Annual self-inspection is an important part of a licence holder’s Quality Management System (QMS) and is a proactive internal compliance audit. Its purpose is to systematically and critically review all company activities related to medicine quality, assess ongoing compliance with Good Distribution Practice (GDP) or Good Manufacturing Practice (GMP) requirements, and identify areas for improvement. It differs from a Department of Health inspection in three main respects: first, in nature—the former is an internal, proactive activity, while the latter is an external regulatory activity; second, in purpose—self-inspection aims at self-improvement and continual improvement, while a Department of Health inspection aims at enforcement and oversight; and third, in frequency and scope, which can be more flexible, allowing the company to conduct more frequent internal audits of high-risk areas based on risk assessment.
HONG KONG DRUG LICENSING
What is an annual “Self-Inspection”? How does it differ from a Department of Health inspection?
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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