Alan Moon

Senior Consultant, GxPAssure

Alan Moon is a former MHRA Lead Senior GMP Inspector, with a pharmaceutical career spanning industry, regulation and consultancy since 1994.  He served as the Inspectorate’s technical lead for sterile products and investigational medicinal products (IMPs).  Alan holds a BSc (Hons) in Applied Biological Sciences and is a Chartered Biologist and Member of the Royal Society of Biology (CBiol MRSB).

Before joining the MHRA, Alan spent approximately 19 years in pharmaceutical manufacturing and quality roles at Hoechst Marion Roussel, Patheon and Almac Clinical Services. His experience covers quality assurance, microbiological quality control, production, sterility assurance and validation. At the MHRA, he conducted approximately 200 inspections nationally and internationally, including on behalf of the EMA, and contributed to GMP guidance and inspector training.

Key areas of expertise

• Provides GMP regulatory oversight informed by extensive UK and international inspection experience across sterile, non-sterile, investigational and unlicensed medicines.
• Brings detailed knowledge of EU and PIC/S GMP Annex 1 as the principal UK representative on its revision working group.
• Offers expertise in IMP manufacture, clinical trial supply chains and import oversight, including contributions to Annex 13 and UK guidance.
• Supports sterility assurance through experience in aseptic processing, terminal sterilisation, lyophilisation and aseptic process simulation design.
• Provides technical expertise in equipment and process validation, requalification, sterilisation cycle development and cleanroom qualification.
• Combines microbiological QC experience with knowledge of environmental monitoring, water systems, endotoxin testing and cleanroom contamination control.
• Brings practical QA experience in deviation investigations, batch documentation review, quality agreements, supplier audits and inspection hosting.