New UK non-sterile Investigational Medicinal Products (IMP) Facility

Project Brief:

EPiC received a request from a manufacturer of non-sterile IMPs to review plans for a new facility. The new site had an established footprint and the client had designed the manufacturing rooms and supporting areas to fit the space but wanted an expert review of the plans to assess their compliance with EU GMP requirements before any building work was undertaken.

Once the new facility was operational, we received a further request to conduct a mock MHRA GMP inspection to assist the site in preparation for a MHRA MIA(IMP) licence application.

What EPiC Did:

  • We provided a remote review of the plans for the new facility and the associated personnel and product flows for compliance with EU GMP requirements.
  • We provided a written report identifying any concerns or deficiencies along with suggestions for addressing these.
  • During the commissioning and qualification of the new facility, our consultant worked with the company’s Quality Director to agree the scope and agenda for a mock MHRA GMP inspection of the pharmaceutical quality management system, manufacturing facilities, processes and procedures for compliance with current EU GMP guidance and regulations applicable to the manufacture of non sterile IMPs.   
  • We provided a detailed mock inspection report outlining the compliance concerns and gaps that would need to be addressed in readiness for a MHRA MIA(IMP) GMP inspection and made recommendations for dealing with these.

Client Feedback:

“Thank you for getting the design review summary report to us so quickly it is really appreciated. The conversation with the consultant was extremely constructive and useful for us.”

“We were very happy with the service, the consultant was excellent in their support of our requirements.”

“It was invaluable to us to understand an inspectors perspective, mindset and approach to the project we are managing and this was provided by the consultant.”