Q357 · What essential training should we provide to…

Q357 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)

Staff are the first line of defence in ensuring medicine quality and compliant operations, so ongoing, effective training is essential. Necessary training should include: 1. Induction training covering the company's quality policy, basic GDP/GMP concepts, personal hygiene requirements, and employees' own roles and relevant Standard Operating Procedures (SOPs). 2. Role-specific skills training for particular tasks such as receipt, acceptance, storage, picking, packing and transport. 3. Medicine knowledge training, particularly on the characteristics, storage conditions and expiry-date management of the medicines handled. 4. Compliance and regulatory training to refresh staff regularly on relevant legislation, including the Pharmacy and Poisons Ordinance. Training records must be comprehensive and include the date, subject, outline of content, trainer, employee signatures and an assessment of training effectiveness. These records are key evidence to the regulator that you have fulfilled your training obligations.

📘 Regulatory basis

Both the Code of Practice for Licensed Wholesale Dealers and the Code of Practice for Licensed Manufacturers emphasise that all staff engaged in activities affecting medicine quality should receive initial and ongoing training appropriate to their duties, and that relevant training records should be retained.

📗 Drew Tang's recommendations

Training should not be a one-off event. We recommend that clients establish an annual training plan and adjust its content as needed in response to regulatory updates, the introduction of new products or issues identified during internal audits. A variety of methods, such as classroom teaching, on-the-job coaching, case studies and even prize quizzes, can improve staff engagement and learning outcomes. Linking training completion to staff performance appraisals can also be an effective incentive.

📕 Risk notice

Insufficient training or incomplete training records are common inspection deficiencies. If an employee causes a medicine quality issue because they do not understand the correct procedures, the company will bear full responsibility. In the event of a serious incident, inadequate training records will place the company at a considerable disadvantage in legal proceedings.

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

What essential training should we provide to employees who handle medicines? How detailed should the training records be?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang