Hong Kong Drug Licence Applications and Acquisitions · RGYS|Global Licensing and Compliance Service Provider
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During a site inspection, might inspectors question other staff as well as the Responsible Person (RP)?

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.

Drug Office, Department of Health Chinese Medicines Board

Q245 · Category E: Application Process and Approval Procedures (Q201-Q250)

📘 Regulatory basis

The Code of Practice for Wholesale Dealers stresses the importance of ongoing training for all staff engaged in wholesale activities. Spot questions are a direct way to assess the effectiveness of training and an effective means of checking whether SOPs are “embedded in staff practice”.

📗 Drew Tang's recommendations

“Everyone is ready for action” is our training philosophy. Before an inspection, we not only provide focused guidance to your RP but also offer tailored question-and-answer training and practice sessions for all your key staff, such as warehouse supervisors and quality assistants. We ensure that when inspectors ask questions, every team member can give confident, accurate answers that fully accord with your SOPs.

📕 Risk notice

The risk is that “only the RP understands it”. If inspectors find that staff other than the RP know nothing about the SOPs, or that actual practices differ significantly from the SOPs, they may reach a very negative conclusion: that your quality system is merely a “paper exercise” created to get through inspections. This would be a major deficiency and could well result in a failed inspection.

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