Standard Operating Procedure for SOP Review and Control in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/250/2025 |
| Supersedes | SOP/ELX/250/2022 |
| 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 the creation, review, approval, distribution, revision, retrieval, and archival of Standard Operating Procedures (SOPs) to ensure consistent practices and regulatory compliance across the Elixir Department.
2. Scope
This SOP applies to all SOPs that govern the activities in manufacturing, quality control, quality assurance, engineering, and warehouse operations within the Elixir Department.
3. Responsibilities
- Document Originator:
- Drafts the SOP using approved templates and initiates revisions when required.
- QA Documentation Cell:
- Controls SOP numbering, distribution, archival, and ensures implementation.
- Department Head:
- Reviews and approves department-specific SOPs for accuracy and relevance.
4. Accountability
The Head of Quality Assurance is accountable for the compliance and effectiveness of the SOP review and control process.
5. Procedure
5.1 SOP Preparation
- Use the approved SOP template from QA which includes:
- Title, SOP number, purpose, scope,
responsibilities, procedure, version, revision history
Each SOP must be assigned a unique SOP number (e.g., SOP/ELX/XXX/YYYY).
5.2 SOP Review
- All SOPs must be reviewed at least once every two years or sooner if:
- There are regulatory changes
- There are process changes or equipment upgrades
- Deviation or audit findings require revision
- QA initiates a review by notifying the respective department.
5.3 SOP Approval
- After review, the SOP is signed by:
- Prepared by – Originator
- Checked by – Department Head
- Approved by – QA Head
- Approval signatures must be dated and documented in the approval section.
5.4 SOP Issuance and Distribution
- QA issues controlled copies of the approved SOP to relevant departments.
- A copy control record is maintained (Annexure-1: SOP Distribution Record).
5.5 SOP Revision
- Revisions must be initiated through a change control or scheduled review.
- Revised SOPs must include:
- New version number
- Reason for change in the revision history
- Superseded SOP retrieval
5.6 SOP Archival and Retrieval
- Obsolete SOPs must be stamped “Obsolete” and archived for at least 5 years.
- Retrieval of old SOPs for audits or investigations must be approved by QA.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- cGMP: Current Good Manufacturing Practices
7. Documents
- SOP Distribution Record (Annexure-1)
- SOP Master List (Annexure-2)
- Change Control Request (if applicable)
8. References
- ICH Q10 – Pharmaceutical Quality System
- WHO TRS 986 – Annex 2 GMP Guidelines
- 21 CFR Part 211.100 – Written Procedures
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: SOP Distribution Record
| SOP No. | Version | Issued To (Department) | Copy No. | Issued By | Issue Date |
|---|---|---|---|---|---|
| SOP/ELX/250/2025 | 2.0 | Manufacturing | 01 | Rajesh Kumar | 15/04/2025 |
Annexure-2: SOP Master List
| SOP No. | Title | Effective Date | Version | Status |
|---|---|---|---|---|
| SOP/ELX/250/2025 | SOP Review and Control | 15/04/2025 | 2.0 | Active |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added Annexures and updated review cycle details | Compliance Enhancement | QA Head |