How to Audit Suppliers for GMP Compliance

A Step-by-Step Guide to Auditing Suppliers for GMP Compliance

Introduction to Supplier Audits in GMP

The Importance of Supplier Audits in Pharmaceutical Manufacturing

Supplier audits are essential in GMP compliance to ensure that raw materials and components used in pharmaceutical products meet quality standards. A robust supplier audit program helps manufacturers verify that suppliers adhere to GMP practices, reducing the risk of contamination, delays, and regulatory non-compliance. This how-to guide provides step-by-step instructions for conducting effective supplier audits.

Steps to Audit Suppliers for GMP Compliance

1. Prepare an Audit Plan

An audit plan outlines the scope, objectives, and timeline for

the audit.

Define Audit Scope: Identify areas to be audited, such as quality management systems, production processes, or warehousing.
Assign Audit Team: Select auditors with experience in GMP compliance.

Also Read: How to Prepare for PMDA GMP Inspections in Japan

2. Conduct a Pre-Audit Questionnaire

A pre-audit questionnaire helps gather preliminary information about the supplier’s operations.

Assess Key Processes: Request details about the supplier’s quality control procedures.
Review Documentation: Ask for certificates of analysis (CoAs) and recent audit reports.

3. Perform On-Site Audit

During the on-site audit, the team evaluates the supplier’s facilities and operations.

Facility Inspection: Assess cleanliness, equipment calibration, and material storage conditions.
Interview Personnel: Interview key staff to verify their understanding of GMP practices.

4. Identify Non-Conformities

Non-conformities are areas where the supplier fails to meet GMP standards.

Classify Issues: Categorize non-conformities based on their severity (critical, major, minor).
Document Findings: Provide detailed descriptions of non-conformities in the audit report.

Also Read: Role of GMP in preventing contamination

5. Develop Corrective Action Plans (CAPA)

Work with the supplier to create corrective action plans to address non-conformities.

Set Deadlines: Establish timelines for implementing corrective actions.
Monitor Progress: Follow up regularly to ensure corrective actions are completed.

Conclusion

Auditing suppliers is crucial for maintaining GMP compliance and ensuring product quality. A well-structured audit program helps manufacturers identify risks early, promote continuous improvement, and build stronger supplier relationships.