Extensive Pharmaceutical Industry Experience
Auditors used by EPIC are former Regulatory Inspectors; typically ex MHRA Inspectors and are eligible Qualified Persons. All auditors have extensive industry experience as well as many years’ experience auditing within the industry as Regulatory Inspectors. Each auditor has performed hundreds if not thousands of audits worldwide. Many are IRCA approved certificated Pharmaceutical Lead Auditors.
EPIC Auditors have extensive global experience auditing within Europe, the USA, Puerto Rico, India and China. Audits in all parts of the World will be considered.
Liz Allanson, BSc (Pharm) MRPharmS, Managing Director, Qualified Person
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.
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, BSc (Hons), CBiol, MRSB
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
Honours Degree in Applied Biology
Member of the Society of Biology
Eligible to act as a Qualified Person
IRCA Principal Auditor
Richard Andrews, MSc
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.
Masters Degree in Quality Management and Improvement
Studied BSc in Applied Chemistry
BTEC HNC in Chemistry
Michelle Yeomans, MSc
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.
Masters Degree-Quality Management and Improvement
Post Graduate Diploma-Business Process Improvement and Quality Management
BTEC HNC-Pharmaceutical Science
Tracy Moore, BSc (Hons), MRSC
Tracy Moore is an accomplished quality professional with over 32 years experience of pharmaceutical manufacture, distribution and regulation gained from working within the industry and also for the GMP Inspectorate of the UK medicines regulator (MHRA) where she reached Expert Inspector level. During her 10 years as a GMP Inspector Tracy had responsibility for 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.
Tracy, most recently within her Expert GMDP inspector capacity was the principal MHRA GMP advisor for the COVID-19 pandemic vaccine supply chain, advising on regulation of QP certification and deployment of the vaccines alongside supporting the drafting of the GMP Annex 1 update, including presenting on this topic at PIC/S and other global events. Other highlights include being the MHRA Data Integrity GXP lead, the MHRA FMD GMP lead, EU GMP Annex 16, Annex 21, Annex 1, Chapter 4 and Annex 11 drafting group member, PIC/S representation both on sub-committees and chairing working groups.
Prior to joining the MHRA Inspectorate Tracy spent 22 years working in both commercial and R&D environments of the pharmaceutical industry in various QA, QP and management roles for a range of sterile and non-sterile products dosage forms. In addition to this, she has been responsible for the audit and oversight of Contract Development and Manufacturing Organisations (CDMO), component suppliers, and API manufacturers.
Honours Degree in Chemistry
Member of the Royal Society of Chemistry
Eligible to act as a Qualified Person
Stephen Grayson, MSc
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.
BSc Biological Sciences
Richard Funnell, MA, MRSC
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.
Degree in Chemistry at the University of Oxford in 1985
Qualified QP since 2002
John Clarke, BSc (Hons) CCHEM, MRSC
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.
Honours Degree in Biochemistry
Eligible EU Qualified Person
EU Expert GMP/GDP Inspector
Ian Ramsay, BSc (Hons)
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.
Degree in Biology
Member of the Royal Society of Biology
Ian Harwood, BSc (Hons), MRSB
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.
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
Kathleen Williams, PhD, MSc, CChem, MRSC
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.
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 Mawer BSc (Hons), PgDip
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.
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
Madeleine Ault, MBA, PGCE, PGDip, BA(Hons)
Madeleine is an independent GDP pharmaceutical consultant with broad experience of the wholesale distribution supply chain. She worked for the MHRA as a GDP Inspector from 2009 to 2019, including four years as a Senior Inspector being responsible for the inspection of wholesale distribution sites across the UK, covering; full line, short line, grey market, Third Party Logistics, MA holder, transport/cargo handlers/freight agents, contract packers, marine and niche sectors.
She has contributed to the development of guidelines and explanatory documents, e.g. MHRA ‘Green Guide’, Inspectorate blogs and gov.uk website and presented regularly at the MHRA GDP Symposium.
As a qualified teacher Madeleine is experienced in developing and delivering training for the industry such as the Cogent approved Responsible Person Gold Standard course.
Prior to joining the MHRA Madeleine worked for the NHS for 12 years, first in Pharmacy Aseptic Manufacturing and Quality Assurance and then for the Blood and Transplant service.
Master of Business Administration: Project Management
Postgrad. Cert. in Education: Post-Compulsory Education & Training
Postgrad. Dip. in Business Project Management
Honours Degree in Environmental Technology and Management
Claire Glenister BA (Hons), PCQI
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.
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.