Standard Operating Procedure for Vendor Qualification for Raw Materials in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/249/2025 |
| Supersedes | SOP/ELX/249/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To establish a formal procedure for evaluating, qualifying, monitoring, and approving vendors supplying raw materials (APIs, excipients, solvents, etc.) used in elixir manufacturing to ensure consistent material quality and regulatory compliance.
2. Scope
This SOP applies to the qualification of all vendors supplying raw materials for use in the Elixir Department, including initial qualification, requalification, and disqualification processes.
3. Responsibilities
- Purchase Department:
- Initiate vendor selection and send qualification questionnaire.
- Quality Assurance (QA):
- Coordinate vendor audits, maintain vendor files, and approve qualification status.
- Quality Control (QC):
- Evaluate material quality and provide analytical feedback.
4. Accountability
The Head of QA is accountable for ensuring that vendors are qualified and monitored in accordance with this SOP and regulatory standards.
5. Procedure
5.1 Vendor Selection
- Purchase department identifies potential vendor based on:
- GMP compliance
- Geographical reliability
- Business
reputation
Send Vendor Qualification Questionnaire (Annexure-1).
5.2 Vendor Evaluation
- QA reviews questionnaire for:
- Manufacturing site licenses
- Quality systems in place
- CoAs and test methods used
- Regulatory approvals (e.g., WHO, FDA, etc.)
- Evaluate at least 3 commercial lots of material before provisional approval.
5.3 Vendor Audit
- QA shall schedule and conduct on-site audits for high-risk or critical vendors (APIs, solvents).
- Audit checklist (Annexure-2) must cover:
- Facility and equipment hygiene
- Documentation and data integrity
- Process controls
- Audit report with CAPA (if any) to be submitted within 10 working days of audit.
5.4 Approval and Listing
- QA reviews audit and analytical evaluation outcomes.
- If satisfactory, add vendor to Approved Vendor List (Annexure-3).
- Assign vendor status: Approved, Conditionally Approved, or Rejected.
5.5 Requalification and Monitoring
- Conduct requalification every 2 years or after any major quality issue.
- Monitor vendor performance using:
- Rejection trends
- OOS/OOT results
- Customer complaints (if applicable)
5.6 Disqualification
- QA may disqualify a vendor based on:
- Repeated quality failures
- Unresolved audit observations
- Breach of GMP compliance
- Document disqualification reason and notify the purchase department.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- CoA: Certificate of Analysis
- OOS: Out of Specification
- CAPA: Corrective and Preventive Action
7. Documents
- Vendor Qualification Questionnaire (Annexure-1)
- Vendor Audit Checklist (Annexure-2)
- Approved Vendor List (Annexure-3)
8. References
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- WHO TRS 1010 – GMP for Pharmaceutical Products
- 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Vendor Qualification Questionnaire
| Vendor Name | Site Address | License No. | GMP Compliance | Primary Contact |
|---|---|---|---|---|
| Shakti Excipients Ltd. | Navi Mumbai, Maharashtra | MH/FDA/2023/236 | WHO-GMP | Mr. Rajesh Kumar |
Annexure-2: Vendor Audit Checklist
| Audit Area | Compliant (Yes/No) | Observations |
|---|---|---|
| Facility Hygiene | Yes | Meets expectations |
| Documentation Control | No | SOPs not version-controlled |
Annexure-3: Approved Vendor List
| Vendor Name | Material Supplied | Approval Date | Status |
|---|---|---|---|
| Shakti Excipients Ltd. | Sorbitol Solution | 01/04/2025 | Approved |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added disqualification process and updated annexures | Process Enhancement | QA Head |