manufactured at the facility that require batch release by the Quality Assurance department.

3. Responsibilities

• QA Officer: Review batch documentation and ensure all test results are within specifications.
• QC Analyst: Provide validated analytical results for each batch.
• Production Supervisor: Ensure BMR and logbooks are completed and submitted to QA.
• Head QA: Final authority for batch release.

4. Accountability

The Head of Quality Assurance is accountable for the release of batches only after full compliance with product and process quality requirements.

5. Procedure

5.1 Batch Review and Approval

1. Receive complete Batch Manufacturing Record (BMR) and batch packing records from production.
2. QA performs a checklist-based review (Annexure-1) of BMR, ensuring ALCOA+ compliance.
3. QC submits Certificates of Analysis (CoA) with results for all in-process and finished product tests.
4. Compare actual yield with theoretical yield; acceptable deviation: ±5%.
5. Ensure environmental monitoring, sterilization logs, and cleaning validation records are reviewed.

5.2 Final QA Review and Authorization

1. Summarize findings in the Batch Release Authorization Form (Annexure-2).
2. Confirm reconciliation of raw materials, packaging materials, and labels.
3. Check compliance with all in-process control parameters.

5.3 Product Status Labeling

1. Upon approval, affix “Released” status labels on shipper boxes.
2. If rejected, move product to designated rejection area with red labels marked “REJECTED”.

5.4 Document Retention

1. Store all batch records, CoAs, deviations, and release documents in the QA archive for a minimum of 5 years.

6. Abbreviations

• SOP: Standard Operating Procedure
• BMR: Batch Manufacturing Record
• CoA: Certificate of Analysis
• QA: Quality Assurance
• QC: Quality Control
• ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available

7. Documents

1. Batch Review Checklist – Annexure-1
2. Batch Release Authorization Form – Annexure-2
3. Certificate of Analysis – Annexure-3

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211 – GMP for Finished Pharmaceuticals
• WHO TRS 986 Annex 2 – GMP for Sterile Products

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: Batch Review Checklist

Checklist Item	Status	Remarks
All BMR pages completed and signed	Yes	Complete
IPC results within limits	Yes	Verified

Annexure-2: Batch Release Authorization Form

Batch No.	INJ-2394
Product Name	Ceftriaxone Injection 1g
Manufacturing Date	01/06/2025
QA Review Date	15/06/2025
Released By	Rajesh Kumar
Remarks	No deviations, meets all specifications

Annexure-3: Certificate of Analysis

Parameter	Specification	Result	Status
Assay	98.0% – 102.0%	99.4%	Complies
pH	4.5 – 6.5	5.2	Complies
Sterility	No Growth	No Growth	Complies

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	QA Head
18/06/2025	2.0	Updated format and included ALCOA+ principles	Regulatory alignment	QA Head