Q308 · What is an Internal Audit in a Quality…

Q308 · Category G: Quality management and compliance systems (Q301–Q350)

An internal audit, also known as self-inspection, is a proactive, forward-looking quality assurance activity within a QMS. It is a systematic process, independent of the department being audited, to assess whether the company’s activities consistently comply with GDP requirements and its internal SOPs, and to identify opportunities for improvement. The audit should cover all areas related to medicine quality, including personnel, premises and facilities, equipment, documents and records, and operating procedures. A formal report must be issued after the audit, detailing deficiencies identified. The relevant departments must then develop and implement corrective and preventive action (CAPA). This is a key driver of the continuous improvement cycle.

📘 Regulatory basis

The Good Distribution Practice (GDP) for Medicinal Products expressly requires licensees to conduct regular self-inspections to monitor the implementation of and compliance with GDP principles, and to propose any necessary corrective measures. All self-inspection procedures and records must be documented.

📗 Drew Tang's recommendations

To ensure objectivity, internal auditors should have appropriate training and knowledge and be independent of the activities they audit. If internal resources are limited, you could consider engaging an independent external auditor, such as Rengangyongsheng (Hong Kong) Limited, which can often provide deeper, unbiased insights. We recommend conducting a comprehensive internal audit at least once a year, with more frequent audits for critical or new processes. Treating an internal audit as a “rehearsal”, rather than an “exam”, helps you get more value from it.

📕 Risk notice

Never conducting internal audits, or conducting them as a mere formality (for example, reporting “no deficiencies” every time), is a clear sign to regulators that the QMS is ineffective. It indicates that the company lacks a culture of self-criticism and continual improvement. If a regulatory inspection identifies numerous problems that should have been found and corrected through internal audits, the company may face more severe criticism and penalties.

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.

What is an Internal Audit in a Quality Management System? Who should conduct it, and how often?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang