EPIC Auditors are delighted to welcome ex MHRA Inspector Tony Orme to the team as an independent consultant.
Tony has over 32 years’ experience at the MHRA working in various areas of regulation of medicinal product supply chains. As a former MHRA GDP Inspector, with 22 years within the MHRA GDP Inspectorate team where he reached Expert Inspector level, he undertook the most high profile and complex inspections across the UK.
Tony was the GDP EU Exit Lead and formulated the post Brexit guidance for import from listed countries, the RPi role and supply to Northern Ireland. He led on the implementation of the Falsified Medicines Directive for distributors in the UK and the continued use of the Medicines Verification system in Northern Ireland.
During his career at the MHRA Tony was involved in the development of most UK GDP policies, including the GDP risk based inspection strategy and supply chain security. He was GDP lead for IAG cases for many years and is ideally placed to help distributors ensure their operations are compliant or help respond to failures and to develop and implement effective remedial actions.
With his comprehensive portfolio of experience, Tony is an excellent addition to the EPIC team.
I have known and worked with Tony for over 20 years and am delighted that he has joined the EPiC team of Experts as an independent consultant. His knowledge and experience of GDP and supply chain security is second to none.
As announced last week at the MHRA Symposium 2023 the GDP Inspectorate are moving to a licence based inspection model, whereby the overall compliance of all sites named on a WDA(H) will be determined from the inspection outcomes of a selected sample of the sites. In implementing this approach, the GDP Inspectorate will be making greater use of unannounced and short notice inspections. Ensuring all sites are in a constant state of inspection readiness is therefore now even more important.
Through EPiC, Tony and the other former MHRA GDP Inspectors, who also work as independent consultants for us, can conduct regular and routine mock inspections and audits to help you maintain the required level of compliance and ultimately be inspection ready.
Richard Andrew, EPiC Director & Senior Consultant
Pharmaceutical Industry Experts
Auditors used by EPIC are former Regulatory Inspectors, typically ex MHRA Inspectors. All auditors have extensive industry experience and many years of experience auditing and inspecting within the pharmaceutical industry.
To read the bio and full CV for Tony Orme and our other experts’ visit Meet Our Experts
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