2026 GxP Inspection Readiness Checklist
A practical self-assessment for pharmaceutical and biotech teams preparing for an FDA, Health Canada, MHRA or EU inspection, a customer audit or partner due diligence. Written by consultants who have worked inside regulated quality functions.
What's Inside
Eight Areas Inspectors Focus On
- Quality system and management oversight
- Documentation and data integrity (ALCOA+, Part 11 / Annex 11)
- Deviations, CAPA and change control
- Training and personnel
- Facilities, equipment and validation
- Suppliers and outsourced activities
- Product quality, complaints and clinical oversight
- Inspection logistics and people
Plus a 90 / 60 / 30-day readiness timeline and an action-plan template. 3 pages, printable PDF.
Get Your Free Copy
Thank you — your download has started.
If it didn't, click here to download the checklist.
Want an independent review before your inspection? Book a free 20-minute discovery call.
If it didn't, click here to download the checklist.
Want an independent review before your inspection? Book a free 20-minute discovery call.
Need More Than a Checklist?
Independent Inspection Readiness Support
A checklist shows you where to look; an experienced auditor shows you what an inspector will see. Our gap assessments and mock inspections and quality assurance services help you close gaps with confidence before inspection day.