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What should warehouse staff training records include to demonstrate that staff are qualified to carry out their duties?

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

Q182 · Category D: Premises and Storage Requirements (Q151-Q200)
Staff implement the quality management system, and their training records are important evidence to the regulator that they are “competent” to perform their duties. A complete training file should systematically document all training received by an employee from induction through to their ongoing employment. It must include: 1. **Basic training**: training on the company's quality policy, basic pharmaceutical regulatory requirements (such as GDP) and personal hygiene requirements. 2. **Role-specific SOP training**: training on the SOPs relevant to each employee's role; for example, goods-receiving staff should be trained on the goods-receiving SOP and picking staff on the picking SOP. 3. **Specific skills training**: for cold-chain activities, training in cold-chain management and emergency procedures; for handling dangerous medicines, training in relevant legislation and safe handling procedures. 4. **Ongoing training**: regular updates on GDP and training on new SOPs. Each training record should include the date, subject, training materials and trainer, and, most importantly, the trainee's signature and assessment results (where applicable) as evidence that they have understood the training.

📘 Regulatory basis

Good Distribution Practice (GDP) expressly states that “all personnel involved in wholesale distribution activities should receive training relevant to their responsibilities” and requires that “training records should be kept and the effectiveness of training should be periodically assessed”.

📗 Drew Tang's recommendations

We recommend that clients maintain an individual training file for each employee and draw up an annual training plan. When new employees join, in addition to SOP training, assign an experienced employee as a mentor to provide on-the-job training and guidance. Linking training records to employees’ job descriptions makes it easier to demonstrate to inspectors that training is relevant and effective.

📕 Risk notice

If training records are missing or incomplete (for example, they state only the training topic and lack staff signatures), this is treated as if no training took place. If staff cannot explain the SOPs relevant to their roles during an inspection, this is not merely an individual employee issue; it is a serious failure of the company’s training system and management, and will directly affect the licence application outcome.

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