Q153 · What are the specific technical requirements…

Q153 · Category D: Premises and Storage Requirements (Q151-Q200)

For medicines requiring constant-temperature storage (usually in the range of 15-25°C), the temperature and humidity control system is a core facility for ensuring medicine stability. The technical requirements mainly include the following. First, a commercial-grade air-conditioning system capable of covering the entire storage area and operating continuously must be installed. Second, calibrated temperature and humidity loggers must be installed at multiple representative locations in the warehouse for uninterrupted 24/7 monitoring. These locations should include the centre and corners of the warehouse, and areas near doors, windows or heat sources. Third, the system must have high- and low-temperature alarms that immediately notify designated personnel by audible and visual alerts, text message or email when temperature or humidity falls outside the preset range. Finally, all temperature and humidity data must be fully recorded and retained for at least one year after the medicines’ expiry dates, so that the Department of Health can inspect them at any time.

📘 Regulatory basis

The Good Distribution Practice (GDP) requirements under the Pharmacy and Poisons Ordinance require storage conditions to be controlled and monitored. Medicines requiring storage at a specific temperature should be monitored continuously using appropriate equipment (such as temperature and humidity data loggers), and relevant records must be kept. Equipment calibration is also mandatory.

📗 Drew Tang's recommendations

We strongly recommend that clients invest in an automated, cloud-based temperature and humidity monitoring system. Such systems not only provide real-time data and remote alerts, but can also automatically generate reports that meet regulatory requirements, greatly reducing the burden and risk of errors associated with manual record-keeping. When selecting equipment, be sure to obtain and check the supplier's Calibration Certificate, and establish an annual calibration plan.

📕 Risk notice

Installing a household air conditioner alone is wholly inadequate. Department of Health officers will carefully examine the continuity and completeness of temperature and humidity records and whether probe placement is appropriate. Any interruption in records, missing data or unrepresentative probe locations may result in an unsatisfactory inspection. Uncontrolled temperature and humidity may cause pharmaceutical products to degrade and lose efficacy, resulting in a serious quality issue.

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 are the specific technical requirements for temperature and humidity control systems for medicines requiring storage at a constant temperature?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang