Pharmaceutical Supplier Qualification Audit Checklist
Supplier qualification is a critical GMP requirement ensuring that raw materials meet specifications and are manufactured under acceptable quality conditions. This audit checklist covers all elements of supplier qualification per FDA 21 CFR 211.84 and ICH Q10.
- Industry: Pharmaceutical & Life Sciences
- Frequency: Annual / Per New Supplier
- Estimated Time: 45-60 minutes
- Role: Quality Assurance Manager / Procurement Specialist
- Total Items: 31
- Compliance: FDA 21 CFR 211.84 - Testing and Approval or Rejection of Components, Drug Product Containers, and Closures, ICH Q10 Section 3.2.3 Management of Outsourced Activities, FDA Guidance for Industry - Contract Manufacturing Arrangements for Drugs (2016), EU GMP Chapter 7 Outsourced Activities
Supplier Quality System
Assess supplier GMP/ISO quality system.
- Supplier holds current GMP certificate or ISO 9001 certification?
- Supplier has no current FDA warning letters, import alerts, or regulatory sanctions?
- Supplier Site Master File (SMF) or equivalent quality documentation available?
- Quality manual or quality policy reviewed?
- Evidence of management review of quality system performance?
Manufacturing Controls
Assess supplier manufacturing GMP controls.
- Manufacturing process validated with documented validation reports?
- Change control system with customer notification for changes affecting supplied materials?
- Deviation and CAPA system with investigation quality?
- Appropriate environmental controls for material being produced?
- Cross-contamination prevention controls for multi-product facilities?
Material Specifications and Testing
Review specification and testing controls.
- Written specifications for supplied material including all required attributes?
- Certificate of Analysis provided for each lot with results vs specifications?
- Identity testing performed on 100% of API lots per FDA 21 CFR 211.84(d)(1)?
- Impurity and residual solvent testing per applicable ICH guidelines?
- Elemental impurity testing per ICH Q3D if applicable?
Quality Agreement
Review quality agreement with supplier.
- Quality Agreement (Technical Agreement) in place with supplier?
- Quality agreement specifies supplier change notification requirements?
- Quality agreement grants audit rights to purchasing company?
- Quality agreement current and signed within past 2-3 years?
- Recall and complaint handling provisions in quality agreement?
Supply Chain Integrity
Assess supply chain security and counterfeit prevention.
- Source of starting materials and sub-contractors documented?
- Supplier's own critical sub-suppliers qualified and monitored?
- Supply chain fully mapped to identify all entities handling material?
- Anti-counterfeiting measures in place for APIs?
- Distribution and chain of custody documentation provided?
Ongoing Monitoring and Performance
Document ongoing supplier monitoring.
- Annual supplier performance review completed?
- CoA review for each incoming lot per receiving procedure?
- Skip-lot testing program based on supplier qualification and track record?
- Supplier-related complaints and deviations tracked and communicated?
- Supplier on Approved Supplier List (ASL)?
- Supplier qualification audit report prepared and filed?
Related Pharmaceutical Life Sciences Checklists
- Pharmaceutical Cold Chain and Temperature-Sensitive Logistics Inspection Checklist
- Pharmaceutical Packaging Materials Audit and Inspection Checklist
- Pharmaceutical Incoming Material Sampling and Testing Checklist
- GxP Training Compliance and Competency Audit Checklist
- FDA Inspection Readiness Assessment Checklist
- Pharmaceutical Product Recall Readiness Checklist
- FDA GMP Inspection Readiness Audit Checklist
Related Supply Chain Checklists
- Pharmaceutical Cold Chain and Temperature-Sensitive Logistics Inspection Checklist - FREE Download
- Pharmaceutical Packaging Materials Audit and Inspection Checklist - FREE Download
- Pharmaceutical Incoming Material Sampling and Testing Checklist - FREE Download
Why Use This Pharmaceutical Supplier Qualification Audit Checklist?
This pharmaceutical supplier qualification audit checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for quality assurance manager / procurement specialist professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: annual / per new supplier.
Ensures compliance with FDA 21 CFR 211.84 - Testing and Approval or Rejection of Components, Drug Product Containers, and Closures, ICH Q10 Section 3.2.3 Management of Outsourced Activities, FDA Guidance for Industry - Contract Manufacturing Arrangements for Drugs (2016), EU GMP Chapter 7 Outsourced Activities. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Pharmaceutical Supplier Qualification Audit Checklist cover?
This checklist covers 31 inspection items across 6 sections: Supplier Quality System, Manufacturing Controls, Material Specifications and Testing, Quality Agreement, Supply Chain Integrity, Ongoing Monitoring and Performance. It is designed for pharmaceutical & life sciences operations and compliance.
How often should this checklist be completed?
This checklist should be completed annual / per new supplier. Each completion takes approximately 45-60 minutes.
Who should use this Pharmaceutical Supplier Qualification Audit Checklist?
This checklist is designed for Quality Assurance Manager / Procurement Specialist professionals in the pharmaceutical & life sciences industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.