Following on from the how to prepare for a regulatory inspection advice we shared during our recent virtual symposium, one of EPiC’s GMP consultants has recently returned from helping a client in California with their inspection readiness activities in preparation for the site’s first EU GMP regulatory inspection.
The on-site consultancy support provided the opportunity for the inspection hosts and subject matter experts (SMEs) to gain an appreciation of the EU GMP inspection process style and what to expect. It highlighted general points for all staff as well as some specific Do’s and Don’ts.
Newfound Confidence
The visit provided recommendations for the management of the inspection with respect to hosting, tour, and the ‘back room’ logistics and provided the opportunity to practice the inspection document request system. The facility tour focused on identifying key GMP issues so that the consultant could work with the SMEs to develop recommendations to address any issues and provided an opportunity for the SMEs to practice presenting information to an inspector.
The client reported that our consultant had been “an amazing asset by highlighting some gaps, conveyed the likely criticality of those gaps, and provided recommendations on how to address.” The inspection readiness support has given the site a newfound confidence to approach the inspection with a realistic yet positive mindset.
The client reported that “whilst we know we will have some observations, we now feel confident that the site will show well and will be able to demonstrate that we are in a state of control”, which all bodes well for a successful inspection outcome.
Are you Inspection Ready?
Take a look at our recent top-tip article by Michelle Yeomans focusing on Inspection Readiness to help you stay calm and be prepared!
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