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Case Study: Mock EU GMP Inspection & Remediation

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.

Case Study: Product Safety and Pharmacovigilance (PV) System

EPiC received a request from a large pharma group of companies that, following a series of mergers and acquisitions, was establishing a new UK entity and needed to establish a standalone PV system for the new entity in preparation for the transition.

Case Study: Review of Facility Plans

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.

Aseptic
Case Study: GMP Consultancy

EPiC received a request for support from a UK-based aseptic compounding unit to provide GMP consultancy to help the company respond to Critical and Major inspection deficiencies identified during a short-notice MHRA GMP inspection. 

Case Study: Inspection Readiness

EPiC received a request for support from a US based pharma company who 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.