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SOP for Inprocess Monitoring and Control

PURPOSE
To insure that in process parameter are in control and set parameter are being followed consistently.

SCOPE
This procedure is applicable to all dosage form at XYZ Limited.

RESPONSIBILITY
IPQA Chemist

ACCOUNTABILITY
Head Quality Assurance

PROCEDURE

Check the cleanliness of the area / section.
Check the clothing of workmen.
Check the machine log & status label.
Check that all the equipment, vessel is cleaned before use and bear status tag.
Check the RH and temperature are within required limit and being recorded by production persons.
Check that all the containers/bags bear the material/Product identification Label.
Check that the raw material received at shop floor bear material/Product identification label, verify the quantity as per related BPR 
Calibrate IPQA Instrument as per stated frequency.
Operate the IPQA instrument as per SOP.
Check the manufacturing activity is being recorded in BPR online.
Check Weight variation, tablet hardness, diameter, filled volume, filled powder weight etc. as per stated frequency in BPR.
Check that all the container/Bags of intermediate bulk, semi-finished product bear product, process stage status tag and quantified (Refer BPR).
Check The in-process parameter i.e. uniformity of weight, Disintegration time, Friability test, volume as per acceptance criteria given in annexure I.
Check the printed and unprinted packing material as per packing order and verify the quantity (Refer BPR).
Check the coding details w.r.t. batch no., Mfg Date, Exp Date, (ref. BPR) and MRP.
Check the coding details on strip, blister, Label, unit carton, multi-carton, sachets etc. is proper, clearly legible, smudgy, overlap coding is not allowed.
Check leak test for bottle/Strip/blister/Sachet and record.
Check that the strip and blister, bottle, jars, sachets and leaflet or any other literature being placed properly in unit carton/multi-carton/shipper (ref. BPR packing instruction).
Check and collect control sample from the running belt intermittently.
Check that the unit carton/multi-carton/bottle/jars being placed properly in serially no. and labeled shipper (Ref. BPR Packing Operation).
Check that the finally packed shipper is being placed properly in serially no. and labeled shipper. (Ref. BPR Packing Instruction).
Check that the finally packed shippers are being placed on plastic pallets.
If any discrepancies observed in view of above, inform to the production chemist /production Incharge in writing on deviation and corrective action from and inform head QA.


ANNEXURES
Annexure I -- ACCEPTANCE CRITERIA FOR UNIFORMITY OF WEIGHT (MASSES) AND FILLED VOLUME

ABBREVIATIONS
SOP  :  Standard Operating Procedure
QA  :  Quality Assurance
IPQA  :  In process Quality Assurance
BPR  :  Batch Processing Record

REVISION HISTORY
Nil

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