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What structure should be followed when drafting SOPs for a medicine wholesaling business to ensure that they are clear, compliant and easy to implement?

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

Q302 · Category G: Quality management and compliance systems (Q301–Q350)
Standard Operating Procedures (SOPs) are the backbone of a Quality Management System, providing specific, consistent guidance for key operations. Professional, properly structured SOPs not only ensure consistency in staff operations but are also important documents for demonstrating a company’s compliance to the regulatory authorities. When drafting them, ensure that the content is comprehensive and logically clear. A standard SOP should include at least the following: document title, unique SOP number, version number, effective date, drafter/reviser, reviewer, approver, clearly stated “purpose” and “scope”, allocation of “responsibilities” among relevant personnel, a “procedure” described in specific steps, and attachments containing forms for the “records” to be completed during the operation. This structure ensures that the SOP is complete, traceable and authoritative, enabling it to provide genuine guidance in day-to-day work.

📘 Regulatory basis

The Drug Office, Department of Health’s Good Distribution Practice (GDP) for Pharmaceutical Products clearly requires licensed wholesalers to establish written SOPs for all critical activities that affect product quality, such as receipt, storage, picking, packing, transportation, handling of returned goods and product recalls.

📗 Drew Tang's recommendations

When drafting SOPs, always consider the perspective of the person carrying out the task. Use clear, concise language and avoid ambiguous wording. For complex processes, flowcharts, diagrams or checklists can make the steps easier to follow. Once the first draft is complete, it is best to have the employees who will carry out the SOP test it and provide feedback. All employees must also receive relevant SOP training, and training records must be retained; these are a key focus during inspections.

📕 Risk notice

Vague or outdated SOPs, or SOPs that staff do not follow consistently, are among the most common shortcomings identified during regulatory inspections. If inspectors find that actual practices do not match the SOPs, they will immediately question the seriousness of the company’s quality control. This may lead to a warning letter, a requirement to take corrective action or even more severe penalties.

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