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What is Good Manufacturing Practice (GMP)? How does it differ from and relate to Good Distribution Practice (GDP)?

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

Q304 · Category G: Quality management and compliance systems (Q301–Q350)
Good Manufacturing Practice (GMP) is a set of mandatory standards applicable throughout the medicine manufacturing process. It aims to ensure the consistent production of medicines that meet quality standards and regulatory requirements by strictly controlling key factors such as personnel, premises, equipment, materials, methods and the environment. Good Distribution Practice (GDP), by contrast, focuses on the supply chain after medicines leave the production line, including procurement, storage, transport and distribution. In brief, GMP governs “manufacture” and ensures products are “manufactured to the required standard”; GDP governs “distribution” and ensures that product quality does not deteriorate before compliant products reach the end user. Together, they form an integrated quality assurance system for medicines from the beginning to the end of the supply chain; both are closely linked and indispensable.

📘 Regulatory basis

In Hong Kong, GMP is primarily based on the GMP Guide published by the Pharmaceutical Inspection Co-operation Scheme (PIC/S), of which the Department of Health is a member. GDP follows the Department of Health Drug Office’s Good Distribution Practice Guide for Pharmaceutical Products. Both are important technical guidelines within the framework of the Pharmacy and Poisons Ordinance (Cap. 138).

📗 Drew Tang's recommendations

Although wholesalers are not directly involved in manufacturing, it is essential for them to understand GMP. GDP requires you to ensure that medicines procured are from manufacturers holding valid GMP certificates. Be sure to review suppliers’ evidence of GMP compliance. Your own GDP system should also interface effectively with the quality standards of upstream manufacturers. For example, when handling product complaints or recalls, it should work efficiently with the manufacturers’ GMP systems.

📕 Risk notice

As a wholesale dealer, procuring medicines from a source without GMP qualifications is a serious offence. This not only exposes your business to legal penalties but also places the public at significant risk from medicines. The regulator takes a zero-tolerance approach to such conduct. If discovered, your Wholesale Dealer Licence may be revoked immediately, and you may face criminal prosecution.

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