EPIC Auditors are delighted to welcome 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

If you need our help and support then please contact us on +44 (0)1244 980544 or e mail us at

Lewis Corbett joins EPiC as Business Manager & Senior Consultant

EPIC Auditors are delighted to announce that Lewis Corbett has joined EPiC Auditors as Business Manager and Senior Consultant.

Lewis has over 25 years experience of pharmaceutical manufacture and distribution gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA) as a Senior GMP Inspector and Head of GMP Team 1. During his 5 years at the MHRA Lewis had responsibility for the licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, managing and leading a team of GMP Inspectors, implementing changes to regulations and ways of working as a result of EU Exit, and supporting elements of the agency’s Covid-19 pandemic response. 

Prior to joining the MHRA Inspectorate Lewis spent 22 years working in the pharmaceutical industry in various QC, QA and management roles, and as a Qualified Person for a range of active pharmaceutical ingredients and non-sterile product dosage forms.

Lewis was trained and accredited by the MHRA to inspect:

• API manufacturers, importers and distributors  
• Importation of medicinal products 
• Non-Sterile manufacturing sites   
• Contract laboratories   
• Excipient manufacturers  
• Storage and distribution sites

He has expertise in MHRA and EU Inspection preparation and remediation, Pharmaceutical Quality Management Systems, and training in EU GMP Regulatory requirements and is eligible to act as an EU Qualified Person.

With his wide portfolio of experience, Lewis is a great addition to the core EPiC team and with his help we are confident we can extend our GXP support across the medicinal product lifecycle and help all our clients to improve their GXP quality systems and regulatory compliance.

If you need our help and support then please contact us on +44 (0)1244 980544 or e mail us at 

EPiC Auditors Autumn Compliance Seminar: Thursday 10th November 2022

Here’s what our speakers have to say about the event;

“A condition of holding an MIA and WDA(H) is that the guidelines on GMP and GDP are complied with. Sustaining the required level of compliance is a must to ensure medicinal products of the right quality are manufactured and distributed and avoid regulatory action. My presentation on Future-proofing compliance will explore what licence holders can and should do to continually improve and not only fulfil but exceed this requirement.” 

Richard Andrews, EPiC Auditors Managing Director & Senior Consultant   

With the deadline for the implementation of Annex1 fast approaching, now is a great time to consider the implications for your sterile processes.  At the EPiC Autumn Compliance Seminar, I will roadmap those areas of the new Annex 1 that may result in many future sterility assurance deficiencies – a roadmap of the hotspots. This session will complement the session from Rick Parker of the MHRA, who will provide the latest MHRA thinking on Annex 1. A great opportunity to get ahead of the Annex 1 changes!

Darren Jones, EPiC Auditors Director & Senior Consultant

To find out more about the seminar and to book your tickets click on the link below:

“you say tomato, I say tomahto” 🍅

Regardless of what we are calling our Autumn Compliance Seminar/ Symposium!

This online conference will be a full day event delivered remotely, packed with a programme of informative sessions and presentations brought to you by current & ex MHRA Inspectors, providing advice on a wide range of hot topics guaranteed to get you thinking and an opportunity to start a discussion and ask your own burning questions! 🔥🔥🔥

Unlike other conventions, our seminar on Thursday 10^th November will not be a lecture but a thought provoking and informative colloquium with a few laughs along the way!

There’s only 2 weeks to go – don’t suffer FoMo, be sure not to miss out!

Get your tickets here;

In collaboration with SeerPharma UK

You may also be interested in the SeerPharma UK GDP Symposium taking place on Tuesday 8^th November 2022: Register and Pay Online Here

EPiC Auditors Autumn Compliance Seminar: Thursday 10th November 2022

Here’s what our speakers have to say about the event;

 “How to achieve Regulatory compliance for small, new and innovative companies can seem an impossible task. How to maintain compliance for well established global companies can be equally challenging. We hope this seminar provides some useful advice and solutions for all pharmaceutical companies, whatever stage of maturity they are at. We look forward to delivering our second online conference and sharing our thoughts gained from our previous MHRA experiences, as well as from our recent projects within EPIC.”

Liz Allanson, EPiC Auditors Director and Senior Consultant

The transitional measures in place to support implementation of the Clinical Trials Regulation which replaces the Clinical Trials Directive are rather complex, and it can be confusing for clinical trial teams to know which sets of documents and requirements should be referred to depending on the location and legislation under which the clinical trial is conducted. This presents risks to compliance and a need for Sponsors to ensure that they have adaptable systems to cope with the flexibility of risk proportionate approaches proposed by MHRA, without overlooking trial specific or regulatory requirements for EU trials. At our Autumn Compliance Seminar, myself and Louise Mawer (ex MHRA Senior GCP Inspector) will be providing practical advice and real-world examples for Sponsors and clinical trials teams on key aspects of managing clinical trial activities during the legislative transitional phase.We will also be reflecting on the challenges for clinical trial supply chains following the UK’s exit from the EU, to help those involved in clinical trial supply understand the GMP expectations for IMPs, non-IMPs and QP certification requirements. The transitional implementation phase of the Clinical Trials Regulations has presented additional challenges at the IMP/GCP interface, and we hope our session will raise awareness of the different terminology and expectations to help maintain compliance with the changing requirements.

Michelle Yeomans, EPiC Auditors Operations Manager  

To find out more about the seminar and to book your tickets click on the link below: