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What core principles should be followed when planning a medicine warehouse layout to meet Department of Health requirements?

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

Q152 · Category D: Premises and Storage Requirements (Q151-Q200)
The layout of a medicine warehouse is key to ensuring medicine quality and safety. It must follow the principles of clear workflow, physical segregation and prevention of cross-contamination. First, clearly defined functional areas must be established, including receiving, quarantined goods pending examination, released goods, non-conforming goods (including returned, recalled, expired or damaged medicines) and dispatch areas. There should be clear physical boundaries between areas, for example, walls, partitions or clearly marked floor areas. Second, the layout should ensure a one-way workflow from receiving to dispatch, without crossing paths, to avoid confusion between medicines that have passed examination and those pending examination or deemed non-conforming. In addition, dedicated storage areas meeting the relevant requirements must be provided for medicines with special storage conditions (such as refrigeration, protection from light or controlled poisons).

📘 Regulatory basis

Good Distribution Practice (GDP) expressly requires the design and layout of premises to minimise the risk of errors and allow effective cleaning and maintenance. It particularly emphasises the separation of receiving, storage and dispatch areas, and the need for dedicated areas for special materials.

📗 Drew Tang's recommendations

When planning the layout, consider using a racking system instead of storing goods on the floor. This makes effective use of vertical space and better supports the ‘first expiry, first out’ (FEFO) / ‘first in, first out’ (FIFO) inventory management principles. In the warehouses we help clients design, each rack and storage location is usually coded and integrated with the warehouse management system (WMS), enabling precise location and traceability. This creates a highly professional impression when Drug Office officers inspect the premises.

📕 Risk notice

A confusing layout is one of the common reasons for a licence application to fail. If the quarantine area is not physically segregated from the released goods area, or returned medicines are left near released goods, this will be regarded as a serious breach. Such confusion may result in non-conforming medicines being dispatched in error, leading to a serious public health incident and exposing the company to the risk of licence revocation and legal proceedings.

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