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What hygiene and health requirements apply to personnel applying for a proprietary Chinese medicine manufacturer (GMP) licence?

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

Q137 · Category C: Eligibility and Personnel Requirements (Q101-Q150)
Proprietary Chinese medicine GMP (Good Manufacturing Practice) imposes strict hygiene and health requirements on all personnel involved in production, especially employees who come into direct contact with Chinese herbal medicines, semi-finished products or finished products. First, all relevant personnel must undergo a medical examination before taking up their duties to ensure that they do not have any infectious disease or skin condition that could contaminate medicines. Second, staff must receive systematic training in personal hygiene, including correct handwashing procedures and requirements for wearing clean work clothing. Before entering clean production areas, they must change into dedicated work clothing, footwear, headwear and masks. Eating, drinking, smoking and any other conduct that could contaminate medicines are strictly prohibited in production areas. If an employee develops any health condition that could affect medicine quality, such as a cold, diarrhoea or a skin wound, they must report it to their supervisor immediately and be temporarily reassigned from duties involving direct contact with products.

📘 Regulatory basis

The “Personnel” and “Hygiene” sections of the Good Manufacturing Practice Guide for Proprietary Chinese Medicines, issued by the Chinese Medicine Council of Hong Kong, set out detailed requirements concerning the health, personal hygiene and conduct of production personnel.

📗 Drew Tang's recommendations

We recommend that clients develop a comprehensive employee health and hygiene management system for the pharmaceutical factory. This should include employee health records, regular medical examinations, detailed personal hygiene SOPs and a procedure for reporting health abnormalities. These documented systems are important items of review during GMP certification inspections.

📕 Risk notice

Personnel are the least predictable factor in GMP management and the greatest potential source of contamination. If poor staff hygiene leads to medicines being contaminated by microbes or foreign matter, this constitutes a serious manufacturing quality incident. This may not only result in the destruction of the entire batch, but also undermine the regulator’s confidence in the factory’s entire quality management system.

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