SOP for In-process Monitoring and Control

PURPOSE

Ensure that in-process parameters are in control and set parameters are followed consistently.

SCOPE

This procedure is applicable to all dosage forms at PharmaInfo 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 and vessels are cleaned before use and bear status tags.
• Check the RH and temperature are within the 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 the shop floor bears the 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.

ALSO READ: Question and Answer for In-process Parameters for Tablets and Capsules

• Check the manufacturing activity is being recorded in BPR online.
• Check Weight variation, tablet hardness, diameter, filled volume, filled powder weight, etc. as per the stated frequency in BPR.
• Check that all the containers/Bags of intermediate bulk, and semi-finished products bear product, and process stage status tags and are quantified (Refer to BPR).
• Check The in-process parameter i.e. uniformity of weight, Disintegration time, Friability test, and volume as per the acceptance criteria given in Annexure I.
• Check the printed and unprinted packing material as per the packing order and verify the quantity (Refer to 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, and 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, leaflets or any other literature are being placed properly in unit carton/multi-carton/shipper (ref. BPR packing instruction).
• Check and collect control samples from the running belt intermittently.
• Check that the unit carton/multi-carton/bottle/jars are 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 are observed in view of the above, inform the production chemist /production In-charge in writing of deviation and corrective action and inform the 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

ALSO READ: SOP for Reprocessing of Out of Specification Batch