GUIDANCE
1. Review the quality system
Confirm that SOPs, policies and quality processes are current, approved and actually followed. Review CAPA, deviations, change control, complaints, training and management review for overdue or recurring issues.
LH QUALITY CONSULTING RESOURCE
FDA Inspection Readiness Checklist
Preparing for an FDA inspection is less about creating a perfect binder and more about knowing whether your quality system can withstand questions about how work is actually performed. This checklist helps pharmaceutical and biotech teams organize the most important areas before an inspection.
GUIDANCE
2. Review critical records
Check that batch records, laboratory records, validation documentation, investigations and other critical records are complete, attributable, legible and readily retrievable.
GUIDANCE
3. Assess open issues
Create a risk-based list of open deviations, CAPAs, complaints, audit observations and commitments. Make sure owners, due dates, impact assessments and effectiveness checks are clear.
GUIDANCE
4. Prepare your people
Identify subject-matter experts and ensure they understand their responsibilities. Practice concise, factual responses and document retrieval without coaching people to memorize answers.
GUIDANCE
5. Conduct a mock inspection
Simulate requests for procedures, records and evidence. Track how quickly the team can find information and whether different functions give consistent answers.
GUIDANCE
6. Close high-risk gaps
Prioritize issues that could affect product quality, patient safety, data integrity or regulatory compliance. Document remediation and retain objective evidence that actions were completed and effective.
NEED EXPERT SUPPORT?