What specific requirements does Hong Kong’s Good Distribution Practice (GDP) set for temperature and humidity monitoring in storage facilities, and how can we meet them?

Good Distribution Practice (GDP) requirements for temperature and humidity control are very strict because improper storage conditions can directly affect the stability and efficacy of medicines. First, medicines must be stored according to the label instructions (such as “Store below 25°C” or “Refrigerate at 2–8°C”). The warehouse must be equipped with a sufficient number of calibrated temperature and humidity monitoring devices to record data continuously. Based on the results of a temperature mapping study, the probes should be strategically positioned at points in the warehouse representative of extreme temperatures (the highest and lowest). Data records should be reviewed regularly (for example, daily). Any deviation from the pre-set range must be documented, and corrective and preventive action (CAPA) taken immediately. Backup power and alarm systems should also be provided to deal with unexpected power outages or equipment failures.