The Committee

Treasurer - Phil Butson

Phil is a pharmacist with a BPharm from the University of Bath and an MSc in Pharmaceutical Technology from King's College, London.

Due to mergers, Phil is currently working for his third pharmaceutical company (GlaxoSmithKline), without ever having left the first one he joined (Wellcome)!

Phil spent 18 months in formulation development and then had 3 years supervising the packaging and labeling of clinical trial supplies before moving to his first QA role in 1993.  He has experience of QA for both packaging and manufacture in both R&D and commercial environments.  He is eligible as a Qualified Person under the permanent provisions of 75/319/EEC.

His current position is Quality Assurance Manager, Pharmaceutical Development Quality Assurance with GlaxoSmithKline Research & Development at Harlow.

Phil joined PQG in 1998 and gained MIQA in 1999.  He was the co-ordinating co-author for the revision of the PQG monograph on Pharmaceutical Auditing during 1999/2000 and was elected to the PQG Committee in March 2001.  He took over as Treasurer from Graham Davison in 2003.  He provided active input to PS9001 and PS9100 and has run various meetings for the Group.  In addition to his activities for the PQG, he is a member of BARQA and has been a speaker at various professional meetings on the Quality Assurance of Investigational Medicinal Products and the Clinical Trials Directive (2001/20/EC).

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Committee Member - Helen Chattaway

Helen works at Pfizer.

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Responsible for Trainee QP activities - Samantha (Sam) Clack

Sam joined PQG in 2002 and was elected to the Committee in March 2008.

She graduated from the University of Reading in 1993 with an Honours Degree in Microbiology and Biochemistry. She started her career with Patheon Ltd (formerly Hoechst Marion Roussel) in Swindon, where she worked in technical and managerial roles in manufacturing and packaging. Over the five year period that she spent with Patheon she gained experience in a wide range of dosage forms including sterile powder filling, sterile and non-sterile ointment filling, creams, liquids and suppository manufacture and filling, tabletting and packaging.

Sam joined Eli Lilly & Company Limited in 2000 as a Senior Quality Assurance Associate working within the Corporate Quality Assurance division based in Windlesham, Surrey. Her responsibilities included auditing Lilly's Third Party Contractors and suppliers and providing training for Lilly affiliates worldwide. After four years she transferred to the Quality Operations Department at Lilly's UK manufacturing facility based in Basingstoke where solid dosage forms were manufactured and packaged.

Sam qualified as a QP in May 2005 and now works as a Team Leader within the Quality Operations division as well as being an active QP. Samantha joined the Pharmaceutical Quality Group in 2002 where she was actively involved in organising and helping out with several Trainee QP meetings. In 2008 she was co-opted onto the committee to take over the organisation and administration of the Trainee QP activities.

Samantha has two Post Graduate Diplomas in Business Management and Industrial Pharmaceutical Studies and is an ISO Lead Auditor.

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Committee Member - Jane Smith

Jane joined the PQG in 1991 and became a Committee Member in 2008. She works for GSK at Crawley.

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Secretary - John Lees

John is Director and Principal Consultant of Lees-Gilbert International Limited and LGI Group Limited with experience since 1996 in the management of computer systems validation.

John has held several senior level Quality Management roles in the design and manufacture of computer systems, automotive, SCADA systems, and telecommunications. He is familiar with ISO 9001, TQM and continuous improvement.

With many years experience in Quality Management, John brings a wealth of diverse experience to the PQG, together with experience in marketing and presentation. John is an MCQI, MIET and a Chartered Engineer.

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Chairman - Ashley McCraight

Ashley obtained his first degree in Chemistry from Birmingham University following which he then joined Glaxo Laboratories where he occupied numerous roles in Quality Control at Greenford (London) and Barnard Castle.

Enticed into the Foods Division of the business as a development analyst, he returned to Greenford to work with the development team, based there and in Slough. During this time he studied part time for the Mastership in Chemical Analysis at Southbank University supplemented by practical experience at Public Analyst's laboratories in London and Exeter.

After a period as Quality Control Manager in GlaxoFarley Food's cereals and rusks factory in Plymouth, he moved to back into pharmaceuticals at Liverpool. A series of roles in most areas of QA, Manufacturing and Purchasing led to the role of Company QA Manager for Glaxo Pharmaceuticals which he held for five years.

A long term interest in the importance of suppliers to the industry, catalysed during his management of the Glaxo supplier development programme, led onto his involvement and eventual leadership of the 'Partners' project.

The 'Partners' Team has developed the supplier GMP application standards PS 9000 and PS 9100 for packaging and excipient materials and PS 9004, a guide to PS 9000.

Having left GlaxoWellcome in 1997 he has developed a business offering consultancy in Quality Management and in partnership with Andrew Coulter, a supplier evaluation service to the industry.

Ashley became Chairman of PQG April 2007.

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Vice Chairman - David Mogg

David is a Chemist and studied at the University of Kent for his first degree and then gained an MSc from Sussex University. He started his working life in 1969 at May & Baker as a Production Manager in charge of various bulk chemical manufacturing plants then moved on to Baxter Travenol again in Production Management. After several years looking after LVPs, blood bags and extra corporeal support systems it was time again not only to move jobs but also to move south.

A couple of years as Quality Assurance Manager at Pall Filtration were followed in 1982 by five years as a Medicines Inspector with the United Kingdom Medicines Control Agency.

1987 saw him move back into industry as Technical Director for Laleham Healthcare where 11 years were enjoyed working in the contract manufacture and assembly of everything from heart tablets to body scrubs!

In 1998 together with a couple of colleagues he set up his own pharmaceutical consultancy business, QA Associates. The business continues to thrive and he now enjoys working as a consultant and QP for several pharmaceutical companies, not only releasing product but also helping them with systems and documentation to meet the needs of their businesses.

He has been a member of the PQG since its start and was Chairman from 2004 to 2007. He is also a member of the Pharmaceutical Packaging Forum, the Institute of Quality Assurance and the Royal Society of Chemistry. He is also involved with the QP course at Brighton.

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Committee Member - Diane Morris

Di started her career as a microbiologist whilst studying for a chemistry degree. Most of her career has been within the pharmaceutical industry, however she did work within the food industry for a number of years.

Di has worked as an analyst within both microbiological and chemical laboratories, eventually moving into Quality Assurance and Validation and has experience in most dosage forms including parenterals - liquid and freeze-dried traditional and vaccines, solid dose, liquids, gels and ointments.

A member of the RSC, DI has been a QP since May 1993 after completing a Post Graduate Diploma at Brighton and has been a member of the PQG for coming up to three years.

Within the companies that she has worked for she has been actively involved in chairing internal Standards Committees and currently chairs 'a QP Forum' which discusses internal and external processes to ensure where possible current practices are reviewed and if required adopted.

Her special interest currently is to provide a Quality Manual for the running of the group, its activities and those of the Committee.

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Leader of PS Series standards (Partners) Project - Steve Moss

Steve has had a long term interest in the importance of suppliers to the industry, catalysed during his management of the Glaxo supplier development programme, led onto his involvement and eventual leadership of the 'Partners' project.

He leads the 'Partners' Team that has developed the supplier GMP application standards PS 9000 and PS 9100 for packaging and excipient materials and PS 9004, a guide to PS 9000.

Over the past 14 years Steve has had several different QA roles with GSK companies auditing and providing support for contractors for new products, service contractors and material suppliers. He previously worked in the chemical industry in development, manufacturing and project management. His current role with GSK is to provide QA input to projects in the Strategy & Global Logistics function. Projects range from supply chain temperature compliance through to new software for artwork development and control or serialisation. Also lead author for related Quality Management System policies and processes.

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Committee Member - Colin Newbould

Colin is an Analytical Chemist with a first class BSc from the University of Kingston-upon-Hull.

Colin gained practical experience in the area of API’s whilst working in R&D, analytical development, and the manufacture of high purity lipids and oils at Croda Chemicals. Colin was part of the team responsible for the pilot plant manufacture of Lozenzo’s oil and other key functional lipids.

Colin currently works within a small pharmaceutical company in the area of solid oral dosages. His current position is Quality Control, Quality Assurance and Laboratory Manager, (as well as taking on the R&D role), within Essential Nutrition Limited based in Brough East Yorkshire. The company specialises in the manufacture of herbal medicines, “specials” and clinical trial supplies. Essential Nutrition has strong links with the BPC committee G section and is currently working with the BP Laboratories on aspects of herbal medicine identification and assay in accordance with 2004/24/EC.

Colin joined PQG in 2002 and was elected to the Committee in March 2005

Colin is eligible to act as a Qualified Person under permanent provisions.

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Webmaster & Committee Member - Norman Randall

Norman is a Chemist and studied at Brighton Polytechnic for his first degree and later obtained his PhD by part-time study. He has worked in the pharmaceutical industry all of his life, starting with Beecham Research Laboratories in the R&D and QA laboratories.

Subsequently, he moved to Berk Pharmaceuticals, Rorer Pharmaceuticals, and then in 1990 to Rhône-Poulenc Rorer UK as Director of Quality at the Dagenham manufacturing plant. From 1995 to June 2000, he worked in the RPR corporate quality group in Paris, as Director of Supplier Assurance. In this role he was responsible for co-ordinating world-wide quality audit and other activities for suppliers to RPR; this included monitoring the potential effects of BSE on products made and bought by RPR.

The merger of RPR and HMR to form Aventis Pharma in 1999 gave him the opportunity to return to the UK and in July 2000, he set up his own pharmaceutical consultancy business. He now works with pharmaceutical companies on QA systems, Supplier Assurance and auditing.

He served on the British Pharmacopoeia Commission until 2005 and was on two of the expert Committees

Norman has been a member of the PQG for many years. He served as Chairman from 2001 to 2004. He was one of the three PQG members who set up the York Training Course and acted as a course Supervisor for 5 years and a lecturer for 14 years. He has been an active contributor to monographs, the PS series standards and more recently, the new IPEC/PQG Excipients GMP Guide. He has a strong interest in working with Qualified Persons and their training and for the PQG, he runs the annual MHRA discussion meeting.

He now maintains the web site so if you find any broken links, errors, or have any suggestions for the site please e-mail him on .

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Committee Member - David Sanson

David commenced his career in the National Health Service in 1978 specialising in Histopathology, before moving into contract research with Huntingdon Life Sciences in 1984.

David joined what was then Sterling Winthrop (now Sanofi-Aventis) in 1985 and for over 17 years had various roles within Toxicology and Quality Assurance, latterly as Head of Quality, with responsibility for Good Manufacturing and Good Laboratory Practice compliance for the UK, Research and Development site.

During this time David gained experience in the manufacture of sterile products, and tablet and capsule manufacture for clinical trials, as well as Toxicology studies in a variety of animal models. David was also involved in the implementation of the ISO9001 quality standard and the ISO14001 environmental standard and is an ISO9001 lead auditor and a ISO14001 internal auditor.

David joined Angel Biotechnology in March 2003 as Quality Manager and was responsible for the implementation of the Quality Management System meeting the requirements of 2001/20/EC for the manufacture of biological clinical investigational products, and successfully obtained MHRA accreditation in June 2005. David also gained Qualified Person status under the transitional route.

David moved to Avecia Biotechnology in August 2005 as Quality Systems and Compliance Manager for the vaccines business, where he is responsible for the maintenance and improvement of the Quality Management System.

David has a BSc Life Sciences from Napier University, Edinburgh and an MSc Quality Management from the University of Sunderland Business School.

He is a Member of the Institute of Biology (CBiol, MIBiol), Fellow of the Institute of Quality Assurance (FIQA) and Fellow of Research Quality Assurance (FRQA).

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Membership Secretary - John Wilson

John began his career in the pharmaceutical industry in 1973, being employed as Microbiology Section Leader at Upjohn's Crawley facility. During his ten years at Upjohn he moved from the laboratory to take up a QA appointment and at that time was named on the company's product license, and under the transition arrangements subsequently became a Qualified Person.

From Upjohn he spent two years as QA manager for a contact lens solution manufacturer before moving into pharmaceutical consultancy with PED, a forerunner of Bovis Tanvec. Whilst having a consultancy role he established the validation department (mid 1980s) when GMP compliance and validation were becoming key issues for the pharmaceutical industry.

After eight years he moved into Engineering Contracting where he has specialised in GMP consultancy and validation activities for John Brown (now Kvaerner Process), Raytheon (now Washington Group International) and Jacobs Engineering.

He is currently acting as a freelance consultant and interim on validation and engineering matters.

John is a Chartered Microbiologist. He has been a member of the PQG since the late 1980s and acts as the Membership Secretary, a position created in response to the continued growth of the group.

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