sop for gmp checks in production tablet

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sop for gmp checks in production tablet

Purpose
1.1 To lay down a procedure for GMP Checks in Tablets section of production department.
2.0 Scope
2.1 This SOP is applicable for GMP Checks in Tablets section of production department, in ABC Pvt. Ltd.
3.0 Responsibility
3.1 Production/QA Supervisor To follow the Procedure & Execute the activity.

Stores Supervisor To execute the activity as per SOP.
Head Production To Implementation of SOP
Head QA To Review and approved the SOP

4.0 Accountability
4.1 Production Head is accountable for compliance of this SOP.
5.0 Procedure
5.1 Manufacturing
5.1.1 Area : Ensure that
5.1.1.1 Doors are always kept closed.
5.1.1.2 No unauthorized person is allowed in the area.
5.1.1.3 AHUs are switched “ON” before the work starts.
5.1.1.4 Area is free from flies, Mosquitoes, cockroaches and rodents.
5.1.1.5 Area is free from cobwebs, dirt and stains.
5.1.1.6 Floor is clean.
5.1.1.7 Area is kept neat and free from unwanted materials.
5.1.1.8 Plastic/SS dustbins with polythene lining and lids are used.
5.1.1.9 Drains are sanitized.
5.1.2 Equipment: Ensure that :
5.1.2.1 Steam safety valves and pressure gauges are working satisfactorily.
5.1.2.2 Equipment is in proper working order and operating instructions are strictly followed.
5.1.2.3 It is repaired for any major or minor defect should be recorded in equipment history card.
5.1.2.4 Equipments are covered properly when not in use.
5.1.2.5 All equipments are closed with lids except when adding materials.
5.1.2.6 Cleanliness of the equipment is ascertained before and after use. No traces of previous product should be present.
5.1.2.7 Rinse water analysis has been done and equipment is released by Q.C. before its use in case of product change over.
5.1.2.8 The written cleaning procedure is followed and the cleaned equipment is labeled with a ‘clean equipment tag’.
5.1.2.9 Equipment in use should bear the label indicating the stage of process with batch identification details.
5.1.2.10 Switch “OFF” the equipment when not in use.
5.1.2.11 Switch “OFF” the power supply at the end of the day’s work.
5.1.2.12 All equipments are kept labeled and covered at the end of the day’s work.
5.1.2.13 Ensure the steam, air supplies are closed at the end of the day’s work.
5.1.3 Material: Ensure that
5.1.3.1 No dirty/damage containers received from the stores. These are cleaned outside the department, if necessary.
5.1.3.2 All the materials received have Standard raw material tag with all relevant details.
5.1.3.3 Do not keep materials of two products at one pallet to avoid mix-up. Same batch

materials are tied with rope and stored properly.
5.1.3.4 Materials are checked by the Production Chemist by weight/volume and the physical

appearance of each of them should also be checked to ensure that no wrong material has

been received. In case of any doubt, it should be confirmed from stores and / of Q.C. in case

of original intact containers of manufacturers the original label as well as approved label of Q.C. should be checked.
5.1.3.5 The weight / volume of individual raw materials are checked on receipt as well as before adding to the batch.
5.1.3.6 Cleaning and correctness of weighing balances/ measures are checked before use.
5.1.3.7 Material is added to the batch after ensuring that it has reached the stage as indicated in the BMR.

5.1.4 Personal Hygiene: Ensure that
5.1.4.1 Hands are washed before and after every interval.
5.1.4.2 Hair is properly covered by the Hood/cap.
5.1.4.3 No loose material is kept in the pocket of the coat otherwise it might fall in the Product.
5.1.4.4 Overgown/Dangri are changed at every product change over or wherever soiled.
5.1.4.5 No product/ materials from the floor is picked up and added to the batch.
5.1.4.6 No raw material/product is touched with bare hands. Surgical gloves are used while handling material/product.
5.1.5 Records: Ensure that
5.1.5.1 Process instruction for manufacturing are strictly complied with. No deviation is made without permission /approval of the concerned authorities and in case any deviation is made, it should be recorded in the BMR.
5.1.5.2 Entries in the BMR are made simultaneously on the starting and completing of each step and are signed by the Manufacturing Chemist.
5.1.5.3 Raw material tags are put in the BMR after addition of each raw material.
5.1.5.4 The weight/volume of the In-process materials at different stages of manufacture and the final product is recorded after careful weighing measuring.

5.1.6 Granulation: Ensure that
5.1.6.1 Area is cleaned and disinfected as per the standard Operating Procedure. No unwanted material is lying in the room.
5.1.6.2 The AHU, light are all working properly.
5.1.6.3 The Mass Mixer, FBD, Paste Kettle, Sifter, Multi Mill, Blender equipments are perfectly clean.
5.1.6.4 Compressed Air valve are working perfectly, should not be observed any leakage.
5.1.6.5 Materials taken from day store are properly labeled.
5.1.6.6 The doors are kept closed while the machine is in operation.
5.1.6.7 Approved rinse water analysis report has been obtained.
5.1.7 Compression: Ensure that
5.1.7.1 Area is clean and disinfected as per the Standard Operating Procedure.
5.1.7.2 AHU and dehumidifier are working and area is properly maintained.
5.1.7.3 No unwanted material is lying in the room from the previous batch.
5.1.7.4 Compression machine is clean and approved rinse water analysis report has been obtained.
5.1.7.5 The granules taken for compression have been approved by Q.C.
5.1.8 Coating: Ensure that :
5.1.8.1 Area is cleaned and disinfected as per the Standard Operating Procedure.
5.1.8.2 No unwanted material is lying around the Coating Machine.
5.1.8.3 The Machine is clean.
5.1.8.4 AHU is working perfectly.
5.1.8.5 Machine setting is perfect.
5.1.8.6 Steam, air valve are working perfectly.
5.1.8.7 Approved rinse water analysis report has been obtained.
5.1.9 Primary Packing: Ensure that
5.1.9.1 The machine and surrounding area is clean.
5.1.9.2 The inspection zone is properly illuminated.
5.1.9.3 The worker inspecting the tablets is changed after every 2 hours.
5.1.9.4 Rejected tablets are put in the trays.
5.1.9.5 Blister/Strip machine are cleaned as per their respective SOP’s.
5.1.9.6 Area is controlled through AHU.
5.1.9.7 Line clearance taken.
5.1.9.8 All the foil, PVC and tablets are near the machine.
5.1.9.9 Operator, supervisors are wearing mask, gloves inside the machine room.
5.1.9.10 No previous batch material, stereo in the machine room.
5.1.9.11 Approved rinse water analysis report has been obtained.
5.1.10 Packaging: Ensure that
5.1.10.1 The area is clean.
5.1.10.2 No packing material, semi-finished and finished goods of the last batch run is lying
around or below the belt and line clearance taken and signed by the Production
Supervisor and the QA Supervisor after thorough inspection of the belt and
surrounding area.
5.1.10.3 Right materials (of the product and batch) required for packing have

been neatly stacked or kept in containers near the belt.
5.1.10.4 Packing components are checked with the specimen pack kept in

department and with packaging specifications.
5.1.10.5 Cartons, strips and labels etc. are not allowed to fall on the floor.

In rare case, when it happens, the material

is immediately picked up from the floor and kept properly.
5.1.10.6 All packaging operations are carried out in accordance with the packaging specification.
5.1.10.7 Dust bins are used to throw the wrappings of packaging materials and nothing is thrown on the floor.
5.1.10.8 Packed boxes are kept in an orderly way on pallets.
5.1.10.9 All finished goods packed during the day are transferred to finished goods stores at the earliest.
6.0 References
In-house

7.0 Attachments
Nil

8.0 Distribution
Distribution of the controlled copy of the SOP shall be made the concerned
departments.
Additional copies may be issued for specific purpose.

9.0 Abbreviation
SOP : Standard Operating Procedure
QA : Quality Assurance
QC : Quality Control
BMR : Batch Manufacturing Record
FBD : Fluid Bed Dryer
AHU : Air Handling Unit
PVC : Polyvinyl chloride
SS : Stainless steel

10.0 Revision History