SOP for Review of BMR

1.0 OBJECTIVE

To lay down a procedure of batch manufacturing record review.

2.0 SCOPE

This procedure applies to the batch manufacturing records in the manufacturing facility.

3.0 RESPONSIBILITY

3.1 Executive – Quality assurance - Prepare the SOP and follow the SOP accordingly
3.2 Asst. manager – Quality assurance & Regulatory affairs - Provide the support to the implementation of SOP and maintained the records.

4.0 ACCOUNTABILITY

4.1 Technical - Director

5.0 PROCEDURE

Following are the guidelines for checking and the final review of batch manufacturing record.
5.1 Head Production / deputy should ensure the completion of all batch documents before submitting to QA.
5.2 Completed batch document duly signed by production manager along with IPQA data, finished product release report, finished goods transfer note and other related data if any to be sent to QA.
5.3 Authorized person in QA will receive, review the BMR thoroughly & record entries as per SOP. A detailed checklist is to be used for ensuring the completion of all data as per Annexure – I.
5.4 Any discrepancy in process, equipment and yield or parameters which may have an impact on yield / quality / safety of drug product should be critically examined. Photocopies of deviation / OOS reports should be attached along with BMR.
5.5 Emphasis to be given on following during BMR review.
5.5.1 General checks as per the check list but checks are not limited to following:
5.5.1.1 Records are submitted timely to QA after completion of the batch.
5.5.1.2 Error free coding details (Batch No., Mfg Date, Exp date, Mfg License no., MRP etc).
5.5.1.3 Tidy / Neat / Legible.
5.5.1.4 Corrections / Overwriting (if any duly signed and dated).
5.5.1.5 Timely entries.
5.5.1.6 Deviation reports if any.
5.5.1.7 Signature
5.5.1.8 Completion.
5.5.1.9 Verification.
5.5.1.10 Material reconciliation
5.5.1.11 For regular/ part batch - Completion
5.5.1.12 IPQA data - Verification
5.5.1.13 Destruction record - Verification
5.5.1.14 Labels reconciliation - Verification
5.5.1.15 Overprinting matter - Verification
5.5.1.16 Yield at all stages - Verification
5.6 Manager - QA & Regulatory affairs shall ensure.
5.6.1 Completion of all documents.
5.6.2 Compliance of all corrections.
5.6.3 Compliance of all deviations.
5.6.4 Yield analysis.

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure

6.2 QA - Quality Assurance
6.3 QC - Quality Control
6.4 NA - Not Applicable
6.5 IPQA - In-process Quality Assurance
6.6 MRP - Maximum Retail Price
6.6 B No. - Batch No.
6.7 No. - Number
6.8 B. Size - Batch size
6.9 Mfg - Manufacturing
6.10 Exp - Expiry
6.11 BMR - Batch manufacturing record

ANNEXURE – I

BMR REVIEW CHECK LIST FOR INJECTABLE

Product :		B.No. :			B.Size:
Date of Mfg.		Date of Exp.
S. No	Particular		OK	Not OK		Remarks
1.0	Product  Name
2.0	Batch No.
3.0	Batch size
4.0	Date of manufacturing
5.0	Date of expiry
6.0	Ingredients
6.1	Standard Quantity
6.2	Input Quantity
7.0	Environmental parameters
7.1	Temperature ( During  manufacturing & packing)
7.2	Relative Humidity (During  manufacturing & packing)
8.0	Filling  – Parameters
9.0	Number of filled vial or Ampoule
10.0	Weight of inspected Vial or Ampoule
11.0	Bill of materials
12.0	Over printing of blisters / carton
13.0	Specimen blister / foil / carton
14.0	Line clearance
15.0	Shipping  marks
16.0	Reconciliation
17.0	Yield analysis
17.1	Yield at mfg. stage
17.2	Yield at packing stage
17.3	Overall yield
17.4	Total loss
17.5	Recovery

Reviewed by ___________                         Approved by ____________
Sign & Date                                                 Sign & Date
(Executive - Quality Assurance)                   (Head - Quality Assurance)

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