EPiC Auditors are thrilled to announce that Ian Rees, a renowned pharmaceutical compliance expert and former Expert MHRA GMDP Inspector, has joined our team as an independent consultant.

With an impressive career spanning over 40 years, twenty of which were with the MHRA, Ian brings a wealth of invaluable experience to our organisation. 

During his time at the MHRA, in addition to being a GMDP Inspector Ian was the Unit Manager for the Inspectorate Strategy and Innovation team, represented the Agency on the European Medicines Agency’s (EMA) GMDP Inspectors Working Group, was chair of the EMA/HMA’s Joint Audit Program (JAP) and was the MHRA representative at EU Blood Authority Meetings which regulates blood used for transfusion. 

In 2013 Ian helped to establish the MHRA’s Innovation Office and in 2014 the UK cross regulatory ‘One Stop Shop’ which provides regulatory advice and guidance to organisations developing innovative products or novel manufacturing processes.  

Prior to leaving the MHRA Ian became an assessor in the newly created Science Research and Innovation Group which incorporated the Innovation Office and was the MHRA’s representative at the Innovation Accelerator, a UK cross-industry regulatory group established to support innovations. He also led MHRA’s work in developing a new regulatory framework for distributed and point of care manufacture. 

A Vet by training Ian also has a background in veterinary medicines and was a GMP inspector at the UK’s Veterinary Medicines Directorate where he was also involved official batch release, scheduling of inspections and assessment of dossiers of immunological veterinary medicinal products. 

With his extensive expertise, Ian brings a comprehensive understanding of national and international regulatory processes, ATMPs, biologicals, and biotechnology manufacturing systems, as well as Quality Management System requirements. 

We are privileged to have Ian Rees join the EPiC team, enhancing our capabilities and expanding our consultancy services to support innovation. His exceptional track record and knowledge of the complex regulatory landscape will undoubtedly be of benefit to our clients

Richard Andrew, EPiC Managing Director & Senior Consultant  

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

Pharmaceutical Industry Experts  

At EPiC Auditors, our expertise lies in providing comprehensive pharmaceutical compliance auditing services, regulatory compliance guidance, and expert insights to pharmaceutical companies. As a leading auditing and GxP quality assurance consultancy firm, we specialise in ensuring that the highest quality standards are achieved and maintained within the pharmaceutical industry. Our seasoned team of former Regulatory Agency professionals are committed to our mission of ensuring 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

Cyber Essentials Accreditation

This month, Epic Auditors are proud to announce that they have achieved certification from Cyber Essentials proving their dedication to guard against cyber threats and demonstrate a commitment to cyber security.

What is Cyber Essentials?

Cyber Essentials is an official UK, Government backed scheme that encourages organisations, of all sizes to adopt best practice in information security and ensures they take sufficient measures to prevent against the risks of possible threats against a whole range of cyber attacks.

This certification is awarded by means of an independent assessment of the business security controls and processes, it also gives peace of mind that company defences will protect against the vast majority of common cyber-attacks. Receiving this accreditation shows that EPiC Auditors have addressed those basics to prevent the most common attacks within their systems.

Richard Andrews, Managing Director of EPiC Auditors commented “Achieving the Cyber Essentials certification is crucial in ensuring our cyber security is as strong as possible to protect our clients’ sensitive data. Our clients can have the confidence and trust that we are following best practice guidelines and recognise the importance of keeping their information safe and our IT systems secure.”

EPIC Auditors are dedicated to investing in its cyber security and will continue to adopt best practices in their information security strategy to ensure that the data we hold is managed properly and kept in a secure and safe digital environment.