About Us

Introduction

The GMP Inspection Team is a part of the Licensing and Compliance Division of the Drug Office of the Department of Health and consists of the Manufacturers Regulatory Unit (“MRU”) and Wholesalers Regulatory Unit (“WRU”). The GMP inspection team is responsible for conducting inspections on and assessing the compliance of licensed manufacturers with the conditions of the relevant licence, the Laws of Hong Kong and the Good Manufacturing Practice (“GMP”) Guide issued by the Pharmacy and Poisons Board of Hong Kong (“the Board”).

What is Good Manufacturing Practice (“GMP”)?

GMP is that part of quality assurance which ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization or product specification.

What do we do?

The Board is responsible for licensing and regulatory control of manufacturers of pharmaceutical products. The MRU and WRU provides executive support to the Executive Committee established under the Board, i.e. the Pharmacy and Poisons (Manufacturers Licensing) Committee (“the Committee”), by assessing new applications for a Licence for Manufacturer or applications for change of licensed particulars and by conducting inspections in order to make recommendations to the Committee for decision on licensing issues.