within the facility. The scope includes review of batch documentation, analytical results, deviations, and release approval process.

3. Responsibilities

• Production Department: Completes batch manufacturing, fills BMRs/BPRs, and submits them to QA.
• QC Department: Performs analysis, records results, and issues Certificate of Analysis (CoA).
• QA Officer/Executive: Performs line-by-line review of BMR, CoA, and related documentation.
• QA Manager: Authorizes batch release after thorough QA review and signs the Batch Release Authorization Form.

4. Accountability

The Head of Quality Assurance is accountable for ensuring that no batch is released without fulfilling all required checks, validations, and regulatory requirements.

5. Procedure

5.1 Batch Review Initiation

1. Upon completion of batch manufacturing and QC testing, production shall submit the Batch Manufacturing Record (BMR) to QA along with:
   • Analytical raw data
   • Certificate of Analysis (CoA)
   • Deviation/incident reports (if any)
   • Cleaning records and logbooks
   • In-process control data

5.2 Documentation Review by QA

1. QA shall review the entire BMR and attachments using the Batch Release Review Checklist (Annexure-1), verifying:
   • All steps completed as per the approved BMR
   • Signatures, dates, calculations, and observations
   • Equipment cleaning, status labels, line clearance
   • Critical process parameters (CPPs) and yields
2. Review all deviations and confirm appropriate CAPA was implemented.
3. Verify batch number, labeling, packaging records, and reconciliation sheets.

5.3 Review of Analytical Results

1. Check that all required tests are performed as per the approved specification.
2. Ensure all results are within limits and properly documented in the QC report.
3. Confirm system suitability, standard calibration, and raw chromatographic data is available and traceable.

5.4 Certificate of Analysis Verification

1. Verify CoA includes:
   • Product name and code
   • Batch number
   • Manufacturing and retest/expiry date
   • Test specifications and results
   • Approved by QC with signature and date
2. Compare CoA against analytical test data and ensure alignment.

5.5 Final Authorization and Release

1. QA Manager shall:
   • Review the QA Checklist and CoA
   • Verify if all documentation is complete and GMP-compliant
   • Sign the Batch Release Authorization Form (Annexure-2)
2. Update the Batch Release Register (Annexure-3).
3. Inform Warehouse to update inventory and label the batch as “Released.”

5.6 Conditional Release or Rejection

1. Conditional release is allowed only when minor documentation gaps are justified and a CAPA is in place.
2. Rejected batches must be documented using Batch Rejection Form (Annexure-4), with investigation and disposition plan.

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• BMR: Batch Manufacturing Record
• CPP: Critical Process Parameters
• CAPA: Corrective and Preventive Action
• CoA: Certificate of Analysis

7. Documents

1. Batch Release Review Checklist (Annexure-1)
2. Batch Release Authorization Form (Annexure-2)
3. Batch Release Register (Annexure-3)
4. Batch Rejection Form (Annexure-4)

8. References

• ICH Q7 – Section 11: Batch Production and Control Records
• 21 CFR Part 211.192 – Production Record Review
• EU GMP Part II – Sections 5 and 6

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Release Review Checklist

Parameter	Status	Remarks
BMR Review Completed	Yes	All entries verified
Analytical Data Verified	Yes	Consistent with CoA
Deviation Closure	Yes	Two minor deviations closed

Annexure-2: Batch Release Authorization Form

Product Name	Batch No.	QA Reviewer	Authorized By	Release Date
API-X	API01/2504/003	Sunita Reddy	QA Manager	14/04/2025

Annexure-3: Batch Release Register

Batch No.	Product	Release Date	Status	Remarks
API01/2504/003	API-X	14/04/2025	Released	None

Annexure-4: Batch Rejection Form

Batch No.	Reason	Investigation Ref	Disposition	QA Approval
API02/2504/001	OOS result	OOS/2025/04	Rejected	QA Head

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Version	New SOP	QA Head
14/04/2025	2.0	Updated format and CAPA handling	GMP Alignment	QA Head