Vendor Audit and Evaluation – Standard Operating Procedure

1) Purpose

To establish guidelines for conducting vendor audits and evaluations to ensure compliance with quality and regulatory requirements.

2) Scope

This SOP applies to all vendor audit and evaluation activities conducted by the pharmaceutical purchase department.

3) Responsibilities

Quality Assurance Team: Responsible for planning and conducting vendor audits.
Purchasing Team: Responsible for coordinating evaluations and maintaining vendor records.

4) Procedure

4.1) Audit Planning:
4.1.1) Identify vendors to be audited based on risk assessment.
4.1.2) Develop audit plans including objectives and scope.

4.2) Conducting Audits:
4.2.1) Schedule audits with vendors and notify them in advance.
4.2.2) Perform on-site audits according to the audit plan.

4.3) Audit Reporting:
4.3.1) Document audit findings, observations, and non-conformances.
4.3.2) Prepare audit reports for review and approval.

4.4) Corrective Actions:
4.4.1) Issue corrective action requests (CARs) for identified non-conformances.
4.4.2) Monitor and verify effectiveness of corrective actions.

4.5) Vendor Performance Evaluation:
4.5.1) Evaluate vendor performance based on audit results and other criteria.
4.5.2) Maintain vendor performance records and update as necessary.

5) Abbreviations, if any

N/A

6) Documents, if any

• Audit Plans
• Audit Reports
• Corrective Action Reports
• Vendor Performance Scorecards

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 820, ICH Q9
Industry Standards: ISO 13485:2016

8) SOP Version

Version 1.0