Audit Support for International Corporate Audit Programme

EPiC received a request from a multinational speciality pharma company to provide expertise and resources to support their corporate audit program.  

The company specifically wanted to work with EPiC’s consortium of ex MHRA Inspectors so that the audits would mimic a health authority inspection such as those performed by the MHRA or US-FDA.

What EPiC Did:

  • Our Business Development Manager worked with the Company’s Quality & Compliance Director to review the audit program to understand the scope and technical competencies required to support the program, which required a mixture of on-site audits of sterile and non-sterile drug manufacturing sites in the EU, Americas, and Dubai, as well as remote audits of corporate functional areas.
  • We agreed the split of responsibilities, with the client being responsible for providing preparatory information to facilitate the audit, and EPiC responsible for coordinating the audit, contacting the auditee, arranging the logistics, and for preparing, performing and reporting the audit.
  • We identified appropriate experts with the required technical competencies and availability to support the audit timings and drafted a detailed proposal for each audit. The audit scope was to cover the full range of the site or corporate function operations, assessing their compliance with internationally recognised standards of Good Manufacturing Practice and Good Distribution Practice as applicable.     
  • We provided a detailed audit report equivalent in content to a health authority inspection report to enable the client to submit the report to the auditee, complete follow up and CAPA oversight and decide on the next audit date.

Client Feedback:

“We look forward to your processes as this new approach of using external SME consultants is definitely something we wanted to do to get out of the old norms that had been established by our previous systems.”

“We very much appreciate your partnership with our company and look forward to our ongoing relationship!”