Cold-chain medicine management is a major focus of GDP and requires the specified temperature (usually 2-8°C) to be maintained without interruption throughout the supply chain. Key quality control points apply throughout. On receipt: immediately check the temperature data logger in the refrigerated container or vehicle to confirm that temperatures did not exceed the limits during transport, and check the outer packaging for signs of condensation or frost. During storage: use a dedicated cold room or refrigerator that has undergone temperature mapping and is continuously monitored, with an audible and visual alarm system and backup power. On dispatch: use validated insulated shippers and coolants, selecting the packaging configuration according to the estimated transport time and external ambient temperature. At handover, ensure that the recipient can transfer the medicines immediately to compliant refrigeration equipment.
HONG KONG DRUG LICENSING
For medicines requiring cold chain transport, what are the key quality control points throughout the process from receipt and storage to dispatch?
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.
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