Beyond the Basics:
Mastering GMDP Compliance
and Inspection Readiness

Richard Andrews is an accomplished quality professional with over 35 years' experience working within Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) environments both in industry and for the UK medicines regulator (MHRA) where most recently as an Inspectorate Unit Manager he had overall responsibility for the GMP and GDP Inspectorates. Richard’s 18 years' experience at the MHRA spanned the licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities.

Prior to joining the MHRA Richard worked in the pharmaceutical industry for 17 years focusing mainly on the manufacture of bulk active pharmaceutical ingredients (API), gaining experience of process development and technical support and holding managerial positions in both Quality Assurance and Production.

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Darren Jones is an independent pharmaceutical consultant with experience in sterile, aseptic and non-sterile (liquid and solid) dosage form manufacturing operations for both commercial and clinical trial use. He worked for 4 years as a GMP Inspector for the MHRA being responsible for the inspection of manufacturing, testing and distribution sites in the UK and around the world. He has presented lectures to the PHSS and at the MHRA GMP symposium.

Prior to joining the MHRA Inspectorate Darren spent 18 years at AstraZeneca in various QA, QP and management roles. He also spent some years working in API manufacture and has expertise in quality management systems and preparing sites for EU regulatory inspection

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Michelle Yeomans is an accomplished quality professional with over 36 years’ experience working within Good Manufacturing (GMP), Good Clinical Practice (GCP) and Good Distribution Practice (GDP) environments both in industry and for the UK medicines regulator (MHRA).

During her 17 years at the MHRA Michelle contributed to the development of a national programme for GCP statutory inspections and the development of EMA GCP inspection procedures, the development of regulations and European guidelines relating to GMP for investigational medicine products (IMPs), and management oversight of the licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas as Inspectorate GMDP Operations Manager and Unit Manager.

Prior to joining the MHRA, Michelle spent 19 years working in the pharmaceutical industry, with experience of a variety of finished product dosage forms and clinical trial development. Her previous roles have included technical development and quality management roles, developing quality systems in manufacturing and laboratory environments for pharmaceutical and healthcare products. Michelle also has experience of leading quality management activities within a contract research environment including IMP manufacture and the conduct of clinical trials. She is recognised as a transitional Qualified Person for IMPs.

Lewis Corbett is an accomplished quality professional with 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.

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Philip Rose is an independent pharmaceutical consultant with over 20 years’ experience within the pharmaceutical industry, from QC through to senior management and as a Qualified Person. Most recently, he worked as a Lead Senior GMDP Inspector for the UK competent authority the MHRA. Within this role, he inspected some of the most complex cases globally against EU GMP and GDP in areas such as biologicals (including vaccines), steriles, non-steriles, ATMPs and specials. This included inspections on behalf of the EMA as well as leading joint inspections with the U.S. FDA.

Philip was a member of the MHRA’s Compliance Management Team (CMT) and was the Inspectorate technical lead for biologicals and, previously, the technical lead for steriles. He was also a member of the Inspectorate’s cross-contamination group. Philip recently served as a key member of the MHRA’s Vaccine Task Force involved in the UK’s COVID-19 response.

Philip has wide-ranging skills across many dosage forms, including global auditing and inspection readiness. He is fully conversant with current regulations and is able to bring a wealth of experience from working as a regulatory inspector, including as a member of the Compliance Management Team, in addition to time spent within the industry and is very able to find solutions to complex situations and has an in depth and current knowledge of regulatory guidance and the interpretation of it.

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Tony Orme is an independent pharmaceutical consultant with over 32 years’ experience at MHRA in various areas of the regulation of pharmaceutical distribution. 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.

He was the GDP EU Exit Lead and provided the guidance for import, the RPi 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.

Tony was also 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.

https://epic-auditors.com/meet-our-experts-gxp-regulatory-inspectors/

Ian Rees is an independent pharmaceutical consultant with over 40 years’ experience in the industry. During his 22 years at the MHRA, in addition to being a GMDP Inspector Ian was the Unit Manager for the Inspectorate Strategy and Innovation team and helped establish the Innovation Office. Ian also 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. Ian was a GMP inspector at VMD for 2 years prior to joining MHRA.

During his time in industry, Ian helped establish a startup biologic company, became its Operations Manager and through to inspection and authorisation by MCA, MHRA’s precursor organisation.

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.