Supplier Qualification – Standard Operating Procedure

1) Purpose

To establish guidelines for qualifying suppliers based on their capability, quality systems, and compliance with regulatory requirements within the pharmaceutical purchase department.

2) Scope

This SOP applies to the process of evaluating and qualifying suppliers to ensure they meet specified criteria for procurement of materials and services.

3) Responsibilities

Purchasing Team: Responsible for supplier selection and qualification.
Quality Assurance Team: Responsible for assessing supplier quality systems and compliance.

4) Procedure

4.1) Supplier Selection:
4.1.1) Define criteria for selecting suppliers including quality, regulatory compliance, delivery performance, and financial stability.
4.1.2) Conduct initial assessments based on supplier capabilities and suitability.

4.2) Supplier Evaluation:
4.2.1) Collect and review supplier information such as quality manuals, certifications, and audit reports.
4.2.2) Evaluate supplier performance history and ability to meet specified requirements.

4.3) On-Site Assessment:
4.3.1) Conduct on-site visits or audits to verify facilities, processes, and quality systems.
4.3.2) Assess compliance with regulatory requirements and industry standards.

4.4) Qualification Decision:
4.4.1) Determine qualification status based on evaluation findings and risk assessment.
4.4.2) Document supplier qualification decisions and notify suppliers accordingly.

4.5) Supplier Performance Monitoring:
4.5.1) Monitor ongoing supplier performance through metrics and periodic reviews.
4.5.2) Initiate corrective actions or re-evaluation as necessary based on performance.

4.6) Documentation and Records:
4.6.1) Maintain records of supplier qualification assessments, evaluations, and decisions.
4.6.2) Archive supplier qualification documentation for regulatory inspections and audits.

5) Abbreviations, if any

N/A

6) Documents, if any

• Supplier Qualification Criteria
• Supplier Evaluation Reports
• On-Site Assessment Reports
• Supplier Qualification Status Records

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211.84, ICH Q7
Industry Standards: ISO 9001:2015

8) SOP Version

Version 1.0