Tracy Moore is an accomplished quality professional with over 32 years experience of pharmaceutical manufacture, distribution and regulation gained from working within the industry and also for the GMP Inspectorate of the UK medicines regulator (MHRA) where she reached Expert Inspector level. During her 10 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, most recently within her Expert GMDP inspector capacity was the principal MHRA GMP advisor for the COVID-19 pandemic vaccine supply chain, advising on regulation of QP certification and deployment of the vaccines alongside supporting the drafting of the GMP Annex 1 update, including presenting on this topic at PIC/S and other global events. Other highlights include being the MHRA Data Integrity GXP lead, the MHRA FMD GMP lead, EU GMP Annex 16, Annex 21, Annex 1, Chapter 4 and Annex 11 drafting group member, PIC/S representation both on sub-committees and chairing working groups.
Prior to joining the MHRA Inspectorate Tracy spent 22 years working in both commercial and R&D environments of the pharmaceutical industry in various QA, QP and management roles for a range of sterile and non-sterile products dosage forms. In addition to this, she has been responsible for the audit and oversight of Contract Development and Manufacturing Organisations (CDMO), component suppliers, and API manufacturers.
Honours Degree in Chemistry
Member of the Royal Society of Chemistry
Eligible to act as a Qualified Person