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What should we do if our warehouse temperature-control air-conditioning system fails overnight, causing the temperature to go out of range?

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

Q384 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)
This is an emergency that must be handled immediately and systematically. First, once the fault is detected through the alarm system, send someone to the site immediately to assess the situation and arrange repairs as soon as possible. Second, record the incident immediately as a “deviation”, noting when the fault occurred, when the temperature first went out of range, the highest temperature reading, and the affected areas and medicines. Third, immediately quarantine all affected medicines in the “quarantined goods pending examination” area and label them clearly. They must not be dispatched under any circumstances. Fourth, contact the manufacturer of the medicines concerned or consult their stability data to assess the specific impact of this brief temperature excursion on medicine quality. Some medicines may tolerate short-term temperature fluctuations for a certain period, while others are highly sensitive. Finally, the medicines may be considered for release again only after a written assessment from the manufacturer confirms that their quality has not been affected. Otherwise, they must be destroyed in accordance with the procedure. The entire process must be fully documented.

📘 Regulatory basis

The Code of Practice for Licensed Wholesale Dealers requires storage conditions to be monitored continuously, with any deviations investigated and recorded. This is a core requirement of the quality management system.

📗 Drew Tang's recommendations

Prevention is better than cure. We strongly recommend that clients install backup air-conditioning systems and generators in critical temperature-controlled warehouses. A reliable 24-hour temperature alarm system with remote notifications is an essential investment. Establish communication channels with medicine manufacturers in advance so that technical support can be obtained quickly if such an incident occurs. Prepare a detailed emergency SOP and conduct drills with staff to ensure they know what to do in a real emergency.

📕 Risk notice

Mishandling a temperature excursion or attempting to conceal it is extremely dangerous. Supplying medicines that may have deteriorated to customers directly endangers patient safety. If a Department of Health inspection finds that you have temperature excursion records but did not investigate or deal with them appropriately, this will be considered a critical deficiency, demonstrating a complete failure of your quality system and potentially justifying suspension or revocation of your licence.

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