Q324 · What is a Site Master File (SMF)? Do…

Q324 · Category G: Quality management and compliance systems (Q301–Q350)

A Site Master File (SMF) is a document prepared by a licence holder describing how its activities related to licensed operations (such as medicine wholesale) comply with GDP. It is like a “CV for the premises”, giving the regulatory authority a concise, comprehensive overview of the company’s quality management policy, personnel, facilities, equipment, documentation system and specific operations. Its contents usually follow a standard format, including company information, an overview of the QMS, personnel and organisation, a description of the factory premises and equipment, document management, and summaries of key operating procedures (such as procurement, storage, distribution and recall). An SMF is mandatory for medicine manufacturers. Although it is not legally mandatory for wholesalers in Hong Kong, preparing one is strongly recommended as best practice.

📘 Regulatory basis

The PIC/S GMP Guide sets out detailed requirements for the format and contents of an SMF (PE 008-4). Although this document is directed at manufacturers, its framework and principles are also highly relevant to wholesalers seeking to demonstrate their GDP compliance clearly to regulators.

📗 Drew Tang's recommendations

We strongly recommend that our clients proactively prepare and maintain an SMF. When applying for a licence or undergoing an inspection, proactively submitting a detailed and well-structured SMF can greatly help inspectors understand your operations quickly and demonstrate your professionalism and transparency, creating a good first impression. It is also a useful self-assessment tool that helps you review your compliance status systematically.

📕 Risk notice

Although failure to prepare an SMF will not itself directly result in a penalty, the absence of such a guiding document may make communication difficult and inefficient during a complex inspection. If inspectors spend too much time establishing basic facts, this may affect their overall assessment of your company’s management maturity.

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 a Site Master File (SMF)? Do pharmaceutical wholesalers need to prepare one?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang