Standard Operating Procedure for Supplier Qualification and Management

Purpose

The purpose of this SOP is to establish procedures for the qualification, evaluation, and ongoing management of suppliers to ensure the procurement of quality materials and services in compliance with Good Distribution Practice (GDP) guidelines.

Scope

This SOP applies to all personnel involved in the selection, qualification, and management of suppliers for pharmaceutical products and related services.

Responsibilities

• The Procurement Department is responsible for supplier selection, qualification, and contract negotiation.
• The Quality Assurance (QA) Department is responsible for assessing supplier quality and compliance with GDP requirements.
• The Quality Control (QC) Department is responsible for conducting inspections and testing of incoming materials.
• The Regulatory Affairs Department is responsible for ensuring supplier compliance with regulatory requirements.

Procedure

1. Supplier Selection:
   • Identify potential suppliers based on product or service requirements.
   • Evaluate supplier capabilities, quality systems, and regulatory compliance.
2. Supplier Qualification:
   • Conduct supplier audits or assessments to evaluate facilities, processes, and quality management systems.
   • Review supplier documentation, such as quality agreements, certificates, and regulatory approvals.
3. Supplier Approval:
   • Approve suppliers based on satisfactory qualification results and compliance with established criteria.
   • Document supplier approval status and maintain an approved supplier list.
4. Supplier Performance Monitoring:
   • Monitor supplier performance through regular reviews, audits, and evaluations.
   • Address any non-conformities or performance issues with the supplier through corrective actions.
5. Supplier Change Management:
   • Assess the impact of supplier changes on product quality, regulatory compliance, and supply chain continuity.
   • Implement change control procedures for supplier changes, including notification to relevant stakeholders.
6. Supplier Relationship Management:
   • Establish open communication channels with suppliers to address issues, share feedback, and promote continuous improvement.
   • Conduct periodic supplier performance reviews and discuss opportunities for collaboration and enhancement.

Abbreviations

• QA – Quality Assurance
• QC – Quality Control
• GDP – Good Distribution Practice

Documents

Reference documents related to supplier qualification and management may include:

• Supplier qualification criteria
• Supplier audit reports
• Quality agreements
• Approved supplier lists
• Supplier performance scorecards
• Change control records

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0