SOP FOR REVIEW OF BATCH PROCESSING RECORD
PURPOSE: To lay down the procedure for reviewing of contents in Batch manufacturing Record.
SCOPE: This SOP is applicable to Batch manufacturing Records at various stages of Manufacturing and Packaging.
RESPONSIBILITY:
Preparation of SOP: Officer/ Sr.Officer
Checking and Review of the SOP: Executive /Sr. Executive
Approval of SOP: Head of Department/Assistance Manager
Authorization of SOP: Head QA/Designee
ACCOUNTABILITY: Head QA/ Designee shall be accountable for compliance of the SOP.
PROCEDURE:
When the batch manufacturing record has been completed and assembled, the concerned department submit it to Q.A. department for review and approval.
A. department will review the key steps of batch manufacturing records, which include:
Check the total number of pages of batch manufacturing record and verify that required supplemental pages (requisition slip and issue slip of raw material and packing material and label) are attached.
Verification of correctness of product details which include Product name, Batch number, Batch size, work order number, manufacturing date and expiry date.
Verify that all the blank spaces are filled, all choices are marked.
Verify that entries are readable.
Verify that if any correction made to the entries on a document shall be signed and dated; the correction should permit the reading of the original information. Do not use
Corrective fluid or erasable pens to correct the original information.
Verification of controlled environment conditions (temperature and humidity).
Line clearance at relevant stages is certified.
Verification of calculations, weighing of materials.
Verification of signatures of authorized person who directly performing and supervising each critical step in the process.
Verification of critical process parameters, specific to each product to ensure that time, temperature, pressure are within specification.
Verification of yield at each step in the process has been accurately calculated and within specification.
Verification of time entries should be consistent with internal standards.
Verify that in-process and finish good testing reports are attached.
Specimen of printed foil / approved overprinted packing materials is attached with the batch record.
Primary / secondary packing details are recorded with signature and date.
The packing yield is recorded and within specification.
Reconciliation of packaging materials is completed.
Certificate of analysis of product attached with record.
If no discrepancy is noted during review of the batch record, the batch record is considered as in compliance and QA approves the batch record.
If any discrepancy is noted, return the batch record to production department for compliance. Production department reviews the discrepancy. Such batch records are given back to QA for review.
QA reviews the batch record for the discrepancy noted and if no discrepancy found during the review, then batch record is considered as in compliance and QA Authorize the batch record.
Trend analysis of discrepancy observed during BMR review is done quarterly for recurring type of discrepancy. Necessary corrective measures are planned to reduce such discrepancies.
REFERENCE:
Standard Operating procedure for Standard operating procedure.
Change control procedure
List of documents
Check the total no of pages of batch processing record.
Check required supplemental pages like requisition, issue slip of raw material and packing material attached.
Correct product name, batch number, batch size, work order no, mfg. and exp. date mentioned on all pages of record.
All the blank spaces are filled, and all choices are marked.
Are all entries readable?
Any correction made is signed and dated.
Environmental conditions are within the limit.
Line clearance at relevant stages is certified.
Materials are weighed as calculated.
Manufacturing process details are recorded with signature and date.
All in-process checks are carried out as per instruction given in MFR.
All in-process findings are within the limit of the specified parameters.
The manufacturing yield at all critical stages are calculated and are within specified limit.
Analytical report for the in-process product is attached, and tests results are within specifications.
Check the total no pages of batch packing record.
Correct product name, batch number, batch size, work order no, mfg. and exp. date mentioned on all pages of record.
Specimen of printed foil / approved overprinted packing materials is attached with the batch record.
Primary / secondary packing details are recorded with signature and date.
All in-process checks are carried out as per instruction given in BPR.
All in-process findings are within the limit of the specified parameters.
The packing yield is recorded and within specification.
Reconciliation of packaging materials is completed.
Analytical report for the finished product is attached, and tests results are within specifications.
Certificate of analysis of product attached with record.
The product complies/ does not comply with laid down specification and cGMP requirements. QA has reviewed the document and batch Released / Not Released for distribution.