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Should my QMS include a business continuity plan (BCP) or contingency plan?

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

Q330 · Category G: Quality management and compliance systems (Q301–Q350)
Yes, a mature QMS should include a Business Continuity Plan (BCP) to address unexpected events that may interrupt your critical operations. Such events may include natural disasters (such as a typhoon causing a power failure), fire, serious IT system failures, the collapse of a key supplier or the warehouse becoming unusable. The core purpose of a BCP is to identify these risks in advance and establish an action plan to ensure that critical products and services can continue to be provided at a predetermined, acceptable level during a crisis. This is particularly important for medicine wholesalers, as an interruption to medicine supply may directly affect patient treatment. The plan should include an emergency command structure, internal and external communication arrangements, data backup and recovery procedures, and arrangements for alternative facilities or suppliers.

📘 Regulatory basis

Although GDP does not expressly require a complete BCP in the same way as financial regulation, its principles underpin multiple requirements, such as backup power and alarm systems for cold rooms and reliable data backup procedures. These are all components of a BCP. A quality system that cannot respond to unexpected events is incomplete.

📗 Drew Tang's recommendations

Start by identifying the few key processes that matter most to your business, such as the storage and distribution of cold-chain medicines. Then consider the most likely disruption scenarios for those processes and establish simple, practical response steps. For example, enter into a framework agreement with a backup cold-chain transport company. Test your contingency plan regularly, such as checking that a backup generator starts or that data can be restored from a backup. Treat your BCP as an investment in your business resilience.

📕 Risk notice

In a crisis, a company without an emergency plan can fall into disarray and make poor decisions, potentially worsening the impact on medicine quality and supply. For example, following a prolonged power cut, the entire stock of cold-chain medicines in a warehouse could be lost if there is no backup power supply or emergency relocation plan. Showing the regulatory authorities that you are prepared for foreseeable emergencies will greatly increase their confidence in your management capabilities.

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