Regulatory Inspection Readiness Support for a New Sterile Product Manufacturing Facility in China

Project Brief:

EPiC received a request from a pharmaceutical company in China who had invested in a new sterile product manufacturing facility and wanted to gain regulatory approval to supply product to the UK and EU.

The initial request was to perform an onsite mock EU GMP inspection to assess compliance with EU GMP regulatory requirements. Depending on the outcome of the mock inspection, remediation support was also requested to address any weaknesses in preparation for an EU GMP regulatory inspection.

What EPiC Did:

  • We prepared for and conducted an onsite mock EU GMP inspection of the relevant manufacturing operations and associated controls for compliance with current EU GMP regulations and applicable guidance for sterile medicinal products.
  • We identified a number of weaknesses in the company’s systems, processes and procedures for sterility assurance and sterilization that would need to be addressed in preparation for an EU GMP regulatory inspection.
  • We developed a comprehensive package of remote and onsite remediation support to assess and improve sterility assurance and autoclave sterilization practices, governance and guidance.  The remediation package required input from a number of ex MHRA Inspectors as well as engineering and utilities support from ex industry experts.
  • We adopted a phased approach to co-ordinate multiple remediation workstreams across different sites, which involved a remote discovery and scoping phase, followed by a combined remote and onsite phase providing practical support with assessment, recommendations and  remediation assistance.
  • We delivered a remote training programme relating to the manufacture of sterile medicinal products designed to address knowledge gaps and improve awareness of EU GMP requirements.
  • We provided remote inspection readiness training for a range of personnel likely to be involved in the regulatory inspection covering a range of topics including an overview of the MHRA/EU inspection process and what to expect, general preparation points for all staff, specific tips for front-room and back-room organisation, guidance on presenting information to an Inspector, and specific advice and coaching for subject matter experts (SMEs).
  • We provided on-site, back-room support and coaching during the inspection.

Client Feedback:

“The MHRA inspection went very well, the Inspectors did not raise any Major or Critical deficiencies. The site team very much appreciated all the help from the consultants and EPIC team.”