Andrew D. Hopkins AbbVie, Inc.

Andrew Hopkins has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His has worked in the industry over 35 years.

Currently Andrew is a Director Microbiological Contamination Control the role includes Liaison with Engineering for key project designs, training and mentoring, guidance on the implementation of Annex 1 and interaction with regulatory agencies.

Prior to this, Andrew was an Inspector with the MHRA for nearly 14 years. This role included:

• Routine (and less routine!) inspections across the world, including joint inspections with a number of other regulators (USFDA, TGA, TFDA and Health Canada) in a number of technical areas including, sterile products, biological products, blood components and plasma.
• Chairperson of the Inspectorates Compliance Management Team (working with marginally compliant companies to support them back to full compliance)
• Part of the MHRAs inspection Action Group (taking actions regarding non-compliant sites)
• Inspector training and mentoring
• Taking part in the writing of regulatory guidance documents including:
  • MHRAs Data Integrity guidance
  • EMA guidance on water systems
  • Chair for the working group for the revision of Annex 1
  • MHRA blog regarding the fragility of VHP
• Supporting external industry bodies with technical monographs e.g. PDA TR1 and PHSS TM20.

Prior to joining the MHRA Andrew worked for more than 20 years in a number of different areas and technologies in the Pharmaceutical industry. These included QA, Validation and Production Management in both sterile and non-sterile manufacturing facilities.