Standard Operating Procedure for Product Release Authorization in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/248/2025 |
| Supersedes | SOP/ELX/248/2022 |
| Page No. | Page 1 of 7 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define the procedure for authorizing the release of finished elixir products after completion of manufacturing, testing, and batch documentation review, in accordance with cGMP and regulatory requirements.
2. Scope
This SOP applies to all commercial and validation batches of elixirs manufactured and tested within the facility and intended for release to the market or further processing.
3. Responsibilities
- Production Officer:
- Ensure batch manufacturing record (BMR) is completed and submitted to QA.
- QC Analyst:
- Complete all required analytical testing and submit results to QA.
- QA Reviewer:
- Review batch records, QC data, and ensure compliance before batch release.
4. Accountability
The Head of Quality Assurance is accountable for final authorization and release of the product batch. The Head of Production is responsible for compliance with manufacturing and documentation practices.
5. Procedure
5.1 Batch Documentation
Review
- QA shall receive the complete BMR and associated records from production.
- Verify the following:
- Batch number, product name, strength, pack size
- Line clearance entries
- Manufacturing process steps, signatures, and timestamps
- Yield reconciliation and deviations (if any)
5.2 Review of QC Analytical Results
- Confirm all raw materials, in-process samples, and finished product results meet specifications.
- Review chromatograms, microbial test reports, alcohol content, viscosity, clarity, and pH results.
- Ensure OOS or OOT results are resolved and approved by QA prior to release.
5.3 Final Release Decision
- After complete review, QA shall fill the Product Release Authorization Form (Annexure-1).
- Product can only be released after QA Head’s signature and date of authorization.
- Released batches shall be recorded in the Batch Release Register (Annexure-2).
5.4 Retention and Traceability
- All batch-related documents must be archived securely and be traceable for audits.
- Electronic or manual logs must be updated upon release.
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- QC: Quality Control
- OOS: Out of Specification
- OOT: Out of Trend
7. Documents
- Product Release Authorization Form (Annexure-1)
- Batch Release Register (Annexure-2)
- Analytical Test Reports
8. References
- 21 CFR Part 211.165 – Testing and Release for Distribution
- ICH Q10 – Pharmaceutical Quality System
- WHO GMP Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Product Release Authorization Form
| Batch No. | Product Name | Pack Size | Manufacturing Date | Expiry Date | Released By | Remarks |
|---|---|---|---|---|---|---|
| ELX-0425-059 | Iron Elixir | 100 mL | 01/04/2025 | 03/2027 | Sunita Reddy | Approved for distribution |
Annexure-2: Batch Release Register
| Date | Batch No. | Product | Released By | Remarks |
|---|---|---|---|---|
| 11/04/2025 | ELX-0425-059 | Iron Elixir | Sunita Reddy | QA Release Approved |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP Creation | QA Head |
| 11/04/2025 | 2.0 | Clarified QA approval workflow and added Annexures | GMP Alignment | QA Head |