Standard Operating Procedure for Batch Release of Injectable Products
| Department | Sterile Injectable Manufacturing |
|---|---|
| SOP No. | SOP/SIM/082/2025 |
| Supersedes | SOP/SIM/082/2022 |
| Page No. | Page 1 of 14 |
| Issue Date | 18/06/2025 |
| Effective Date | 20/06/2025 |
| Review Date | 18/06/2026 |
1. Purpose
To define the procedure for batch release of sterile injectable products after completion of manufacturing, quality control, and review of necessary documentation, ensuring product quality, safety, and compliance with GMP regulations.
2. Scope
This SOP applies to all batches of sterile injectable products
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
- Receive complete Batch Manufacturing Record (BMR) and batch packing records from production.
- QA performs a checklist-based review (Annexure-1) of BMR, ensuring ALCOA+ compliance.
- QC submits Certificates of Analysis (CoA) with results for all in-process and finished product tests.
- Compare actual yield with theoretical yield; acceptable deviation: ±5%.
- Ensure environmental monitoring, sterilization logs, and cleaning validation records are reviewed.
5.2 Final QA Review and Authorization
- Summarize findings in the Batch Release Authorization Form (Annexure-2).
- Confirm reconciliation of raw materials, packaging materials, and labels.
- Check compliance with all in-process control parameters.
5.3 Product Status Labeling
- Upon approval, affix “Released” status labels on shipper boxes.
- If rejected, move product to designated rejection area with red labels marked “REJECTED”.
5.4 Document Retention
- 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
- Batch Review Checklist – Annexure-1
- Batch Release Authorization Form – Annexure-2
- 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 |