Tracy Moore TM Pharma Group

Tracy Moore is an accomplished quality professional with over 35 years of experience in pharmaceutical manufacture, distribution and regulation gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector level/status. During her ten 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 was a drafting member of the MHRA EU PICS GMP Annex 1 document in addition to Annex 16 and Annex 21 and the MHRA GXP data Integrity lead, publishing the 2018 guidance document. Tracy set up the MHRA's inspector academy in 2020, which allowed for an efficient accreditation of MHRA inspectors and assessed Member States ' inspectors' competence through the Joint Audit Programme for EU. Before MHRA, Tracy spent 22 years working in the pharmaceutical industry's commercial and R&D environments in QA, EUQP and management roles covering sterile and non-sterile product dosage forms, including biologics and oral vaccines.