Q195 · Does a dedicated area need to be designated…

Q195 · Category D: Premises and Storage Requirements (Q151-Q200)

Yes, if your business involves sampling medicines for quality control, you must set up a dedicated, environmentally controlled sampling room or booth (Sampling Booth/Room). Sampling is a high-risk operation because it requires the original medicine packaging to be opened, creating a high risk of microbial or cross-contamination. The design and management of the sampling room must therefore be very stringent. Ideally, it should be a laminar-flow cabinet fitted with a high-efficiency particulate air filter (HEPA filter), or a separate cleanroom, to provide a sterile or low-dust working environment. Personnel entering the sampling room must wear clean workwear, gloves and masks. All sampling tools must be sterile and used for only one batch per sampling operation. The entire sampling process must be guided by detailed SOPs and recorded.

📘 Regulatory basis

Sampling falls within the scope of Good Manufacturing Practice (GMP) because it directly affects product quality. GMP sets out detailed requirements for the sampling environment, personnel and procedures, with the aim of “preventing contamination and cross-contamination during sampling”.

📗 Drew Tang's recommendations

For most pharmaceutical wholesalers, their business does not involve sampling finished medicines in sealed packaging. Sampling usually takes place during medicine manufacture or the acceptance of raw materials. If you only distribute finished products, you will generally not need a sampling room. However, if you need to open packages for any form of inspection beyond visual inspection, we strongly recommend seeking our advice first to determine whether this would be considered sampling requiring GMP-level controls.

📕 Risk notice

Opening medicine packaging or taking samples for ‘inspection’ in an ordinary warehouse environment is strictly prohibited and constitutes a serious breach. This directly compromises the sterility or integrity of the medicine, making it unsuitable for sale. If the Drug Office discovers this, the batch will be regarded as contaminated, and your company may be investigated for suspected unlawful ‘manufacturing’ because the product’s condition has been altered.

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.

Does a dedicated area need to be designated in the warehouse for medicine sampling?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang