FDA General Inspection Checklist & Working Forms

FDA General Inspection Checklist & Working Forms

cGMP Surveillance Readiness — FD-AID, LLC

When an FDA Investigator asks how you know a system is working, your team needs evidence that supports the answer. This toolkit helps you examine that evidence, identify weaknesses, and document what requires action before a routine drug cGMP inspection.

Developed by a former FDA Investigator, the checklist follows an inspection approach built around reviewing Quality oversight, walking operations, tracing batches, examining original records, and assessing the significance of failures.

What’s included:

• 127 assessment checkpoints organized around the six cGMP systems, with a data integrity overlay, an optional sterile surveillance screen, and inspection-conduct readiness.
• Specific evidence requests, Investigator-style follow-up questions, and acceptance criteria to help evaluate actual implementation.
• Regulatory references and identified guidance support, with requirements distinguished from recommended assessment practices.
• 13 editable working forms for evidence selection, findings, product impact, CAPA effectiveness, prior commitments, batch tracing, inspection requests, and assessment summaries.
• A practical user guide and completed illustrative example showing how to connect evidence, findings, risk, and follow-up.

Use it for internal assessments, mock inspections, periodic cGMP reviews, and relevant contract-site oversight. Record what was examined, explain the gap, assess potentially affected product, and verify whether corrective actions worked.

Designed for: Quality leaders, QA professionals, internal auditors, pharmaceutical consultants, and finished-drug manufacturing teams.

Digital download: Editable Word checklist and forms, plus a user guide. The assessment can be completed using these documents and your existing quality system.

Scope: Routine finished-pharmaceutical cGMP surveillance. Specialized operations require their applicable supplemental assessments; the sterile module is an initial screen.

Independent industry assessment tool. Not issued, approved, endorsed, or required by FDA. Use does not guarantee compliance or an inspection outcome.