batch records during and after manufacturing operations of injectable products within the sterile manufacturing unit.

3. Responsibilities

• Production Operators: Record all manufacturing operations immediately after performance.
• Production Supervisors: Review entries for accuracy and ensure all entries are complete.
• Quality Assurance Officers: Review and approve records as part of batch release activities.

4. Accountability

The Manufacturing Head is accountable for adherence to the SOP and data integrity. QA Head is accountable for final approval and compliance oversight.

5. Procedure

5.1 Types of Records

1. Batch Manufacturing Records (BMR)
2. Batch Packaging Records (BPR)
3. In-process Control Records
4. Cleaning Logs
5. Sterilization Records

5.2 General Documentation Guidelines

1. Use only black or blue permanent ink pens.
2. Make entries immediately after the activity is completed.
3. Do not leave any blank fields. Write “N/A” if not applicable.
4. All corrections must be made with a single strike-through, initialed, dated, and justified.
5. Overwriting, use of white ink, or erasing is strictly prohibited.
6. Each page of the batch record must be signed and dated by the person performing and verifying the activity.

5.3 Batch Record Entries

1. Include product name, batch number, batch size, manufacturing and expiry dates, MFR reference, and line used.
2. Document the following:
   • Raw material details and dispensed quantities
   • Equipment used and its ID
   • Start and end times of each process step
   • Environmental conditions
   • In-process test results and acceptance
   • Yield at each stage and reconciliation details
   • Cleaning verification of equipment and area

5.4 Real-Time Recording

1. Operators must record observations concurrently with the activity.
2. Do not pre-fill or post-fill data.
3. Use logbooks for entries such as equipment cleaning or autoclave usage and cross-reference them in the batch record.

5.5 Deviations and Incidents

1. Document any deviation in the respective area and notify QA immediately.
2. Fill Deviation Report (Annexure-1) with brief description, investigation summary, and approval status.

5.6 Final Review

1. Ensure completeness and accuracy of every section.
2. Production supervisor and QA must review entries before release.
3. File the completed batch record in the archival room for a minimum of one year after product expiry.

6. Abbreviations

• SOP: Standard Operating Procedure
• BMR: Batch Manufacturing Record
• BPR: Batch Packaging Record
• QA: Quality Assurance
• MFR: Master Formula Record

7. Documents

1. Deviation Report – Annexure-1
2. Batch Record Review Checklist – Annexure-2
3. Document Correction Log – Annexure-3

8. References

• WHO TRS 986 Annex 2 – GMP Guidelines
• EU GMP Annex 1 and 11
• 21 CFR Part 211 – USFDA cGMP for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Deviation Report

Date	Batch No.	Description	Immediate Action	Approved By
24/06/2025	SB126A	Documentation Error	Corrected per SOP	Sunita Reddy

Annexure-2: Batch Record Review Checklist

Section	Check Performed	Reviewed By	Remarks
Material Weighing	Yes	Ajay Verma	Accurate

Annexure-3: Document Correction Log

Date	Page No.	Error Type	Corrected By	Reviewed By
24/06/2025	Page 8	Incorrect Date	Ravi Sharma	QA Officer

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial Issue	New Format	QA Head
24/06/2025	2.0	Expanded Review Protocol	Annual Review	QA Head