Standard Operating Procedure for Final Batch Release Authorization
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/215/2025 |
| Supersedes | SOP/TAB/215/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
The purpose of this SOP is to define the process for the final release of tablet batches, ensuring that all batches meet the required quality standards and comply with regulatory guidelines before they are authorized for distribution and sale.
2. Scope
This SOP applies to all tablet batches produced by the company. It includes processes from the completion of batch production, testing, documentation review, to final release authorization.
3. Responsibilities
- Quality Assurance (QA) Manager: Responsible for overseeing the batch release process, reviewing all records, and ensuring compliance with GMP and regulatory standards.
- Quality Control (QC) Team: Responsible for conducting all required testing (e.g., potency, dissolution, etc.) and documenting the results for batch release approval.
- Production Team: Responsible for maintaining detailed batch records, documenting the production process, and ensuring all activities are compliant with SOPs.
- Regulatory Affairs Team: Ensures that the batch release process complies with regulatory guidelines (FDA, EMA, etc.) and monitors the overall regulatory compliance.
4. Accountability
The QA Manager is accountable for ensuring the final batch release process is adhered to and for reviewing all records and compliance requirements before batch release authorization.
5. Procedure
5.1 Review of Batch Records
- Upon completion of the batch, the production team submits the batch records, including manufacturing logs, production data, and any in-process control logs, to the QA department.
- QA reviews the batch records to ensure completeness and that all required information is documented.
- Ensure all deviations and non-conformances (if any) are documented and reviewed (Annexure-1).
5.2 QC Testing and Results
- The QC team performs required tests, including:
- Identification and strength
- Dissolution and disintegration tests
- Microbial testing (if applicable)
- Stability tests (if applicable)
- Upon completion of testing, QC documents the results, comparing them with pre-established specifications (Annexure-2).
- If the batch meets all criteria, the QC team approves it for release. If any criteria are not met, the batch will be placed on hold for review.
5.3 Batch Release Authorization
- After verifying batch records and test results, the QA Manager reviews and approves the batch release documentation.
- Once the QA Manager confirms that all criteria are met, they authorize the batch release by signing the Batch Release Form (Annexure-3).
- If there are any unresolved issues or deviations, the batch will not be released until corrective actions are implemented and documented.
5.4 Documentation and Record Keeping
- Ensure all records, including batch records, test results, and the Batch Release Form, are documented and securely stored (Annexure-4).
- All batch release documentation should be maintained for a minimum of 5 years or as required by applicable regulations.
- Ensure that all records are accessible for audits and regulatory inspections.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- GMP: Good Manufacturing Practice
7. Documents
- Batch Records (Annexure-1)
- QC Test Results (Annexure-2)
- Batch Release Form (Annexure-3)
- Batch Release Documentation (Annexure-4)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ISO 9001 – Quality Management Systems
- GMP Guidelines for Pharmaceutical Manufacturing
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 Records
| Batch Number | Production Date | Finished Product | Deviations |
|---|---|---|---|
| Batch123 | 01/03/2026 | Tablet ABC, 100mg | None |
Annexure-2: QC Test Results
| Test | Specification | Result | Pass/Fail |
|---|---|---|---|
| Potency | 95-105% of label claim | 98% | Pass |
Annexure-3: Batch Release Form
| Batch Number | Release Date | Authorized By |
|---|---|---|
| Batch123 | 06/03/2026 | QA Manager |
Annexure-4: Batch Release Documentation
| Document | Location | Retention Period |
|---|---|---|
| Batch Release Form | Document Archive | 5 years |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP creation | New procedure | QA Head |
| 01/02/2025 | 2.0 | Updated with new regulatory compliance | Annual review | QA Head |