EPiC Auditors are delighted to announce that Ex MHRA inspector Philip Rose has joined the EPiC team as an independent consultant.

Ex MHRA inspector Philip has over 20 year’s pharmaceutical industry experience gained from his time working within the industry and through working for the MHRA for over 7 years, where he held the position of Lead Senior GMP Inspector. His expertise includes the manufacture of sterile and non sterile medicinal products, biologics, and ATMPs; inspecting and auditing nationally and internationally, training, presenting and mentoring on medicinal product manufacture and packaging and auditing and inspection of GMPs.

Philip is eligible to act as a Qualified Person and he has an in depth and current knowledge of regulatory guidance and the interpretation of it.

At EPiC, we pride ourselves on assembling a team of industry-leading professionals, and Ex MHRA inspector Philip is no exception. His extensive experience and expertise align perfectly with our commitment to excellence in auditing, regulatory compliance, and quality assurance within the pharmaceutical industry.

“Philip is highly respected within the pharmaceutical industry and along with our other former MHRA Inspector consultants he will be key in helping EPiC to deliver quality assurance services to our clients, ensuring they are compliant with all aspects of their operations. Having Philip as part of the EPiC team will be invaluable as we continue to develop our business.” 

Richard Andrew, EPiC Managing Director & Senior Consultant

To read the bio and full CV for Philip Rose and our other experts’ visit Meet Our Experts 

Pharmaceutical Industry Experts 

EPiC Auditors is a leading auditing and quality assurance consultancy firm specialising in the pharmaceutical industry. With a team of seasoned professionals, we provide comprehensive auditing services, regulatory compliance guidance, and expert insights to help pharmaceutical companies achieve and maintain the highest quality standards. Our mission is to ensure the safety, efficacy, and quality of pharmaceutical products, ultimately contributing to the well-being of patients worldwide.

If you need our help and support then please contact us on +44 (0)1244 980544 or e mail us at enquiries@epic-auditors.com 

We are thrilled to welcome Ex MHRA Inspector Alan Moon as an Independent Consultant at EPiC Auditors.

Alan Moon began his career in the pharmaceutical industry in February 1994 and has extensive experience of pharmaceutical manufacture, particularly associated with sterile products and investigational medicinal products (IMPs). He spent approximately 19 years working within the pharmaceutical industry before joining the UK Medicines Regulator (MHRA) in 2013.

During his ten years at MHRA Alan reached the level of Lead Senior Inspector and in addition to supporting the GMP Inspectorate’s risk-based inspection programme and being the nominated chair for the Compliance Management Team, he was also the technical lead within the GMP team for both sterile products and IMPs.

He was the principal UK representative for the GMP Annex 1 drafting group from 2019 through to its publication in August 2022, and continued to support the associated PIC/S inspector training group and participate in conferences on the subject until leaving the Agency in March 2023.

Alan was also part of the EU working group for the revision and update to GMP Annex 13 and as part of the UK’s exit from the EU, he prepared the framework and guidance for implementation of the UK MIA(IMP) oversight process for the import of QP-certified IMPs from listed countries into Great Britain, and the associated aspects relating to the Northern Ireland Protocol.

Prior to joining the MHRA GMP Inspectorate, Alan worked in a variety of roles within the pharmaceutical industry, including QA, QC Microbiology, Sterility Assurance, Validation and Production, with significant experience of aseptic and terminal sterilisation manufacturing processes.

Alan’s exceptional skills, extensive experience, and unique expertise make him the perfect addition to our team.

QUOTE FROM RICHARD ANDREWS

We are thrilled to welcome Ex MHRA inspector Alan as an independent consultant at EPiC Auditors. Having been involved with the manufacture and regulation of medicines for nearly three decades Alan’s expertise is a key resource for the industry, and he is a great addition to the EPiC team.

Richard Andrew, EPiC Managing 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 Alan Moon 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 enquiries@epic-auditors.com

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

If you need our help and support then please contact us on +44 (0)1244 980544 or e mail us at enquiries@epic-auditors.com

Lewis Corbett joins EPiC as Business Manager & Senior Consultant

EPIC Auditors are delighted to announce that Ex MHRA Inspector 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 from an Ex MHRA Inspector then please contact us on +44 (0)1244 980544 or e mail us at enquiries@epic-auditors.com

Another ex MHRA Inspector Joins the EPiC Team

EPIC Auditors is very pleased to announce that Ex MHRA Inspector Michelle Yeomans will be joining us on 7^th April to fulfil the role of EPIC Auditors Operations Manager. 

EPIC Auditors was established in 2014 by Liz Allanson and Darren Jones (both ex MHRA) to fulfil the increasing need for ex MHRA Inspectors to conduct mock regulatory inspections and to provide consultancy advice from the Regulatory perspective. The company has developed considerably over the last 8 years and Michelle has been appointed to further strengthen the management team and assist with the day to day operation of the business.

Michelle is well known to the pharmaceutical industry having been in the MHRA GMP/GDP management team for many years and been a familiar face at many MHRA GMP/GDP and GCP Symposia.  Michelle has completed 17 years in the MHRA starting as a GCP Inspector, progressing to Senior Inspector and gaining accreditation for GMP inspections of manufacturers of clinical trials, before moving to become a GMDP Operations Manager and ultimately the GMDP Inspectorate Unit Manager.

Michelle brings to EPiC not only the considerable length of service in the MHRA, at both Senior Inspector and senior management level, but also excellent organisational skills, and 19 years previous experience working and auditing in the pharmaceutical industry.  Michelle held positions in Technical and QA roles with various pharmaceutical companies and operated as an IMP Transitional QP prior to joining the MHRA.

Over the years Michelle has engaged extensively with the industry and we are sure this will continue as she works with our clients to help them to improve their GXP quality systems and regulatory compliance.

We are really excited about Michelle joining our team, and acknowledge the skills that she will bring to improving our own quality systems as well as those of our clients.

You can read more about Michelle’s background and qualifications as well as meet the rest of the EPiC Auditors Team here: Meet The Team

If you need our help and support then please don’t hesitate to contact us.

Telephone: +44 (0)1244 980544 or email us at enquiries@epic-auditors.com