Hong Kong Drug Licence Applications and Acquisitions · RGYS|Global Licensing and Compliance Service Provider
Hong Kong pharmaceutical compliance · applications / acquisitions / ongoing maintenance Independent Third-Party Service Provider
HONG KONG DRUG LICENSING

What should a detailed internal audit (self-inspection) report include?

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

Q349 · Category G: Quality management and compliance systems (Q301–Q350)
An internal audit report is a key document for recording audit findings and driving subsequent improvements; its quality directly affects the effectiveness of the audit. A detailed report should be clearly structured and specific. It should include at least the following sections: 1. **Basic information**: unique audit reference, audit date, scope (such as “storage operations” or “document system”), audit criteria (such as GDP guidance or company SOPs), auditor’s name and the department audited. 2. **Audit summary**: a brief overview of the audit and its main conclusions. 3. **Audit findings**: the core of the report. Clearly list each non-conformity (deficiency) separately. Describe the specific facts observed in detail (“where I was and what I saw”) and cite the specific legislative or SOP provision breached. 4. **Deficiency grading**: grade each deficiency according to its potential impact on product quality and regulatory compliance (for example, “critical”, “major” or “minor”). 5. **Recommendations (optional)**: the auditor may suggest improvements, but the audited department should determine the final corrective actions. 6. **Report distribution list and conclusion**.

📘 Regulatory basis

Self-inspections must be recorded under the Good Distribution Practice (GDP) for Medicinal Products, and the records should include all observations and proposed corrective measures. A structured report is the standard way of meeting this requirement.

📗 Drew Tang's recommendations

When describing audit findings, remain objective and fact-based, and avoid subjective or accusatory language. A good finding should enable anyone reading it to recreate the situation. For example, instead of writing ‘staff training was inadequate’, write ‘In the third-floor warehouse, staff member Zhang San did not follow the picking steps in SOP-W-005. When asked, he said that he was not familiar with the SOP.’ Such a description is compelling and effectively points to the root cause.

📕 Risk notice

An internal audit report that is vague and lacking in detail is ineffective. It does not provide clear input for subsequent CAPA, nor does it demonstrate to the regulator that a thorough, professional self-inspection was carried out. If the report always says “everything is fine”, or the issues it raises are trivial, the regulator may suspect that your internal audits are merely a formality.

Back to Category G: Quality Management and Compliance Systems (Q301-Q350) Search more questions

YOUR NEXT STEP

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.

Book a Project Assessment ↗