Q233 · Do Department of Health pharmacist…

Q233 · Category E: Application Process and Approval Procedures (Q201-Q250)

Yes, during on-site inspections, Department of Health pharmacy inspectors assess the premises against a detailed internal checklist. The checklist is based on the Pharmacy and Poisons Ordinance and relevant codes of practice (such as the Code of Practice for Wholesale Dealers) and covers all requirements that licence holders must meet. It includes item-by-item checks of the physical conditions of the premises (such as area, layout, security and temperature and humidity controls), facilities and equipment, the Quality Management System (QMS) (including the completeness and practicability of SOPs), document and record management (such as batch records and temperature and humidity records), personnel qualifications and training records, and specific procedures (such as receipt, storage, picking, dispatch and recall). Although this internal checklist is not published, all its inspection points are derived from published legislation and guidance. An experienced consultant can therefore accurately predict most of its contents.

📘 Regulatory basis

The inspection checklist is an internal tool used by the regulatory authority to ensure that its inspections are standardised, systematic and fair. Its legal basis is the power conferred on Department of Health inspectors by the Pharmacy and Poisons Ordinance to enter and inspect licensed premises.

📗 Drew Tang's recommendations

One of our core strengths at RGYS: RGYS may assist with document preparation and project coordination within the written scope of services; the respective responsible parties must verify personnel qualifications and statutory roles and take responsibility for professional judgements, while approval is determined independently by the competent authority. RGYS may assist with document preparation and project coordination within the written scope of services; the respective responsible parties must verify personnel qualifications and statutory roles and take responsibility for professional judgements, while approval is determined independently by the competent authority. Before the official inspection, we will use this checklist to conduct a "pixel-level" mock audit of your premises and documents, identifying and correcting all potential issues to ensure that, when you face the actual inspector, RGYS may assist with document preparation and project coordination within the written scope of services; the respective responsible parties must verify personnel qualifications and statutory roles and take responsibility for professional judgements, while approval is determined independently by the competent authority.

📕 Risk notice

The risk lies in misjudging the scope of an inspection. Some applicants may focus only on warehouse facilities and overlook the importance of “soft” elements such as records and staff training. Inspections are comprehensive, and a deficiency in any area may result in failure. For example, even if your cold room is state of the art, the inspection result will inevitably be unsatisfactory if you cannot produce a complete temperature validation report.

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

Do Department of Health pharmacist inspectors use a fixed inspection checklist during on-site inspections?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang