An on-site inspection is a key stage in the approval process and usually takes place after an application has been submitted and passed an initial review. A pharmacist inspector will visit your proposed premises to conduct a thorough inspection and verify that you have the operational capability to comply with the law. The inspection will focus mainly on the following: first, checking that the actual layout, facilities and equipment match the submitted plan and meet medicine storage requirements, such as temperature and humidity monitoring, pest control and security systems. The inspector will then assess your Quality Management System, sample-check your Standard Operating Procedure (SOP) documents and may ask the Person-in-Charge about the procedures they contain. Finally, the inspector will interview the Responsible Person (RP) to assess their understanding of the regulations, their awareness of their duties and their ability to handle unexpected incidents. The inspection is intended to ensure that both your physical facilities and management systems can safeguard the quality and safety of medicines during distribution.
HONG KONG DRUG LICENSING
What do on-site inspections by Department of Health pharmacist inspectors (Site Inspection) focus on?
A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.
Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.
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