Establishing a compliant cleaning and disinfection procedure is fundamental to maintaining hygiene in the medicine storage environment. The procedure must be a written Standard Operating Procedure (SOP) and should include: 1. Scope of cleaning, covering all areas, including floors, walls, shelving and equipment. 2. Cleaning frequency, which may vary between areas—for example, daily cleaning of operational areas and weekly or monthly cleaning of high shelving. 3. Cleaning agents and disinfectants used, specifying the product name, concentration and method of use, and ensuring they will not contaminate medicines. 4. Cleaning tools, specifying dedicated tools (such as mops and cloths) and how they are to be cleaned and stored after use to prevent cross-contamination. 5. Cleaning methods, describing the operating steps in detail. 6. Record-keeping requirements: after each cleaning, the responsible person must sign and date the Cleaning Record Form. The disinfection procedure should be implemented when necessary, such as after a spillage or contamination incident, and documented in the same detail.
HONG KONG DRUG LICENSING
How should cleaning and disinfection procedures for a medicine warehouse be developed and documented to meet GDP requirements?
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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