How long before an EMA inspection should the readiness assessment start?
A typical pre-inspection readiness assessment starts 2-3 months before the inspection.
EMA Inspection Support
EMA inspection support services for pharmaceutical manufacturers. The engagement covers the pre-inspection readiness, the mock inspection, the documentation preparation, the inspector response, the CAPA, and the post-inspection follow-up.
EU GMP readiness
The EU GMP readiness covers the documentation review, the system walkthrough, the interview preparation, the tour preparation, the data review, the CAPA review, and the inspector scenario.
Annex 11 and data integrity
The Annex 11 and data integrity readiness covers the computerized systems, the audit trail, the electronic signatures, the data lifecycle, the ALCOA+ principles, and the periodic review.
Mock inspection
The mock inspection covers the documentation request, the system walkthrough, the interview, the data review, the finding classification, and the CAPA recommendation.
How to use this page
Use this EMA Inspection Support page as a planning checkpoint before vendor selection, architecture review, validation scoping or implementation sequencing. The strongest next step is to compare the guidance with your current SOPs, system inventory, batch records, data flows and QA review routines so the discussion starts from evidence instead of assumptions.
Evidence to prepare
For EMA Inspection Support, prepare the records, owners, risks and decision criteria linked to eu gmp readiness, annex 11 and data integrity, mock inspection. Useful evidence includes current process maps, interface lists, audit trail expectations, exception workflows, data retention rules and the business reason for changing the current operating model.
Frequently asked questions
What is the difference between EMA and FDA inspection?
EMA inspections focus on the EU GMP, Annex 11. FDA inspections focus on the 21 CFR Part 11.