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How should we manage and control our company's Standard Operating Procedure (SOP) documents?

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

Q386 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)
Standard Operating Procedures (SOPs) are the foundation of a Quality Management System, ensuring operational consistency and compliance. SOP management must be strict and systematic. This includes: 1. Drafting and review: SOPs should be drafted by personnel familiar with the operation, reviewed by the relevant departments (such as the user department and quality department), and ultimately approved by the head of the quality department. 2. Version control: Every SOP must have a unique number, version number and effective date. Any amendment must follow the change control procedure and result in a new version number. Superseded SOPs must be withdrawn immediately from all points of use to prevent misuse. 3. Distribution and training: Controlled copies of SOPs should be distributed to all roles that need to carry out the relevant operations. Relevant employees must be trained before an SOP takes effect, and the training must be documented. 4. Periodic review: All SOPs should be reviewed periodically (for example, every two years) to ensure that their content remains accurate and applicable. If regulations or processes change, they should be revised immediately. 5. Archiving: The master copy of every SOP and all historical versions should be properly archived.

📘 Regulatory basis

Both GMP and GDP guidelines require written procedures to cover all key operations that affect medicine quality, and require these procedures to be properly controlled and managed.

📗 Drew Tang's recommendations

We recommend using an electronic document management system (EDMS) to manage SOPs. This can greatly simplify version control, distribution, retrieval and training record management, while ensuring that employees can always access the latest, sole correct version. SOPs should use clear, concise and unambiguous language, with flowcharts and diagrams used extensively to make them easy to understand and follow.

📕 Risk notice

Poor SOP management is a common inspection deficiency. If staff are found using an obsolete SOP at the workplace, or if actual operations do not match the SOP, this will be regarded as a major deficiency. It indicates that your written procedures are disconnected from actual operations and that your quality system is ineffective. If a quality incident results from following an incorrect SOP, the company will be held responsible.

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