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How can we ensure that employees comply with personal hygiene (Personal Hygiene) requirements in their daily work?

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

Q395 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)
Good personal hygiene is the first line of defence against contamination of medicines, particularly microbial contamination, and is emphasised in both GMP and GDP. To ensure staff comply, you should: 1. Establish clear SOPs: Create an SOP on personal hygiene specifying that staff must wash their hands and wear designated clean work clothing, footwear, hairnets and masks before entering areas where medicines are handled. The SOP should also prohibit eating, drinking, smoking and chewing gum in work areas, and prohibit wearing jewellery that could come loose. 2. Provide facilities and supplies: The company must provide adequate handwashing facilities, disinfectant and clean, well-fitting work clothing. 3. Provide training: All staff, including temporary workers and visitors, must receive training on personal hygiene requirements before entering work areas. Training should be repeated regularly to reinforce awareness. 4. Supervision and enforcement: Supervisors and quality personnel should monitor compliance with personal hygiene requirements during day-to-day work and correct any breaches. 5. Health management: Require staff to report to their supervisor if they are ill or have open skin wounds, and temporarily reassign them from roles involving direct contact with medicines.

📘 Regulatory basis

Chapter 2, “Personnel”, of the PIC/S GMP Guide and the Drug Wholesalers Code of Practice both set out clear and detailed personal hygiene requirements, treating them as part of personnel qualifications.

📗 Drew Tang's recommendations

We recommend making personal hygiene requirements the first topic in new employee induction training. Illustrated reminder posters displayed in changing rooms and at entrances to work areas can be effective prompts. Management should lead by example and observe the same hygiene standards; this is essential to building a good hygiene culture.

📕 Risk notice

Poor personal hygiene is a major source of microbial contamination. In high-risk areas such as aseptic production, staff negligence may contaminate an entire batch, causing substantial losses and safety risks. If inspectors observe that staff generally fail to comply with personal hygiene requirements during a Department of Health inspection, this will be regarded as direct evidence of management shortcomings and inadequate training, and is a serious deficiency.

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