White Paper
The Inspection Readiness Playbook for GMP Manufacturing
How quality organizations get ready for an FDA or EMA inspection without pulling the whole site off its production schedule.
Overview
Inspection readiness fails for boringly predictable reasons. The documentation is technically complete but nobody can retrieve it under pressure. Subject matter experts have never been asked a hard question by someone outside the company. Open CAPAs tell a story the site would rather not tell.
The playbook works through the twelve weeks before an inspection, then the practices that decide how the day itself goes: front room and back room discipline, document retrieval drills, and how to prepare an SME who has never sat across from an investigator. There is a readiness assessment at the back you can run yourself, before deciding whether you need help from outside at all.
What you will learn
- Run a gap assessment against the observations investigators cite most often
- Set up front room and back room operations so requests come back in minutes
- Coach subject matter experts to answer the question asked, and nothing more
- Clear the CAPA backlog items that draw the most scrutiny
- Have a post-inspection response process ready before you need it
How Viltis helps
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The practices in this paper map to work our consultants deliver directly. If you would rather have it done than read about it, start here.
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