Supplier Qualification Procedure

Purpose

The purpose of this SOP is to establish guidelines for qualifying and evaluating suppliers of pharmaceutical products to ensure the quality, reliability, and compliance of the pharmaceutical supply chain.

Scope

This SOP applies to all personnel involved in the supplier qualification process within the pharmaceutical company.

Responsibilities

• Procurement Manager: Overall responsibility for implementing supplier qualification procedures and ensuring compliance.
• Quality Assurance: Responsible for assessing supplier quality and compliance with regulatory requirements.
• Supplier Relationship Manager: Responsible for maintaining relationships with approved suppliers and monitoring performance.
• Finance Department: Responsible for evaluating supplier financial stability and negotiating contracts.

Procedure

1. Supplier Identification:
   • Identify potential suppliers based on product requirements, quality standards, and regulatory compliance.
   • Conduct market research and supplier evaluations to identify suitable candidates.
   • Consider factors such as reputation, experience, and capabilities when selecting suppliers.
2. Supplier Qualification:
   • Request and review supplier documentation, including licenses, certifications, and quality management systems.
   • Conduct on-site audits or inspections of supplier facilities to assess compliance with GMP (Good Manufacturing Practice) standards.
   • Evaluate supplier performance based on past performance, quality incidents, and customer feedback.
3. Contract Negotiation:
   • Negotiate terms and conditions with approved suppliers, including pricing, delivery schedules, and quality requirements.
   • Ensure that contracts include provisions for quality assurance, compliance, and dispute resolution.
   • Review and finalize contracts with legal and finance departments to ensure compliance with company policies and regulations.
4. Supplier Approval:
   • Review supplier qualification documentation and audit reports to make a decision on supplier approval.
   • Document the approval or rejection of suppliers and the rationale for the decision.
   • Communicate the approval status to relevant stakeholders and update supplier databases accordingly.
5. Supplier Monitoring and Review:
   • Monitor supplier performance on an ongoing basis through key performance indicators (KPIs) and metrics.
   • Conduct periodic supplier reviews and audits to assess continued compliance and identify areas for improvement.
   • Address any supplier issues or non-conformance promptly through corrective and preventive actions.

Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• KPIs: Key Performance Indicators

Documents

• Supplier Evaluation Form
• Supplier Audit Report
• Supplier Contracts
• Supplier Approval/Rejection Documentation
• Supplier Performance Review Reports

SOP Version

Version 1.0