Standard Operating Procedure for Vendor Qualification and Approval in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/001/2025 |
| Supersedes | SOP/API/001/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a comprehensive, risk-based process for evaluating, qualifying, approving, and monitoring vendors supplying raw materials, excipients, solvents, packaging components, and critical utilities used in Active Pharmaceutical Ingredient (API) manufacturing. This SOP ensures that materials procured meet predefined quality and regulatory standards and originate from GMP-compliant sources.
2. Scope
This SOP applies to all vendors supplying materials and services to the API manufacturing facility. It includes manufacturers, traders, repackers, contract laboratories, transportation providers, and packaging vendors. The SOP is applicable from initial vendor identification through qualification, approval, and ongoing re-evaluation.
3. Responsibilities
- Purchase Department:
- Initiate vendor evaluation requests.
- Coordinate collection of vendor documentation and technical agreements.
- Communicate requirements to vendors.
- Quality Assurance (QA):
- Conduct risk assessments, site audits, and documentation reviews.
- Maintain the Approved Vendor List (AVL).
- Coordinate requalification activities and complaint investigations.
- Quality Control (QC):
- Test trial samples for conformance to specifications.
- Share analytical feedback with QA.
- Regulatory Affairs (RA):
- Verify regulatory compliance (e.g., DMF availability, import/export licenses).
4. Accountability
The Head of Quality Assurance is accountable for ensuring that vendor qualification procedures are strictly followed and that only qualified and approved vendors are used for procurement of GMP-relevant materials.
5. Procedure
5.1 Vendor Identification and Initial Assessment
- Vendor identification may be initiated by the Purchase, QA, or RA department.
- A formal Vendor Evaluation Request Form (VERF) must be submitted by the Purchase Department to QA.
- The vendor must submit the following documents:
- Company Profile
- Manufacturing License/Drug License
- Valid GMP Certificate
- Quality Manual and/or Site Master File
- Recent Audit Reports (if available)
- List of customers, including regulatory inspections (e.g., USFDA, EDQM, CDSCO)
5.2 Risk Assessment and Categorization
- QA shall perform a documented risk assessment based on:
- Criticality of the material
- Regulatory requirements
- Supplier history and geographical location
- Previous audit outcomes
- Vendors are categorized into:
- Low Risk: Approved and frequently audited sources
- Medium Risk: Known suppliers without recent audits
- High Risk: New vendors or vendors for high-impact materials (e.g., solvents, key intermediates)
5.3 Vendor Site Audit
- For Medium and High-Risk vendors, an on-site audit is mandatory before approval.
- Audits shall be conducted by qualified auditors using the approved Vendor Audit Checklist.
- Key focus areas include:
- GMP compliance
- Sanitation and hygiene
- Analytical capabilities
- Document control and record keeping
- Training and qualification of personnel
- An audit report must be prepared and reviewed within 15 working days.
5.4 Sample Evaluation
- Upon satisfactory documentation and audit outcome, a minimum of three representative trial samples shall be requested from the vendor.
- QC will conduct full analysis as per the approved specification.
- The results shall be compared with the vendor’s Certificate of Analysis (CoA).
- Discrepancies, if any, must be documented and investigated.
5.5 Approval and Inclusion in AVL
- If all evaluations are satisfactory, QA shall issue a Vendor Approval Certificate.
- The vendor shall be entered into the Approved Vendor List (AVL) with:
- Vendor Name and Address
- Type of material
- Approval Date
- Category (Raw Material / Solvent / Packaging)
- A copy of the approval certificate and relevant records must be maintained in the Vendor Qualification Dossier.
5.6 Requalification and Performance Monitoring
- All vendors shall be reviewed biennially or earlier in the event of:
- Material quality complaints
- Regulatory audit observations
- Change in location or manufacturing process
- Performance shall be monitored based on:
- Delivery timelines
- CoA and batch consistency
- Audit scores and responses
- Non-performing vendors shall be disqualified and removed from the AVL.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- CoA: Certificate of Analysis
- DMF: Drug Master File
- AVL: Approved Vendor List
- VERF: Vendor Evaluation Request Form
7. Documents
- Vendor Qualification Checklist (Annexure-1)
- Vendor Audit Report (Annexure-2)
- Vendor Approval Certificate (Annexure-3)
8. References
- ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- WHO TRS 986 Annex 2
- 21 CFR Part 211 (US FDA)
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | Rajesh Kumar | Sunita Reddy | Manoj Verma |
| Designation | QA Officer | QA Manager | Head QA |
| Department | API Manufacturing | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Vendor Qualification Checklist
| Item | Status | Remarks |
|---|---|---|
| GMP Certificate | Available | Valid Until 31/12/2026 |
| Audit Conducted | Yes | Audit Score 87% |
| Sample Evaluation | Pass | Meets Specifications |
Annexure-2: Vendor Audit Report
| Audit Date | Vendor Name | Location | Findings | Corrective Actions |
|---|---|---|---|---|
| 01/04/2025 | FineChem Labs | Ahmedabad | Minor gaps in logbook control | Closed with CAPA |
Annexure-3: Vendor Approval Certificate
| Vendor Name | Material Type | Approval Date | Approved By |
|---|---|---|---|
| FineChem Labs | API Intermediate | 12/04/2025 | Manoj Verma |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial version | New SOP Release | QA Head |
| 13/04/2025 | 2.0 | Expanded to include risk-based audit | Annual Review | QA Head |