Vendor Selection Criteria – Standard Operating Procedure

1) Purpose

To define criteria and processes for selecting vendors who meet the pharmaceutical purchase department’s standards for quality, reliability, and compliance.

2) Scope

This SOP applies to the vendor selection process within the pharmaceutical purchase department.

3) Responsibilities

Procurement Manager: Responsible for defining and updating vendor selection criteria.
Purchasing Team: Responsible for applying criteria and selecting vendors.

4) Procedure

4.1) Criteria Development:
4.1.1) Define vendor selection criteria based on quality, regulatory compliance, delivery reliability, and pricing.
4.1.2) Establish minimum requirements for vendor qualification.

4.2) Vendor Evaluation:
4.2.1) Assess potential vendors against established criteria.
4.2.2) Conduct pre-qualification assessments as necessary.

4.3) Selection Decision:
4.3.1) Compare and evaluate vendors based on evaluation results.
4.3.2) Select vendors who best meet departmental needs and standards.

4.4) Documentation:
4.4.1) Maintain records of vendor evaluations and selections.
4.4.2) Update vendor lists and databases accordingly.

5) Abbreviations, if any

N/A

6) Documents, if any

• Vendor Selection Criteria Matrix
• Evaluation Forms
• Vendor Qualification 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