CBiol MRSB, Independent Pharmaceutical Consultant, former Head of Aseptic Strategy and Intelligence, GlaxoSmithKline.
- Responsible for setting and monitoring Quality standards for GSK’s Global Manufacture and
Supply pharmaceutical sterile manufacturing operations worldwide.
- Part of the team that rewrote sections of the FDA 2004 aseptic manufacturing cGMP guideline and the 2007 PQRI (FDA) white paper – Post Approval Changes to Sterile Products.
- Held a corporate governance and consultancy role supporting the GSK Vaccines manufacturing operations and Pharmaceutical Development (R&D). Awarded the honour of Senior Fellow GSK.
- Principal author and editor of PHSS’ Technical Monograph No.20 (Bio-contamination
characterisation, control, monitoring and deviation management in controlled / GMP classified
areas). The team that produced this monograph included representatives from the UK, French
and Irish regulatory authorities.
- Historical industrial involvement was through membership of Parenteral Drug Association (PDA) Aseptic Task Group and US Product Quality Research Institute (PQRI) Aseptic Task Group and
International Society for Pharmaceutical Engineering (ISPE) technical team.
- Former Board member of the British Chapter of the PDA.
- Contributing author for PDA Technical Report No1 – Validation of Moist Heat Sterilization
- Part of ISPE technical team involved with the development of Restricted Access Barrier Systems (RABS) definition published in the Pharmaceutical Engineer Nov 2005.
- Presented the EU industry position as European Federation of Pharmaceutical Industries and Associations (EFPIA) representative to the EU inspectorate EMEA meeting for the changes to the
EudraLex Vol 4 Annex 1 2008 update.
- He is a Chartered Biologist and Member of the Royal Society of Biology.
- Prior to working for GSK he was a Medical Laboratory Scientific Officer within the UK Public Health Laboratory Service (now the Health Protection Agency).
- External professional involvement includes membership of PHSS where he is an active member of the Biocontamination Control Interest Group.
- Won the George Skies memorial award in 2016 for the best paper of 2016 in European Journal of Parenteral & Pharmaceutical Sciences
CBiol MRSB former Director of Aseptic Strategy and Intelligence for GlaxoSmithKline and Principal author of GSK Sterile standards and PHSS Technical Monograph No.20.
- Has over 38 years’ experience within the pharmaceutical industry working for GSK and is
regarded as a world-leading expert in Sterile manufacturing and control.
- His advice and leadership have been sought internationally both within GSK and from external industry-leading organisations such as PHSS, ASCCA and PDA, with Mike presenting on subjects
as diverse as “Causes of Contamination within Aseptic Areas”, “EU Annex 1 Revision”, “False
Positive Sterility Test Causes”, “WHO Annex 6 requirements” and “Environmental Monitoring
- Within GSK as Director of Aseptic Strategy and Intelligence, he was the leading author and contributor to the Global Sterile Policy and Guidance documents for Sterile Manufacturing and
has conducted numerous Aseptic Manufacturing Reviews inspecting processing, controls and
engineering. Countries visited include USA, Canada, Mexico, Brazil, India, China, Saudi Arabia
- In 2014 he was one of the principal industry authors and editors of the leading cGMP text on aseptic manufacturing, “PHSS Bio-contamination Technical Monograph No.20”, whose review
body included MHRA.
- He also co-wrote the scientific paper for the evaluation and selection of suitable incubation temperatures for environmental monitoring which was awarded the prestigious George Sykes’
Memorial Award for best paper in the 2016 European Journal of Parenteral and Pharmaceutical
- Prior to his global role, Mike hosted many regulatory inspections, acting as Senior Sterile Products QP for over 15 years, and attended review sessions at regulatory headquarters in the US (FDA), UK (MHRA) and Europe (BGA).
- Since 2007, he has co-hosted and presented regularly at Global Aseptic Manufacturing
Workshops in London, Europe and Asia.
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