Standard Operating Procedure for Review of Batch Records

1.0 Purpose :

To provide guidelines for review of Batch Manufacturing Record (BMR) and Batch Packaging record (BPR).

2.0 Scope :

This procedure is applicable for the review of BMR & BPR of all the products manufactured at [Company name].

3.0 Responsibility :

QA Personnel: To perform the activity.

Head – QA: Monitoring the effective implementation

4.0 Definition:

Not Applicable

5.0 Procedure :

5.1 BMR (Batch Manufacturing Record)

5.1.1 Manufacturing personnel shall complete the Batch Manufacturing Record and BMR shall be reviewed as per checklist and sign it with date. After completion of review, batch records shall submit to QA personnel for review the same.

5.1.2 QA personnel shall review the BMR and attached records along with the analytical data from QC as per the checklist.

5.1.3 After completion of review, if any discrepancies are observed, the record shall be returned to respective department.

5.1.4 After compliance of discrepancies, the batch record file shall be submitted to QA personnel.

5.1.5 QA personnel shall review the BMR and than sign the same with date.

51.6 After approval of COA of the batch at semi-finished stage, QA Personnel shall attach copy of “certificate of analysis” and put sign and date on checklist of BMR. Thenafter, the batch shall be released only for packaging.

5.2 BPR (Batch Packing Record).

5.2.1 Packaging personnel shall complete the Batch Packing Record and BPR shall be reviewed as per checklist and then sign the same on Batch Packing Record with date.

5.2.2 After completion of review, batch records shall submit to QA personnel for review the same.

5.2.3 QA person shall review the BPR as per the checklist.

5.2.4 After completion of review of BPR, if any discrepancies are observed, the file of BMR & BPR shall be returned to Packaging department.

5.2.5 After compliance of discrepancies, the batch record file shall be submitted to QA personnel.

5.2.6 QA personnel shall review the BPR and than sign on Batch Packing Record with date, checklist of BPR.

5.2.7 After approval of COA of the batch. QA personnel shall attach copy of “certificate of analysis” and put sign and date on checklist of BPR and cover page of Batch Record file. Manager QA shall enter quantity released for the batch with signature and date in the reviewed Batch Packing Record and prepare batch release certificate and attach it to batch record.

5.2.8 Manager QA shall sign on the covering page of Batch Record file with date and release the batch for distribution as per respactive SOP .

5.2.9 Batch Record file shall be stored in document cell as per the respactive procedure for storage and control of Quality Assurance Document.

6.0 Frequency:

As and when batch is manufactured and packed

7.0 Formats:

7.1 Checklist for review of Batch record

Batch Manufacturing Record (BMR)

Sr.  No.	Checklist	Ok/Not Ok
1	Check for the ‘Cleaned’, ‘In-process Quarantine’ labels and printouts of equipment in the batch records.
2	Check for the batch number, manufacturing and expiry date and their accordance with the batch details.
3	Check for completed Formulation Order with control no. and quantity issued duly filled in.
4	Check for Material tickets of all the ingredients with signatures.
5	Check for Additional Material Requisition or Credit Material Return slips, if any.
6	Check for duly filled BMR, with signatures of operators and supervisors for each activity.
7	Check for adherence to the timing, equipment and accessories specifications and process parameters as mentioned in the respective BMR.
8	Check for yield analysis after each stage as per the respective BMR.
9	Check for over writings or calculation errors, if any.
10	Check for the final yield reconciliation after completion of blending, compression, coating or capsule filling of a batch.
11	Check for the in-process parameters observed with respect to the standards as per the respective BMR.
12	Check for any additional page issuance reconciliation.
13	Check if any deviations, change control, observed for this particular batch.

Sr. No.	Granules /Pellets/ Blend	Granules /Pellets/ Blend	Core Tablets / Capsule	Coated / Imprinted Tablets
1	Check for the Test request form and Technical Information sheets for each stage as per the respective BMR.
2	Check if any Out of specification results were observed during analysis.
	Reviewed By (Sign/Date)

 Batch Packaging Record (BPR)

Sr. No.	Checklist	*Ok/ Not Ok
1	Check for the ‘Cleaned’, ‘In-process Quarantine’ labels and printouts of equipment in the batch records.
2	Check for the batch number, manufacturing and expiry date and their accordance with the batch details.
3	Check for duly filled Packaging Order with control no., quantity issued and signature with date.
4	Check for Material tickets of all the materials with signatures.
5	Check for Additional Material Requisition or Credit Material Return slips, if any.
6	Check for duly filled BPR, with signatures of operators and supervisors for each activity.
7	Check for adherence to the timing, equipment and accessories specifications and process parameters as mentioned in the respective BPR.
8	Check for over writings or calculation errors, if any.
9	Check for the in-process parameters observed with respect to the standards as per the respective BPR.
10	Check for approved specimens of overprinted cartons / catch covers, foils, leaflets, labels and shipper label.
11	Check for the reconciliation of printed packaging materials and the variance.
12	Check for the final yield reconciliation after completion of the packaging of the batch.
13	Check for any additional page issuance reconciliation.
14	Check if any deviations, change control, observed for this particular batch.
	Reviewed By (Sign/Date):

 Other Check points

Sr. No.	Checkpoint	Remark/ Observation
1	Check the Test request form, Analytical record and Certificate of Analysis of the finished products and the conformance of the product to the respective standards.
2	Check if any OOS results were observed OOS No.:
3	Check if any Incident were observed Incident No.:
4	Check if any Deviation were observed Deviation No.:
5	Check if any Temparary Change Control were observed, Reference No.:
	Reviewed By (Sign/Date):