US-Based R&D GMP Facility Mock EU GMP Inspection

Project Brief:   

EPiC received a request for support from a US-based pharma company that wanted a mock EU GMP inspection of their R&D facility to assess compliance and readiness for an anticipated EU GMP regulatory inspection by an EU regulatory agency.  

The R&D site had not previously been subjected to a regulatory inspection, and so the aim of the mock EU GMP inspection was to provide an independent expert assessment on the current level of compliance with EU GMP requirements applicable to IMPs, and to provide an opportunity for the site to experience hosting a regulatory inspection.

What EPiC Did:

  • We were able to offer a free 30 mins MS Teams call to find out more about the project to gain a clear understanding of the scope, expertise required, and timelines.  
  • We drafted a detailed proposal for the client to confirm the project scope and costs and included CVs for the consultants available to support the project.  
  • Once the proposal was accepted, the consultants worked with the client’s QA Manager to agree the mock inspection plan and logistical arrangements.  
  • The mock inspection involved two consultants working in parallel across two different sites to assess the pharmaceutical quality management system, operations and procedures relating to API and , Drug Product manufacturing, secondary packaging and QC testing , for compliance with current EU GMP regulations and guidance applicable to IMPs. 
  • During the mock inspection, the consultants adopted a hats on/hats off approach, which enabled wide-ranging discussions during the visit. 
  • We provided a detailed mock inspection report outlining the compliance concerns and gaps that would need to be addressed in readiness for an EU GMP regulatory inspection and made recommendations for dealing with these. 

Client Feedback:  

“Thank you for helping us prepare for the regulatory inspection next year.  It was a pleasure working with you and I know the team really enjoyed having you on site.” 

“Thank you for sending the mock inspection report. The team will be happy to see it and begin minimizing risk before the EU regulator is onsite next year.  Again, many thanks for all the expertise that the consultants shared with us during the mock inspection.  I personally learned a lot during this process, and I know others did as well.”