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What requirements apply to the design and management of medicine warehouse loading and unloading areas (Loading/Unloading Bays)?

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

Q180 · Category D: Premises and Storage Requirements (Q151-Q200)
Loading and unloading areas are the points through which medicines enter and leave the premises, and their design and management are essential to protecting medicine quality. First, the area should provide sufficient protection from adverse weather, such as direct sunlight and rain, while medicines are being loaded or unloaded. Ideally, it should be fully enclosed or at least covered by a roof. Second, it should be well separated from the external environment, for example by using rapid roller shutters, to reduce the impact of insects, dust and temperature and humidity fluctuations on the warehouse interior. Third, the floor should be level and sturdy to facilitate the use of handling equipment. Fourth, the area must be clearly divided, with receiving and dispatch areas appropriately separated to prevent confusion between finished goods about to be dispatched and quarantined goods pending examination that have just been received. Finally, the area should be kept clean and orderly, free from clutter and sufficiently well lit to allow inspection of goods labels and appearance.

📘 Regulatory basis

Good Distribution Practice (GDP) expressly requires that “receiving and dispatch areas should protect goods from the weather. The design and equipment of the receiving area should allow incoming containers to be cleaned before receipt. There should be adequate space for the orderly handling of goods”.

📗 Drew Tang's recommendations

We recommend that clients install a dock leveller and dock seal at the loading bay to create an enclosed passage between the lorry and the warehouse. This can greatly improve environmental control as well as loading and unloading efficiency and safety. It is a hallmark facility of a modern pharmaceutical warehouse and will make a very professional impression on inspectors.

📕 Risk notice

Loading and unloading medicines in the open is unacceptable, especially in rain or direct sunlight. This exposes medicines to uncontrolled temperature and humidity conditions and contamination risks. If your loading area is disorderly, with incoming and outgoing medicines mixed together, this will be regarded as a serious risk of cross-contamination and dispatch errors, and a major inspection deficiency.

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