01.01.2000

Supervisor of GMP inspections and Ministerial Pharmaceutical Director at the Ministry of Social Affairs

Michael Hiob, PhD

Michael Hiob, PhD

After graduating in pharmacy and receiving a PhD, Michael Hiob worked as Laboratory Manager and GMP Inspector in the area of drug supervision. He is currently inter alia responsible for supervising GMP inspections

Michael Hiob is a member of the Working Group on Drugs, Pharmacies, Transfusions and Narcotics (AG AATB) of the supreme state health authorities of the German Länder.

He was head of the German GMP inspectors' expert group on qualification and validation for more than ten years. He was (co-)author of the German Aide Mémoire on inspections of validation and qualification in pharmaceutical production and quality control. He also served on international committees, including as an expert at the European Medicines Agency (EMA).

He is author or co-author of the following chapters of GMP Compliance Adviser:

  • 1.D Change Management
  • 2 Personnel (except for 2.C)
  • 3.A Official requirements for premises
  • 6.A Official requirements and agency expectations
  • 7.A Official requirements and agency expectations
  • 8.A Official requirements and agency expectations
  • 15.A Official Requirements
  • 21.A Supervision of medicinal products in Europe
  • 21.B Official inspections
  • B.2 Government Authorities in Europe



Back