Q172 · Do separate changing rooms, toilets and rest…

Q172 · Category D: Premises and Storage Requirements (Q151-Q200)

Yes, providing appropriate hygiene and rest facilities for employees is one of the requirements of Good Distribution Practice. The aim is to protect staff health and prevent medicines from being contaminated due to personal hygiene issues. The premises should have a sufficient number of clean, hygienic toilets. Toilets should be equipped with hand soap and hand-drying facilities (such as a hand dryer or paper towels), and display “Please wash your hands” notices. If employees need to wear workwear or protective clothing for their duties, a separate changing room should be provided for storing personal clothing and workwear to prevent cross-contamination. A rest area or pantry, separate from medicine storage and handling areas, should also be provided for employees to eat, drink and rest. Eating, drinking or storing food in medicine storage or handling areas is strictly prohibited, to avoid attracting pests and causing contamination.

📘 Regulatory basis

The Good Distribution Practice (GDP) states: “Storage areas should not contain toilets, showers or catering facilities. These facilities should be separate from the storage area but readily accessible to staff.” This clearly establishes the principle of functional separation.

📗 Drew Tang's recommendations

We recommend that clients design the premises layout so that staff facilities (toilets and rest areas) and core medicines handling areas (warehouse and work areas) have separate routes, minimising unnecessary movement through core areas. Installing a shoe-cover dispenser or tacky mat at the entrance to the rest area is also a good practice for strengthening hygiene controls.

📕 Risk notice

During a Department of Health inspection, finding employees’ lunch boxes or drinking cups beside medicine shelves, or food residue on workbenches, would constitute a serious hygiene deficiency. This not only reflects inadequate staff training but also exposes major management failures and may create a direct risk of medicine contamination, affecting the licence application.

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.

Do separate changing rooms, toilets and rest areas need to be provided for staff at the premises?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang