Supplier Qualification and Approval – Standard Operating Procedure

1) Purpose

To establish a systematic process for qualifying and approving suppliers to ensure procurement of high-quality materials and services.

2) Scope

This SOP applies to all activities involved in supplier qualification and approval within the pharmaceutical purchase department.

3) Responsibilities

Procurement Manager: Responsible for overseeing the supplier qualification and approval process.
Purchasing Team: Responsible for executing the steps outlined in this SOP.

4) Procedure

4.1) Supplier Evaluation Criteria Development:
4.1.1) Define criteria such as quality standards, regulatory compliance, delivery reliability.
4.1.2) Determine documentation requirements for suppliers.

4.2) Supplier Pre-Qualification:
4.2.1) Collect necessary documentation from potential suppliers.
4.2.2) Assess initial suitability based on pre-defined criteria.

4.3) On-Site Audit:
4.3.1) Schedule and conduct on-site audits for qualified suppliers.
4.3.2) Evaluate facilities, processes, and quality systems.

4.4) Evaluation Report:
4.4.1) Document findings from audits and evaluations.
4.4.2) Prepare a summary report for review and approval.

4.5) Approval Decision:
4.5.1) Review evaluation reports and audit findings.
4.5.2) Make a decision on supplier approval based on established criteria.

5) Abbreviations, if any

N/A

6) Documents, if any

• Supplier Evaluation Forms
• Audit Reports
• Approval Forms

7) Reference, if any

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

8) SOP Version

Version 1.0