and distribution.

4. Accountability

The Production Manager is accountable for ensuring that all batches are ready for release, with complete and accurate batch records. The QC Manager is responsible for verifying that the batch meets all specifications, while the QA Manager is responsible for approving the batch release.

5. Procedure

5.1 Pre-Release Verification

1. Ensure that all production activities are completed, including mixing, processing, and any in-process quality control checks. Verify that the Batch Manufacturing Record (BMR) is fully completed and signed off by the production team.
2. Ensure that all in-process and final product testing has been performed, and that the results comply with the specifications outlined in the product’s master formula and BMR.
3. Ensure that all raw materials used during production have been properly accounted for and documented in the Raw Material Usage Log (Annexure-1).
4. Confirm that all necessary cleaning and maintenance activities have been performed, as per the relevant SOPs, and that equipment is ready for the next batch.

5.2 QC Review

1. The QC team reviews the following documentation:
   • Batch Manufacturing Record (BMR)
   • Ingredient and material usage logs
   • In-process testing records (e.g., pH, viscosity, microbial testing)
   • Final product testing results (e.g., active ingredient content, appearance, stability)
2. QC verifies that all required testing has been completed, results are within specification, and that no deviations from the approved formula or process occurred during production.
3. If any discrepancies or deviations are found, the batch is placed on hold, and the QC team investigates the cause. The batch is released only after corrective actions have been taken and the product meets all specifications.

5.3 QA Approval

1. The QA team reviews the batch records, including the QC review, to ensure that all required steps have been completed and that the product meets regulatory requirements.
2. QA verifies that all records are accurate and complete, including any necessary deviation reports, corrective actions, and approvals from relevant departments.
3. Once the QA team is satisfied with the documentation and testing results, the batch is approved for release. QA signs the Batch Release Approval form (Annexure-2).
4. If the batch fails to meet specifications or if there are unresolved discrepancies, the batch is rejected, and the QA team documents the reason for rejection in the Deviation Report (Annexure-3).

5.4 Release of Batch

1. Once QA approval is obtained, the batch is released for packaging, labeling, or further processing.
2. The Warehouse Team ensures that the released batch is properly stored in the designated area and is ready for the next stage in the production process.
3. The batch number, release date, and any relevant details are recorded in the Batch Release Log (Annexure-4) for tracking and traceability purposes.

5.5 Documentation and Record-Keeping

1. Ensure that all batch release documentation, including the BMR, QC testing records, QA approval forms, and release logs, are stored and maintained for at least two years or as per regulatory requirements.
2. Ensure that all batch release documentation is readily available for audit or inspection by regulatory agencies.
3. Store all records in a secure and organized manner, following GMP guidelines for record-keeping and documentation control.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• PPE: Personal Protective Equipment

7. Documents

1. Annexure-1: Raw Material Usage Log
2. Annexure-2: Batch Release Approval Form
3. Annexure-3: Deviation Report
4. Annexure-4: Batch Release Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Batch Release Process

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Raw Material Usage Log

Material Name	Quantity Used	Batch Number	Operator	Time
Raw Material A	100 kg	12345	John Doe	09:00 AM

Annexure-2: Batch Release Approval Form

Batch Number	Approval Date	Approved By	Remarks
12345	21/01/2026	QA Head	Batch approved for release

Annexure-3: Deviation Report

Batch Number	Deviation Description	Corrective Action	Resolved By
12345	Material variance in raw material usage	Revised BMR, recalculated ingredients	QA Head

Annexure-4: Batch Release Log

Batch Number	Release Date	Released By	Remarks
12345	21/01/2026	Production Supervisor	Ready for packaging

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head