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