Q372 · What is a warehouse “Temperature Mapping…

Q372 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)

A temperature mapping study (also known as temperature distribution validation) is a scientific validation exercise. It involves placing sufficient temperature probes at different locations within a warehouse or cold room, including high, low and middle positions and locations near doors, windows and air-conditioning outlets, and continuously recording data over a period of time (usually 7 consecutive days, covering the hottest and coldest seasons). The aim is to identify the hottest and coldest points in the warehouse and demonstrate that temperatures throughout the storage space can be maintained consistently within the specified range, such as 15–25°C or 2–8°C. For all pharmaceutical wholesalers and manufacturers requiring temperature-controlled storage, temperature mapping studies are a mandatory GDP/GMP requirement. They form the basis for demonstrating that your storage facilities can continuously safeguard medicine quality.

📘 Regulatory basis

Both the Code of Practice for Licensed Wholesale Dealers and the PIC/S GDP/GMP guidelines expressly require temperature mapping studies to be conducted before a new temperature-controlled storage area is brought into use, to confirm its performance. Revalidation is required after major refurbishment.

📗 Drew Tang's recommendations

We recommend outsourcing temperature mapping studies to a specialist validation service provider. On completion of the study, you will receive a detailed report. This report should guide you to place routine monitoring probes at the “worst-case” locations identified by the study (the hottest and coldest points), because if these locations meet requirements, the temperatures in other areas are likely to meet them too. The study should be repeated periodically (for example, every 3 years) or whenever there is a major change to the warehouse layout.

📕 Risk notice

Without a temperature mapping study, or if the study is not properly conducted, you cannot scientifically demonstrate that your warehouse meets temperature-control requirements. This will be regarded as a major deficiency during a Department of Health inspection. If your routine temperature-monitoring probe happens to be placed in the “good” location where the temperature is most stable, while the hottest spot has already exceeded limits, all your temperature records may be invalid and the quality of the medicines stored may be at serious risk.

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 warehouse “Temperature Mapping Study”? Do we have to conduct one?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang