine with clean lint-free duster, if it is not used within 24 hours.
B. PROCEDURE FOR BATCH TO BATCH CHANGEOVER
1. Remove powder below the powder filling turntable.

2. Dedust external surface of machine with vaccum cleaner.
3. Dry clean the machine with clean lint-free duster.
4. Oil the different moving parts of machine on loading side.
5. Dry clean the partial fill attachment by wiping with a clean lint free duster.
PROCEDURE TO BE FOLLOWED FOR CLEANING AT END OF SHIFT :
1. Remove empty capsules empty capsules from empty capsules hopper.

2. Remove blend from powder hopper.
3. Dedust external surfaces with vacuum cleaner and clean with clean lint-free duster.
4. Clean the capsule loading plate as per procedure A step 4.
5. Clean the partial fill attachment as per procedure A, step 3.
6. Cover the machine with suitable cloth cover.
Operation of semi-automatic capsule filling machine

Precautions :
1. Trained operator only eligible for the operation.
2. Ensure correct assembling by moving the wheel manually to check free movement of all
loading parts and then switch on.
3. In case of any abnormal sound from machine during its operation stop the machine and
report to maintenance.
4. Ensure the clean and dry accessories in the following order :
Capsule loading assembly consisting of magazine, pusher plate, Base plate , Hopper shoe,
Modified auger, Appropriate spacers in the light house and below the turn table,
Partial fill attachment and Peg ring plate in closing unit.
5.0 OPERATION PROCESS

1. Ensure that all parts of the m/c are cleaned as per standard procedure.
2. Load the empty capsules in hopper for empty capsules. Load the blend into powder
hopper.
3. Start vacuum and compressed air. Switch on the power supply and switch on the mains of
the machines (lever situated behind the machine). Switch on the machine by pushing
control mains button (situated on panel in front of machine).
4. Fit the capsule ring on loading turntable (i.e. RHS turntable) for loading empty capsules.
Start loading by pushing ‘ON’ the start button for loading empty capsules.
5. On the completion of one revolution of capsule ring the loading stops automatically. Turn
the ring 2-3 complete rotations to spare cap and body.
6. Vacuum supply should be adjusted to (limits 15” – 20” of Hg) separate cap and body of the
capsules. Compressed air required to operate the machine and for closing unit should be
(limits 70 – 100 psi).
4. Separate the cap and body rings. Keep the body ring with PFA on the turntable. Push the button
to start powder filling. Scrape the excess powder from the PFA. Release the powder in the
capsule body by de-locking and tapping PFA (with the help of Teflon block). Remove PFA
from body ring and place it inverted on the table.
5. Place cap ring on the body ring partially filled with the blend. The joined loading ring is placed
on vertical closing unit and closing unit is pushed manually into the closing structure, where
capsules get locked. The closing unit is pulled out and fitted 70 – 80ºC to eject the filled and
locked capsules. The capsules are collected into a suitable container kept below the chute.
6. Check the weight of the 20 Capsules and individual weight of the 20 Capsules, If the limits are
not within the specification of the individual monograph of the BPR. Set the machine fill
weight according to the BPR. Intimation send to Q.C. for collection of the Samples.
7. Check the weight of 20 Capsules and individual weight of the 20 Capsules, If the results are
within the limits, the results are recorded in the in process sheet of the BMR. And continue the
filling.
8. Check the 20 Capsules weight at every 30 minutes interval and DT at every 1 hour. And
record the results in the in process in the BPR.
9. After completion of operation switch off the machine by pressing the switch marked
‘Emergency’ lever (situated behind machine), power mains vacuum and compressed air supply.
6.Preventive Maintenance: Once in 6 months.
5. Remove the cover of loading assembly by loosening 3 screws on the back with the help of
screwdriver.
6. Remove the pusher slide by loosening two screws attaching it to raceway with the help of
Allen key (5mm Allen key).
7. Remove the raceway by loosening two screws with help of Allen key (6mm Allen key).
8. Remove the magazine by loosening two front screws with the help of Allen key
(6mm Allen key).
Stacking of shippers
Procedure :
1. Arrange the shippers in a staking of 5 / 6 stacks.

2. After 2 hours of the staking, observe the stack and carefully observe the bottom of
the shippers in a stack.
3. If any shippers are bend or un-even in the stack, reduce the stack size.
4. Inform the observations to the Q.C. personnel.
5. If the shippers are not bearable of the burden of the weight, the shippers are not fit for
the particular product and change the shippers with proper strength of the shippers.
Policy on replacement of punches

Procedure :
1. At the time of procurement of punch-dye sets, the production department will raise an
indent for the purchase of punch-dye sets and submit it to the engineering department.
Care will be taken to indent for ordering for 10% extra number of sets so that any
damaged sets can be replaced during the life cycle of the punch-dye sets.
2. Incoming Inspection – Engineering department will receive the punch-dye sets from the
supplier and subject these punch-dye sets to 100% inspection. Any sets not conforming
to the specifications will be immediately returned to the supplier for the replacement.
Only the Inspected and good sets will be issued to the production department.
3. On receipt in the department, the production supervisor will also inspect the punch sets
and then only he will allow the use of the same.
4. Each punch – die set will be stored in separate wooden box in the following manner.
a. All the individual punches and dyes will be smeared with thick machine oil if they
are intended to be used after a long time (i.e. more than a month) otherwise all the
punches and dyes will be smeared with light liquid paraffin.
b. While placing the punches and dyes into their respective groove, care will be taken
that the punches or dyes do not hit against each other.
c. Each box will have a label indicating the following:
(i) Name of the product/ products for which the sets will be used.
(ii) Name of the machine on which the punch-dye set will be used.
(iii) Date of manufacture.
(iv) Name of the manufacturer of the punches and dyes.
(v) No. of upper/lower punches and dyes.
(vi) Key No. of the lock which is installed on the box.
5. Each punch-dye set will not be used after the compression of 1000 million tablets or if
the physical condition of the punch set is such that it cannot be used for compression
(whichever is earlier).
6. To ensure this a separate record will be maintained for each punch-dye set which will
incorporate the date of commencement of use, year-wise use of the punch sets an
cumulative number of tablets compressed with the punch-dye set.
7. The record will be maintained for keeping in view the lead-time to procure the new
punch-dye sets.
Cross contamination control

Procedure :
1. Materials must be procured from approved suppliers and inspect their facilities periodically,
which is to identify any potential source of cross contamination of substances supplied.
2. If the manufacturing location is manufacturing more than one item, periodically the QC
department will attempt to identify the presence of the contaminant in the item purchased.
3.The procedure followed in the production of packing components, particularly the intimate
packaging items is carefully studied by the QC team, essentially with a view to track any
residual contaminant e.g. mould lubricant, metal filing etc.
RECEIVING AND STORAGE
1. There is a very strong possibility of improper storage, spillage.

2. Attention needs to be paid in the transporter’s warehouse and the customs hold area.
3. It is essential to request assistance from QC personnel for such sampling.
4. The stores personnel will verify with QC suitability of containers if the contents from the
original container are required to be transferred.
DISPENSING
The SOP for dispensing of materials needs to be religiously followed to prevent any cross
contamination.
COMPOUNDING
Apart from the prescribed SOPs, supervisors concerned will pay attention to the condition of
garments worn by the operators and the cleanliness of the various accessories, including
scoops, spatulas etc. Particular attention will be required to ensure that the crevices, gaskets etc.
are free from any contaminant. Dust control equipment must invariably be validated to confirm its
capability to pick up errant material. Periodic chemical testing of the rinse from cleaned
equipment will further increase the confidence of cross contamination control.
WORK IN PROCESS
These areas should be secure and accessible only to the authorized personnel. Sampling can be
carried out only by and under instructions from technical manager or authorized personnel.
Standard good manufacturing practices (GMP) and routine sanitary control and inspection will
eliminate potential hazards. Prolonged hold needs to be discouraged / eliminated.
PACKAGING
Strict observation of the SOP during the intimate packaging will not permit any cross
contamination.
The above is only illustrative guidelines and is only through understanding and committed
observance of prescribed procedures that we can produce a product without contamination.
Environmental monitoring
Procedure :
1. Every section except washing area the environmental control shall be maintained and recorded
time to time along with dates and concerned processing of the product.
2. The room temperature, positive pressure, reading and the humidity must be noted down in this
respective records with signatures.
3. The AHU validations shall be conducted by the external agency, once in a year.
personnel certification.
4. The AHU ducts shall be cleaned once in fortnight.
5. Monthly once fumigation should be conducted in the processing areas.
6. Environmental monitoring tests of microbial plate count test for aerobic counts shall be
Conducted on every month and records should be maintained in the Microbiology Department.
7. If any abnormal conditions were found in the respective sections, immediate corrective action
plan must be implemented by Fumigation.
Personal hygiene, clothing and dress code
Procedure :
1. All the employees in the factory are mandatory for medical check up for once in a year and
medically examined by a qualified medical practitioner and records are maintained.
2. All employees should be free from contagious and infectious diseases to avoid the product
contamination.
3. The company takes care of the employees in case of accidents by provided by FIRST AID BOX
with necessary medicines.
4. The employees must wear the proper company dress before entering into their respective
sections.
5. Every lady employee must leave their ornaments, flowers or bangles in their respective lockers
and wear the company dress before entering into the manufacturing premises like production,
packing areas.
6. The company dress must be kept in their respective places where the company had provided in
the dress change rooms.
7. The organization of pharmaceutical industry management shall provide separate dress change
rooms for ladies and gents.
8. The dresses must be sent for washing and ironing before the day of weekly off.
9. The washed dress shall be provided twice in a week from the house keeping in-charge.
Note : Personnel and administrative incharge shall give the instruction to the gents that they have
to avoid to wear “JEANS” because JEANS will improve the contamination.
Production of DM Water
PRODUCTION PROCESS
INTRODUCTION :
The process of producing de-mineralised or de-ionized water by pure water process is

basically a three stages. The Raw / Potable water to be passes through comprising a Carbon
filter, cation exchanger followed by an anion exchanger. The resultant water is substantially free
from dissolved solids. It would be theoretically possible to produce very pure deionised water.
The above water produce through mixed bed deionizer produces very pure water quickly.
PROCESS: Connect the inlet tube to raw water line and lead the other tubes to a drain.
Carbon Filter : Open valves WI (1) and WO (4).

Water enters the filter at the top and leaves and the bottom.
DM – 150 : Open valves (3) and (6).

Start the water supply.
Switch on the conductivity meter.
When the conductivity indicates is less than 30 uS/Cm,
the water out let tube connected to the mixed bed.
MB – 150 : Open valves (1) and (3).

Water enters the mixed bed at the top and leave at the bottom.
Switch on the conductivity meter.
When the conductivity indicates is less than 4.0 microsiemen/cm,
the treated water can be collected for use by leading the treated water outlet
tube to container / storage tank for collection.
UV : The stored water is passes through the UV at production room. The water is
Collected here for production operations and samples for testing.
RE-GENERATION PROCESS
When the conductivity increases to 4.2 microsiemens / cm and above, it is an indication that the
unit is exhausted and requires regeneration.
Solution for Cation bed 2.7 Lts. HCl 8.0 Lts DM Water
Solution for Anion bed 800 Gms. NaOH 10.5 Lts. DM Water.
0.53 Lts. HCl 2.5 Lts. DM Water.
Solution for Mixed bed
450 Gms. NaOH 6.0 Lts. DM Water.
Note : 1. One time Re-Generate all the beds like Cation, Anion and Mixed beds.
2. Three times Re-Generate only Cation and Anion beds. As follows repeatedly.
RE-GENERATION PROCESS: for DEMINERALISER DM - 150
ACID INJECTION : Close the raw water tap. Fill the acid solution in the tank.
Open valves 1 and 4. Continue till the acid solution is exhausted.
It will take 20 – 25 minutes.
ACID RINSE : Fill the tank with 16 Lts. Of DM Water.

Continue the above operation till the water is exhausted.
ALKALI INJECTION : Close 1 AND 4 . Fill the caustic soda solution in the tank.
Open valves 2 and 5. Continue till the caustic soda solution is
exhausted. It will take 20 – 25 minutes.
ALKALI RINSE : Fill the tank with 24 Lts. Of DM Water.

RE-GENERATION PROCESS: for MIXED BED MB - 150
BACK WASH : Open 2 and 9 valves
ALKALI INJECTION : Fill the caustic soda solution in the tank.

Open valves 5 and 7. Continue till the caustic soda solution is
exhausted. It will take 10 – 15 minutes.
ALKALI RINSE : Fill the tank with 14 Lts. Of DM Water.

ACID INJECTION : Fill the acid solution in the tank.
Open valves 6 and 8. Continue till the acid solution is exhausted.
Close valves 6 and 8.
ACID RINSE : Fill the tank with 5 Lts. Of DM Water.

FINAL RINSE : Close valves 2 and 5 .

Open the valves 3 and 6 and the raw water supply.
After 15 minutes switch on the conductivity meter.
If the quality of water is acceptable, start collecting the water,
Otherwise drain the water for some time to acceptable quality like
pH, Conductivity and Chlorides.
Operation and calibration of balance (Table) 3 Kg

Precautions:
1. Ensure that the balances must be free from dust.
2. Place the balances on shock proof basement.
3. Avoid the spillages on the balances when the time of dispensing.
4. Ensure the spirit level in the centre of the ring provided in the balance.
5. Record the every day calibration details.
6. Ensure that the standard weight must be periodically calibrated by out side agency.
5.0 Procedure:
1. Switch on the main and the stitch on the balance.

2. Wait for few minutes for display comes to 0.00
3.Calibrating the balance every day by putting below weights and maintain the record.
Std. Weight Checked Observed Weight %Deviation

100 g 0.2 %
500 g 0.2 %
1 Kgs 0.2 %
2 Kgs 0.2 %
4. Place the tare on the platform of the balance.

5. Record the tare of the weight.
6. Add net weight to the tare.
7. Transfer the material in the tare up to reach the gross wt. ( Tare Wt. + Net Wt.).
8. Remove the material from the balance.
9. Clean the platform of the balance.
10. Weigh the remaining material and put a tag and place the material in the stores.
6.0 General care & precautions
 Proper handling of the instrument.

 Do not load heavy weights, which are out of its capacity,
 See that the instrument is not exposed to the vibration forming devices.
7.0 Maintenance / repairs
If the instrument does not produce required calibration results or its response is poor then it should
be labeled “FAULTY” and should be repaired or serviced.
FREQUENCY : Daily.
AHU Filters Cleaning Procedure

Precautions:
1. Ensure that the all AHU switches must be off.
5.0 Procedure:
1. Switch off the main and all the switches of the AHU.
2. Remove the filters from the AHUs.
3. Close the opening of the AHUs to prevent the entering of the insects.
1. Flush with air to remove dust particles.
5. Clean with Water.
1. Clean with soap solution.
2. Keep the Wet Filters for drying.
3. After drying the filters are to be fixed.
6.0 Frequency : Once in Fortnight.
Operation and Cleaning Procedure for Dispensing booth

Operating Procedure:
1. Ensure that the all Dispensing booth is always clean.
2. Switch on the main electricity supply of the booth.
3. Switch on the light in the dispensing booth.
4. Switch on the circulation of the air.
5. Observe the magnehelic gauge reading, the needle should be coincide with the reading 1.
It is equivalent to 10 Pascals.
2. Balances should be calibrated every working day in the dispensing booth and recorded.
3. Open and Dispense the material in the dispensing booth only.
4. Collect the Q.C. Sample also in the Dispensing booth only.
5. Clean the dispensing booth with clean cloth or cotton after the work is completed.
6. Switch off the light, circulation of air and the main power switch.
5.0 Procedure for Filters cleaning :

1. Switch off the internal and main switches of the Dispensing booth.
2. Remove the pre filter, HEPA filters and Exhaust filters from the Dispensing booth.
3. Flush with air to remove dust particles.
5. Clean the filters with water.
4. Clean the filters with mild detergent soap solution.
5. Keep the filters in the clean area for drying.
6. After drying the filters are to be fixed.
6.0 Frequency : Once in a month / Whenever the needle is not moving
( it indicates the chocking of the filters).
Polishing procedure for filled capsules

Operating Procedure:
1. Ensure that the polishing area is clean.
2. Remove all left overs of the previous product.
3. The polishing are should be cool.
4. Place the Cloth towels on the SS Table as like a cloth bed.
5. Workers should be wear hand gloves, nose masks, head cover and apron.
7. Take some quantity of the capsules on the cloth bed and rub the capsules smoothly on the
cloth with glove hands.
8. With continues smooth rubs the capsules are becoming shining and free from dust like powder
9. The shined capsules are collected in a plastic container .
10. The container should be labeled with product details and status of the capsules.
11. The relevant entries should be made on the BMR.
12. The cloth towels should be removed after some time and use washed cloth for polishing.
13. The removed cloth should be washed and allow for drying in a clean area.

Production Sops

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Production Sops

Uploaded by

Copyright:

Available Formats

INDEX FOR SOP – PRODUCTION

S.No. TITLE SOP. REF. No.

26. Operation of strip packing machine PR/SOP/26

4.0 Cleaning Agent : DM Water.

5.0 Cleaning Procedure :

6.0 Method of operation / working

Cleaning of RMG Mixer

4.0 Procedure for Cleaning :

Operation of RMG Mixer

Operation and calibration of balance (Platform)

5.0 Calibration Procedure:

1. Switch on the main and the stitch on the balance.

Std. Weight Checked Observed Weight %Deviation

6.0 Dispensing Procedure:

1. Place the tare on the platform of the balance.

6.0 General care & precautions

 Proper handling of the instrument.

7.0 Maintenance / repairs

Calibration Frequency : Daily.

Cleaning of Fluid Bed Dryer

4. 0 Procedure : Cleaning procedure used for trolley bowl.

4.1 Cleaning procedure used for trolley bowl.

4.2 Washing procedure used for filtering cloth.

1. Take about 50 liters of Manzeera water into a plastic drum.

1. For every change of the Product.

6. PROCEDURE FOR MAINTENANCE FBD:

1. Ensure the temperature controllers are in good condition.

Operation of Fluid Bed Dryer

1. Remove feed hopper and lid.

Cleaning Tablet compression Machines I & II

Chemicals Used: Kerosene or acetone and thinner,

6.0 Cleaning procedure for Punching Machine :

1. Switch off the machine and mains of the power supply.

1. Switch off the machine and mains of the power supply.

8.0 Procedure for Cleaning of Punches and Dyes :

1. Switch off the machine and mains of the power supply.

9.0 Fix the Punches and Dyes to the Compression Machine :

1. Switch off the machine and mains of the power supply.

10.Maintenance of Compression tooling :

Operation of Compression Machines – I & II

Utensils Used: Scoops and feeders, punches and dyes.

5.0 Lubricants Used: Food Grade Lubricants.

7.0 Expected Problems:

8.0 Operation of the Compression Machine :

9.0 Preventive Maintenance: Once in 6 months.

Procedure for in-process Quality Testing

5.0 Frequency of the IPQC :

1. Two times in a Day session : Normally between 9.0 AM to 10.0 AM.

2. Leak test frequency

Storage of in-process tablets and granules

4.0 Equipment Used: Polythene bags and suitable containers.

7.0 Day Storage Procedure :

1. A requisite number of aluminum containers, each containing a polybag, will be pre-weighed

Cleaning of conventional coating pans

5.0 Chemicals Used: DM Water.

7.0 Procedure for cleaning of the Coating Pans :

A. Cleaning Procedure for batch to batch changeover

1. Dismantling – Remove the blower pipe from the body.

B. Cleaning Procedure for product to product changeover

1. Dismantling – Remove the blower pipe from the body.

Operation of conventional coating pan

Hot air blowers, Spray gun, polythene bags

5.0 Chemicals Used:

1. Ensure that the Equipment is cleaned and dried before operation.