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Does the area for keeping documents and records (the office) need to be separated from the medicine storage area?

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

Q173 · Category D: Premises and Storage Requirements (Q151-Q200)
Yes, the office area used to store documents and records must be separate from the medicine storage area. This separation is mainly for several reasons. First, offices are areas with high levels of staff activity, and separating them can reduce disturbance to the medicine storage environment and the risk of potential contamination. Secondly, offices do not usually require the strict temperature and humidity controls needed in a medicine warehouse. Separating the two can reduce energy costs and management complexity. Thirdly, paper documents and office equipment present a certain fire risk, so keeping them separate from the medicine storage area is a fire-safety measure. Ideally, the office should be a separate room. If space is limited, the office area must still be completely separated from the storage area by a partition wall or clear physical barrier, and activities in the office must not adversely affect the storage environment (such as temperature, humidity or cleanliness).

📘 Regulatory basis

Good Distribution Practice (GDP) emphasises functional segregation, requiring the layout and design of premises to prevent confusion and cross-contamination between different operational areas. Although it does not expressly require the office to be a separate room, separation is a fundamental principle.

📗 Drew Tang's recommendations

We recommend that clients plan to locate the office near the warehouse entrance. This allows visitors and administrative staff to complete most tasks without entering the core storage area, helping to strengthen access control and security management. The door between the office and the warehouse should remain closed.

📕 Risk notice

Placing a desk directly between pharmaceutical-product shelves is wholly unacceptable. This breaches the principle of functional zoning and creates multiple risks, including contamination, security and fire risks. Department of Health inspectors would immediately deem the premises design unsatisfactory, as it demonstrates a basic lack of understanding of the special requirements for pharmaceutical-product storage.

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