Preparing for Regulatory Scrutiny: Mock EU GMP Inspection and Remediation
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 that had invested in a new sterile product manufacturing facility and wanted to gain regulatory approval to supply products 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.”
Ready to Achieve Unmatched GMP Compliance and Inspection Readiness?
Proactively assure your facilities, systems, processes and procedures are fully compliant with EU GMP. EPiC stands as your trusted partner, offering thorough mock inspections proven to uncover GMP compliance gaps, weaknesses and deficiencies and offering recommendations for improvement.
What EPiC Delivers:
- In-depth Mock Inspections: Comprehensive evaluation mirroring real EU GMP regulatory requirements, identifying and advising on how to rectify any compliance gaps.
- Tailored Remediation Support: Corrective action plans created by former MHRA Inspectors and industry experts, encompassing both remote and on-site strategies.
- Inspection Readiness Training: Enhance staff preparedness with specialist training on EU GMP requirements, inspection processes, and adept presentation to inspectors.
Are You Ready to Elevate Your Inspection Readiness?
The journey to sustainable compliance and regulatory approval begins here. Contact EPiC today for a bespoke consultation that will set you on the right path
Begin Your Consultation – Prepare to outshine in your next EU GMP inspection.