GMP Audit Checklist For Drug Manufacturers

Disclaimer

The checklist contained herein is intended solely as a reference tool to assist auditors in conducting GMP compliance audits. It does not constitute legal advice, regulatory guidance, or a comprehensive audit methodology, and should not be construed as such.

Use of this checklist does not guarantee regulatory compliance, nor does it substitute for proper audit planning, professional judgment, or auditor training. Completion of this checklist in full does not imply that all applicable cGMP requirements have been assessed, identified, or satisfied.

This tool is not a substitute for knowledge of current FDA regulations, guidance documents, or applicable industry standards. Questions and criteria contained herein may not reflect the most recent regulatory updates and should be verified against current requirements prior to use.

A satisfactory score or completed checklist should not be interpreted as confirmation of compliance. Serious deficiencies may exist outside the scope of this document. All findings, observations, and conclusions remain the professional responsibility of the auditor and the organization conducting the audit.

This checklist is provided as-is, without warranty of any kind, express or implied. The organization providing this tool assumes no liability for audit outcomes, regulatory findings, or enforcement actions arising from its use or misuse.

Instructions for Using Audit Checklist

1. Before beginning the on-site audit, plan the audit by reviewing previous audit findings, known problem areas, and applicable regulatory requirements for the product type being audited.
2. This checklist covers requirements applicable to drug products (21 CFR Parts 210 and 211), medical devices (21 CFR Part 820 / QMSR), and combination products. Mark sections N/A where a regulation does not apply to the facility or product.
3. Use the Yes / No / NA / Obs. column to record findings. Recommended codes: ✓ = Yes (conforming), X = No (nonconforming), N/A = Not Applicable, O = Observation requiring follow-up.
4. Record all significant observations, evidence reviewed, and supporting details in an audit notebook. Cross-reference notebook entries with item numbers on this checklist.
5. Ask open-ended questions (e.g., 'Show me how this procedure works') rather than simple yes/no questions. Walk through procedures step by step to confirm they are current, adequate, and followed.
6. Ask the auditee: 'Are there any areas of concern you would like me to examine?' This often surfaces issues not covered by the checklist.
7. Do not rely on this checklist as the sole basis for the audit. It is a guide, not a substitute for auditor expertise, judgment, and knowledge of current regulations.
8. At least three production batches should be selected for traceability analysis covering: (a) all components and materials, (b) in-process and finished product testing, and (c) warehousing and distribution records.