Tracy Moore TM Pharma Group Ltd

In her capacity as an Expert GMDP Inspector, Tracy played a pivotal role as the primary MHRA GMP advisor for the COVID-19 pandemic vaccine supply chain. Her expertise extended to providing guidance on the regulation of QP certification and overseeing the deployment of vaccines under Regulation 174. Tracy also contributed significantly to the pharmaceutical landscape by supporting the drafting of the GMP Annex 1 update, actively sharing insights on this matter at global events such as PIC/S. Among her notable achievements, Tracy served as the MHRA Data Integrity GXP lead and assumed the role of MHRA FMD GMP lead. Her involvement extended to being a key member of drafting groups for EU GMP Annex 16, Annex 21, Annex 1, Chapter 4, and Annex 11. Tracy represented MHRA on PIC/S subcommittees and took on leadership responsibilities by chairing working groups. Before joining the MHRA Inspectorate, Tracy amassed 22 years of experience in the pharmaceutical and Bio-Pharmaceutical industry. Her diverse roles encompassed QA, QP, and management positions in both commercial and R&D environments, covering a range of sterile and non-sterile product dosage forms. Tracy's responsibilities included conducting audits and overseeing Contract Development and Manufacturing Organisations (CDMO), component suppliers, and API manufacturers. With a decade of experience as a GMP Inspector and an additional three years as an Expert GMDP Inspector, Tracy has demonstrated a commitment to ensuring regulatory compliance and fostering collaboration with European and international regulatory authorities. Her multifaceted contributions extend to shaping and refining industry standards, making her a respected figure in the pharmaceutical regulatory landscape.