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Curriculum Vitae : PETER SMITH CChem, MRSC, MInst. Pkg, MIQA

Summary

  • Graduate Chemist, Eligible to act as a Qualified Person
  • Extensive Production and Quality Assurance experience
  • Ex UK Government (MHRA) Medicines Inspector
  • Specialist knowledge of packaging and medicines legislation
  • International training and consultancy experience

Overview 

Peter is a chemist by training with supplementary training in applied microbiology and management/financial accounting.

He has extensive and varied pharmaceutical manufacturing and QA experience commencing in production supervision, moving on to senior management positions before becoming Factory manager for a leading UK contract pharmaceutical packaging company. Peter has also performed the role of the Qualified Person and is eligible to act in this role.

Following his 14 years of industrial experience (in Production and QA roles), Peter became a specialist Principle Medicines Inspector with the UK Medicines Inspectorate, with responsibility for non-sterile processing and packaging of pharmaceuticals.

In 1989 Peter joined a major UK Training and Consultancy Company, where he has provided Training and Consultancy/Audit services, specialising in UK, EU and US Regulatory and GMP/QA issues as well as Pharmaceutical Packaging, Processing, Statistics and Management Systems.

Peter enjoys being with his family (wife, two daughters, two dogs), photography, walking, restoring old motor cars (current project: Morris Minor convertible), visiting the theatre and watching the occasional football match at Leeds United.

Curriculum Vitae : Dr TERRY SNAPE BA, PhD, CChem, MRSC

Summary

  • PhD in non-Clinical Medicine (First degree in Chemistry)
  • Thirty years senior technical management experience in Blood Products
  • In depth experience of Aseptic Processing and Terminal Sterilsation Processing
  • Wide experience/membership of regulatory agencies (BP, Ph Eur 6B, CSM, MSBT, SACTTI)
  • EU Qualified Person, with 20 years experience acting in this role
  • International training and consultancy experience

Overview  

Terry has thirty years senior technical management experience (development/pilot-plant, production, factory management, QC, QA and RA) in the manufacture of fractionated plasma products, including the commissioning and operation of a major manufacturing unit. He also has in depth experience of the manufacture and quality control of large and small volume injectables prepared by aseptic processing and terminal sterilisation.

He has provided scientific, technical and regulatory advice to a range of commercial and publicly-funded organisations, including UK, Irish and New Zealand Blood Services, World Health Organization (WHO) and World Federation of Haemophilia (WFH). Assignments in the public sector have included expert reports (including expert witness) in the areas of HCV and HIV virus transmissions by blood and plasma products, and the potential for transmission of variant Creutzfeldt-Jakob disease (vCJD).

Assignments to the private sector have taken the form of training, audit and technical consultancy to a range of biotech companies manufacturing monoclonal antibody and recombinant preparations for clinical trial.

Terry’s experience of regulatory and control agencies has been gained through membership of a number of bodies including:

  • British Pharmacopoeia Committee H (Biologicals)
  • European Pharmacopoeia Group 6B (Blood Products).
  • Biologicals subcommittee of the Committee on Safety of Medicines
  • Advisory committee, Microbiological Safety of Blood and Tissues (MSBT)
  • Advisory committee, Transfusion Transmitted Infection (SACTTI).

Terry is named in the Royal Society of Chemistry’s register of persons eligible to function as a Qualified Person (QP); more than 20 years experience as an active QP.

Terry enjoys reading, working in his garden, traveling including walking holidays with his family.