GMP Audit Checklist Form

A GMP audit checklist form documents a facility's compliance with Good Manufacturing Practice (GMP) standards across key control areas. It captures observations, non-conformances, corrective actions, and compliance status across areas including hygiene, equipment, documentation, and process controls. Think of it as the formal evidence record that demonstrates your facility operates in compliance with applicable GMP regulations.

GMP compliance requires documented evidence that your facility follows standards consistently, not just during an inspection. Without regular documented audits, your facility has no evidence of a compliance pattern when a regulator requests records. A structured form ensures every control point is assessed and recorded consistently, regardless of who conducts the audit. Use it for internal GMP audits, pre-inspection readiness assessments, supplier audits, and third-party compliance reviews.

Gather everything needed for a defensible compliance record:

• Facility and personnel hygiene (gowning, handwashing, illness reporting)
• Facility conditions (cleanliness, maintenance, pest control)
• Equipment qualification and maintenance records
• Raw material receipt, testing, and storage
• In-process controls and monitoring
• Cleaning and sanitization procedures and verification
• Documentation practices (completeness, accuracy, version control)
• Label control and reconciliation
• Deviation, non-conformance, and corrective action records
• Training records and competency verification
• Auditor name, date, and overall compliance rating

Use Typeform's File Upload feature to let auditors attach photos of non-conformances or facility conditions directly in the audit. Accepted file types include JPG, PNG, and PDF, with a 10MB limit per file. Photographic evidence arrives alongside each observation, so your quality team reviews findings without requesting supporting documentation separately. File Upload is available on paid Typeform plans.

Add a severity rating to each control point so every audit produces a trackable compliance score. Scoring each finding as critical, major, or minor gives your quality team a consistent basis for prioritizing corrective actions. Over time, scores reveal trends and help your team focus resources on the areas that need the most attention.