Liz Allanson is an independent pharmaceutical consultant who previously worked as a GMP Inspector in the MHRA Inspectorate for 18 years, culminating in the position of Manager of the GMP Inspection Unit. Throughout her time in the UK Inspectorate she performed countless GMP/GDP inspections, of all major dosage forms, in the UK and worldwide. As a result Liz has significant knowledge of current regulatory and GMP requirements in Europe, including the requirements for Investigational Medicinal Products and previously lectured on these subjects at QP training courses.

She is a pharmacist by profession and prior to joining the Inspectorate in 1986 was a Quality Assurance pharmacist in the UK National Health Service, responsible for managing the QA department connected to a large volume sterile manufacturing unit. Liz has particular expertise in quality management systems.

Qualifications

Honours degree in Pharmacy from John Moores University, Liverpool.

Liz is registered as a Lead Auditor with IRCA and is eligible as a Qualified Person under EC Directive 2001/83/EC.

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

Qualifications

Honours Degree in Applied Biology

Member of the Society of Biology

Eligible to act as a Qualified Person

IRCA Principal Auditor

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.

Qualifications

Masters Degree in Quality Management and Improvement

Studied BSc in Applied Chemistry

BTEC HNC in Chemistry

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. 

Qualifications

Masters Degree-Quality Management and Improvement

Post Graduate Diploma-Business Process Improvement and Quality Management

BTEC HNC-Pharmaceutical Science

BTEC ONC-Chemistry

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.

Qualifications

BSc. Hon. Industrial and Environmental Chemistry

Qualified Person training and eligibility assessment by Joint Professional Bodies

NEBOSH General Certificate in Occupational Safety and Health

Stephen Grayson is an independent pharmaceutical consultant with over 39 year’s experience in pharmaceutical manufacturing, packaging, auditing and inspection gained through working within the industry and as an MHRA inspector for 14 years; most recently as a Senior GMDP Inspector.

Stephen was trained and accredited by the MHRA to inspect: Collection, processing, testing and distribution of blood and blood components, Sterile and non-Sterile manufacturing sites (all dosage forms), NHS and commercial “Specials” manufacture, including sterile product, Sterilisation processes including irradiation, ethylene oxide, moist heat and dry heat, Sterile API manufacture, Wholesale dealers (storage and distribution).

Widely known across the industry Stephen has extensive experience of GMP inspections having completed more than 500 in the UK and over 300 in third countries. Stephen has also conducted regulatory inspections and commercial corporate level audits of biological product manufacture, contract manufacturers, contract laboratories and suppliers.

Qualifications

MSc Bioprocessing

M.Inst.Pack (Dip)

BSc Biological Sciences

Richard Funnell is an independent pharmaceutical consultant with over 30 years experience in both the industry and the regulatory sector. He is an expert at performing GMP audits worldwide.  He worked within the MHRA GMP inspectorate from 2003 until 2014, including seven years as a senior inspector when he was the lead for investigational medicinal products (IMP) Good Manufacturing Practices (GMPs).

He is able to audit biologicals sites as well as traditional pharmaceutical operations; drug substance and drug product manufacturers.

He has a  industry background in the production and QA of sterile products, tablets and oral liquids.

Qualifications

Degree in Chemistry at the University of Oxford in 1985

Qualified QP since 2002

John Clarke has over 35 years’ experience in pharmaceutical manufacturing with experience in sterile liquids/powders, solid dose, metered dose inhalers, powder inhalers, creams/ointments, oral liquids, sterile APIs. Trained by the MHRA, he is an expert at performing GMP inspections/audits across a wide variety of organisations in the UK and overseas. He worked for the MHRA as a GMP Inspector from 2001 to 2017 with 14 years as a senior inspector with wide experience in auditing including sterile & non-sterile manufacturers, contract laboratories, Gamma irradiation sites,  sterile API manufacturers, parallel importers and storage and distribution sites.  He has a background in Quality Assurance and Compliance of sterile and non-sterile products with a variety of roles working as QA  Manager, Lab Manager and Compliance Audit Manager. He is also eligible to work as an EU QP.

Qualifications

Honours Degree in Biochemistry

Eligible EU Qualified Person

EU Expert  GMP/GDP Inspector

Ian Ramsay is an independent pharmaceutical consultant with experience in the industry and as an MHRA inspector.  He worked as a GMP and GDP inspector for the MHRA from 2012 to 2016 leading over 100 inspections worldwide with emphasis on third countries. He has experience in a range of dose forms (non-sterile, sterile, biologic, ATMP and unlicensed).

He contributed to the MHRA strategy on Data Integrity. Trained as key subject matter expert in Data Integrity and inputted on the MHRA guidance and approach.

He has significant experience in Quality Assurance and compliance.

He is LMLS Green Belt accredited and able to offer pragmatic, risk-based and efficient solutions to real-life quality and compliance issues.

Qualifications

Degree in Biology

Member of the Royal Society of Biology

Ian Harwood is an independent pharmaceutical consultant with over 35 years experience of pharmaceutical manufacturing and GMP regulatory inspections.  He has extensive experience in a wide range of pharmaceutical dosage forms and manufacturing processes including Terminal Sterilization and Aseptic manufacture (both large and small scale), lyophilization, biologicals and non-sterile manufacture of tablets, capsules creams and ointments. 

As a Senior Inspector at the MHRA Ian was the lead for Unlicensed medicines.  As part of this role he represented the Agency at industry and NHS groups including the NHS QA Committee and UK Radiopharmaceutical Group. He also gained significant experience of working with companies with complex compliance issues that had been referred to the Inspection Action Group and Compliance Management Teams.   

Ian also has significant experience of Senior QA management roles, including 14 years as a Qualified Person, gained in various pharmaceutical companies ranging from large multinational companies to small startups. 

Qualifications
BSc Hons Microbiology – Liverpool University (1985)

PGDip Industrial Pharmaceutical Science – University of Brighton (1996)

Eligible for Nomination as a Qualified Person under Permanent Provisions of EC Directive
2001/83 (2000)

Kath Williams is a highly experienced Quality Assurance consultant and a former MHRA GCP Senior Inspector. Kath has over 20 years experience working in the pharmaceutical and regulatory environment, including auditing in GCP (extensive), GPV  and clinical / analytical laboratory areas as well as for-cause and due diligence audits. In addition, she has worked at a strategic level in developing risk based strategies for QA led initiatives and audit programmes as well as departmental and line management responsibilities. As well as working in the Regulatory environment as a former MHRA GCP Senior Inspector Kath has additional experience of working for small, medium and large pharmaceutical companies in a QA environment.

Qualifications

PhD in Analytical Chemistry

MSc in Analytical Sciences

Graduate of the Royal Society of Chemistry Part II (Class I)

HND in Physical Sciences (Chemistry)

Chartered Chemist (CChem) and Member of the Royal Society of Chemistry

RQA member since 2002

RQA Board Member and Chair Elect ( since November 2017)

Louise is an independent auditor and trainer with over 25 years experience working in the industry in GMP, GLP, GVP and GCP environments.  Louise worked within the MHRA GCP Inspectorate for 7 years with 5 years experience as a Senior Inspector in GCP and as an accredited GLP Inspector.   She has significant experience in Quality Assurance and Quality Management Systems and has performed numerous QMS audits, data and study audits (including reports), supporting systems including CSV and e-data considerations, bio-analytical and safety laboratories.

Louise also has experience in performing audits of Affilliates, PV Systems, Pharmacovigilance System Master File (PSMF), Marketing Partners and Service Vendors.

Qualifications

Post Graduate Diploma in Research Quality Assurance

BSc Honours, Upper Second Class (Associated with Biology)

BTEC HND Science (Medicinal & Cosmetic Products)

Member of The Research Quality Association (formerly the British Association of Research Quality Assurance, BARQA), and current Board Member for Strategy

Mark started his career in Pharmaceutical Discovery Research where he spent 17 years in a number of anti-infective programmes.  Mark then moved into Clinical Research where he worked as a global Programme Manager working for a number of different pharmaceutical companies (British, French, American and Japanese) and has managed different trials in many therapeutic areas on a global basis.  In this time Mark was involved in all aspects of research from drug development planning, management and reporting of trials and submitting trial data to authorities.

After 13 years in clinical research Mark moved to the MHRA, where he was a GCP Inspector and was involved in all aspects of GCP inspection in the UK and overseas.  He was involved in the non-Commercial inspection process and also the bioequivalence inspection process.  After 5 years as an inspector, Mark joined ADAMAS Consulting in October 2011 where he was involved in a number of different audit types in different areas of the world, having performed most aspects of GCP, laboratory aspects of GLP and IMP manufacturing aspects of GMP audits.  In 2017, Mark moved back into the pharma industry by taking on the Senior Manager QA role at Clovis Oncology and in 2019 set up his own quality consultancy company Poulton Quality Solutions Ltd to provide global quality expertise and advice to clients to ensure compliance and understanding of clinical requirements.

He has vast experience, not only in clinical trial management but also in clinical quality compliance and training. He has conducted in excess of 350 audits / inspections of clinical trials and systems and has performed in excess of 20 training courses covering most aspects of clinical trial quality and compliance.

Qualifications

Mark has a degree in Applied Biology, specialising in Microbiology and is a member of Research Quality Assurance (RQA).

Claire Glenister is an independent GDP pharmaceutical consultant with over 22 years’ experience in both the industry and regulatory sector, most recently as a GDP Inspector and Operations Manager for the MHRA. 

Through her experience with the MHRA, she has an excellent understanding of how the EU GDP Guidelines should be applied to a company’s operations and is an expert at performing audits / inspections across the full portfolio of UK Wholesalers and their respective business models.

Prior to joining the MHRA Claire worked in a variety of roles for a global pharmaceutical manufacturer.  These roles included Quality Manager for both manufacturing and non-manufacturing areas of the business and, latterly, as the site compliance auditor which involved undertaking regular audits of all areas related to the manufacturing and testing of respiratory and oral solid dose products.

Qualifications

Honours Degree in Business Administration

Peter is an independent GDP pharmaceutical consultant with over 18 years’ experience of inspecting companies for compliance with EU GDP for the MHRA, initially as a GDP Inspector and, since 2011, as an Operations Manager and a Senior Inspector. He has led numerous highly complex GDP inspections across the UK and has extensive knowledge of UK and Global supply chain management and the transportation requirements relating to GDP.

Before joining the Inspectorate, Peter worked in other key MHRA roles including Prosecutions Manager where he became extremely experienced in the complexities of medicines law and the variety and potential seriousness of violations.

Before joining the MHRA Peter gained extensive experience in building design, engineering and management which lends itself perfectly to being able to advise on the correct facilities for the compliant storage of pharmaceutical products in line with GDP regulations.

Gaynor is a former MHRA Senior Good Distribution Practice (GDP) Inspector with over 24 years of experience, spanning the pharmaceutical wholesale sector and the UK medicines regulator.

While working in industry, Gaynor project managed the implementation of an automated ‘A’ Frame system, WHMS, warehouse build and audited to ensure GDP compliance.

Using her extensive knowledge of GDP, Regulatory Requirements, Quality Systems and Quality Risk Management, Gaynor worked extensively in the training and mentoring of MHRA GDP Inspectors.

Having worked both within the UK medicines regulator and in industry as a Project and Business Compliance Manager, Gaynor understands the pressures and complexities on WDA(H) & WDA(V) holders and the necessity to fulfil their legal obligation and comply with the regulatory requirements in protecting public health.

Gaynor has the experience, knowledge and understanding to make the journey to compliance and the protection of public health a more simplified and streamlined process for both RPs and Licence Holders.

Mariam is a qualified Pharmacist with 12 years’ experience in the UK Pharmacy sector and 9 years in pharmaceutical wholesale distribution, comprising of roles as WDA(H) licence holder, MHRA GDP Inspector and most recently, Senior Consultant and Trainer. The vast array of experience gained has been utilised in working with industry professionals and organisations to ensure the integrity of the medicines supply chain and ultimately, to protect public health.

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.

He 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.

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.

Philip Rose is an experienced quality professional and Qualified Person (QP) 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.

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