Address
1st & 2nd Floor 2 West Street, Ware, Hertfordshire, England, SG12 9EE
About the founder
Founded in 2022, by a former Expert MHRA GMP inspector, with more than 33 years of experience in Pharmaceutical development, manufacture, distribution and regulation.
An accomplished quality professional and EU QP
Tracy has over 33 years of experience in 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/status.
10 years as an MHRA, EU and WHO PQT 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.
Expertise
Tracy has expertise across most dosage forms, particularly sterile manufactured products produced aseptically, including supporting the drafting of the GMP Annex 1 update and presenting on this topic at PIC/S and other global regulatory events.
About Tracy
Within her role as Expert GMDP Inspector Tracy 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 under Regulation 174.
Alongside this Tracy supported the drafting of the GMP Annex 1 update and presented widely 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 product 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.
- MHRA Annex 1 drafting team member
- 10 years as a GMP Inspector
- 3 years as Expert GMDP Inspector
- Collaboration with European and international regulatory authorities
- MHRA Data Integrity GXP lead
Recent speaker requests
Tracy has spoken at several key events giving her former regulator insights, here are some of the highlights.
- PHSS Aseptic Processing and Contamination Control Workshop Syndicates 2022
- 2022 PDA Annex 1 Workshops; Dallas, Dublin, Amsterdam and Palm Springs
- 2022 PDA Quality & Regulations Conference