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What contingency plans should be in place for unexpected power outages at a pharmaceutical warehouse, particularly for cold-chain storage?

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

Q179 · Category D: Premises and Storage Requirements (Q151-Q200)
A sudden power failure is a major risk for a medicines warehouse, particularly one storing cold-chain medicines. An adequate emergency plan should address several areas. First, **prevention and alerts**: all critical cold-chain equipment (cold rooms and refrigerators) should be connected to an uninterruptible power supply (UPS) and/or a backup generator. The temperature monitoring system itself should also have an independent backup battery and be able to send an alert to the person-in-charge immediately over a 4G/5G network in the event of a power failure. Second, **immediate response**: the plan should clearly identify the person responsible and their duties upon receiving an alert, such as going to the site immediately to check whether the generator has started or assessing the likely duration of the power failure. Third, **alternative arrangements**: if the power failure is expected to last a long time, beyond the capacity of the generator’s fuel supply or the UPS, the plan must provide for the safe transfer of medicines to an alternative storage site. This could be another compliant cold room with power, or emergency storage services arranged with a third-party logistics provider. All emergency operations must be documented in detail.

📘 Regulatory basis

Good Distribution Practice (GDP) requires contingency plans for all emergencies that may affect the quality of medicines, such as equipment failures. Maintaining continuous temperature control is a core requirement for cold-chain products, so a power failure contingency plan is essential.

📗 Drew Tang's recommendations

We strongly recommend that all clients storing cold-chain medicines invest in an automatic-start backup generator with a capacity matched to the cold room, and test it regularly to ensure it is ready for use at all times. For small quantities of medicines, you can prepare validated passive cool boxes that can maintain a low temperature for an extended period as temporary transfer equipment. Prepare a clear emergency contact list including 24-hour telephone numbers for the electricity supplier, generator repair service and emergency logistics partners.

📕 Risk notice

Having no written power-cut contingency plan is a serious management deficiency. If, during an inspection, you cannot explain how you would protect your cold-chain medicines during a power failure, your licence application will face considerable risk. A prolonged power cut without effective contingency measures could result in medicines worth millions being written off, with devastating consequences for the company.

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