Although pharmaceutical wholesale does not have the extreme environmental requirements of sterile manufacturing, good personal hygiene remains a basic element in preventing medicine contamination. GDP requires companies to establish and implement relevant hygiene procedures. Your hygiene SOP should specify that: 1. All employees entering medicine storage and handling areas must wear clean work clothes; 2. Hands must be cleaned appropriately before handling medicines; 3. Employees who have an infectious disease that could contaminate medicines or open skin wounds must report it to a supervisor immediately and be temporarily removed from duties involving direct contact with medicines; 4. Eating, drinking, smoking or keeping personal food and belongings in medicine storage and handling areas is strictly prohibited; and 5. Personal clothing must be kept clean. These requirements are intended to minimise the risk of medicine contamination from human factors.
HONG KONG DRUG LICENSING
What are the specific GDP requirements for employees' “personal hygiene”? How should they be reflected in SOPs?
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.
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