API Manufacturing: SOP for Vendor Qualification and Approval Process – V 2.0

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