Q185 · Do I need to prepare a Standard Operating…

Q185 · Category D: Premises and Storage Requirements (Q151-Q200)

Yes, in principle, all critical equipment that affects medicine quality, staff safety or operational compliance should have a corresponding Standard Operating Procedure (SOP). The purpose of an SOP is to ensure that equipment is used, maintained and managed correctly and consistently, thereby reducing the risk of human error and equipment failure. Equipment for which SOPs are usually required includes: 1. **Environmental monitoring equipment**: for example, an SOP for a temperature and humidity monitoring system should cover how to read data, respond to alarms and carry out routine checks. 2. **Storage equipment**: an SOP for cold rooms and refrigerators should cover start-up and shutdown, defrosting, cleaning and emergency response. 3. **Handling equipment**: for example, SOPs for forklifts and pallet trucks should cover routine safety checks, operating procedures, charging/refuelling and maintenance. 4. **Measuring equipment**: an SOP for an electronic weighing scale should cover routine calibration checks (using standard weights) and cleaning. 5. **Security equipment**: SOPs for CCTV and alarm systems should cover arming and disarming the systems and retrieving footage.

📘 Regulatory basis

Good Distribution Practice (GDP) requires “written procedures for the operation, cleaning and maintenance of critical equipment that may affect the quality of medicines”. This makes clear the need to establish SOPs for critical equipment.

📗 Drew Tang's recommendations

SOPs should not be complex, difficult-to-understand lengthy documents. We recommend that clients prepare a concise “operating instruction card” for each piece of equipment, with text and illustrations, and display it beside the equipment for operators to consult at any time. The full SOP should be retained as a formal document for training and audits. For example, the SOP for a temperature and humidity meter can be very simple, but it must exist.

📕 Risk notice

During an inspection, if an officer points to a key piece of equipment and asks the operator how to use it, but the operator cannot answer, or the officer asks to see the equipment’s SOP and you cannot provide it, this will indicate serious deficiencies in your documentation system and training. The officer may question your ability to manage your facilities in a controlled manner.

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 I need to prepare a Standard Operating Procedure (SOP) for every piece of equipment in the warehouse, such as forklifts and temperature and humidity meters?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang