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How can effective zones be designed inside a medicine warehouse (such as areas for goods pending examination, released goods and returns)?

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

Q154 · Category D: Premises and Storage Requirements (Q151-Q200)
Effective zoning is fundamental to preventing medicine mix-ups and cross-contamination. First, each functional area must be clearly physically separated. Separate rooms or solid walls are ideal; if this is not possible, sturdy partitions, barriers or cage trolleys must be used to create clear separation. Second, every area must have prominent, firmly affixed signs naming the area in both Chinese and English, such as “待验区/Quarantine Area”, “合格品区/Approved Stock Area” and “不合格品区/Rejected Stock Area”. Third, the movement of materials between areas must be strictly controlled by procedures. For example, all newly received medicines must first be placed in the quarantine area. They may only be moved to the released goods area after inspection by the quality control department and issue of release authorisation. Any returned, recalled or damaged medicines must be isolated immediately in the non-conforming goods area pending further action.

📘 Regulatory basis

Good Distribution Practice (GDP) is explicit about functional segregation. It states that “physically separated areas or areas separated by other effective means should be provided for the storage of medicines pending examination, non-conforming medicines, returned medicines or recalled medicines” to prevent them from entering saleable stock without authorisation.

📗 Drew Tang's recommendations

We recommend that clients use different-coloured paint or tape on the floor to mark the boundaries of each area. This is a low-cost and highly visible way to reinforce zoning controls. For example, use yellow for the quarantine area, green for released goods, and red for non-conforming goods. This visual management approach can effectively reduce operator errors and is well regarded by Department of Health officials.

📕 Risk notice

A single line of adhesive tape or a verbal instruction is far from sufficient to define a segregated area. The Department of Health requires “effective segregation”. If products with different statuses are found stored in the same area or are not clearly labelled during an inspection, this will be treated as a serious deficiency. This may not only result in the licence application failing, but also require the relevant operations to cease immediately until the deficiency is rectified.

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