Standard Operating Procedure for Vendor Qualification and Audit in Vaginal Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to define the procedure for the qualification and audit of vendors supplying materials or services critical to the manufacturing of vaginal dosage forms.

2) Scope

This SOP applies to the procurement, quality assurance, and quality control departments at [Company Name] responsible for vendor qualification and audit.

3) Responsibilities

Quality Assurance (QA) is responsible for overseeing vendor qualification and audit procedures. Procurement is responsible for initiating and coordinating vendor qualification. Quality Control (QC) supports QA in conducting audits and evaluating vendor performance.

4) Procedure

4.1 Vendor Selection

1. Identify vendors based on procurement requirements and specifications.
2. Assess vendors for capability to meet quality and regulatory requirements.

4.2 Vendor Qualification

1. Request and review vendor documentation (e.g., quality agreements, certificates, audits).
2. Perform on-site audits or assessments if necessary to verify compliance.

4.3 Vendor Audit

1. Plan and schedule vendor audits based on risk assessment and audit schedule.
2. Conduct audits according to predefined checklist and audit plan.
3. Document findings, including non-conformances, and communicate with vendors for corrective actions.

4.4 Vendor Performance Evaluation

1. Regularly evaluate vendor performance based on predefined metrics (e.g., quality, delivery, compliance).
2. Review and update vendor qualification status based on performance evaluations.

4.5 Vendor Change Control

1. Implement change control procedures for vendor changes (e.g., new vendor selection, discontinuation).
2. Update relevant documentation and notify affected departments.

5) Abbreviations, if any

QA: Quality Assurance; QC: Quality Control; SOP: Standard Operating Procedure

6) Documents, if any

Vendor qualification checklist, Audit report template, Vendor performance evaluation form

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, WHO Technical Report Series No. 957, Annex 7: Guidelines on Good Manufacturing Practices for Pharmaceutical Products

8) SOP Version

Version 1.0