It is vital that organisations prepare themselves ahead of regulatory authority inspections for GMP, GDP, GCP or GPvP.
There are two fundamental aspects to consider in the preparation:
- Documentation applicable to the inspection is present, complete and meets ALCOA+ principles.
- All personnel are mentally prepared by keeping calm, truthful, professional and polite at all times and come together as a team. Especially those that will be supporting on the day/s of the inspection.
An inspection readiness checklist must be created as soon as you are aware of an inspection, to ensure, documentation, premises, equipment and personnel are ready. This training video will take you through the main topics to consider in preparation for a regulatory authority inspection.
Written by: Sanjay Nadarajah, GMP/GDP Consultant