HONG KONG DRUG LICENSING
Hong Kong Drug Licence FAQs
Search 500 Hong Kong drug licence FAQs on applications, personnel, premises, quality systems, ongoing regulation, renewals and acquisitions.
Information status: The original FAQ material dates from 2025 and is provided for topic-based reference; it does not represent an individual verification of all 500 FAQs against current rules. For application, fee, renewal, change, product or prescription requirements, please refer to the current official forms and guidance.
Official information from the Drug Office Official information from the Chinese Medicines Board
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Q316 · 如何制定和执行一份有效的仓库清洁与卫生（Cleaning and Sanitation）SOP？独立链接
Keeping the warehouse clean and hygienic is fundamental to preventing cross-contamination of medicines and ensuring appropriate storage conditions. An effective cleaning SOP should be highly practical. It should clearly specify: 1. The scope of cleaning: all areas, including floors, shelving, walls, ceilings and equipment surfaces; 2. Cleaning frequency: for example, floors daily and shelving weekly; 3. Cleaning tools and agents: specific types must be identified, and these materials must not contaminate medicines; 4. Detailed cleaning methods and steps: for example, working from top to bottom and from inside to outside; 5. Post-cleaning inspection criteria: achieving a “visibly clean” standard; 6. Cleaning records: a designated person should complete a cleaning log recording the date, time, person carrying out the cleaning and person inspecting it. There should also be a specific procedure for dealing with accidental spills, such as leakage from damaged medicines.
Q317 · 当客户退回药品时，我应该如何处理？退回的药品可以重新销售吗？独立链接
Returns are a high-risk area and must be governed by a strict SOP. First, all returned drugs must be identified immediately and quarantined in a dedicated, secure returns area to prevent them from inadvertently re-entering saleable stock. An authorised member of the quality department must then carefully assess the returned drugs to determine their final disposition. Only if very strict conditions are met may drugs be considered for return to saleable stock. These conditions include the drugs remaining in their original, unopened packaging; storage conditions having been maintained throughout (for example, with evidence that the cold chain was not interrupted); sufficient remaining shelf life; and inspection and approval by a qualified person. Any drugs that do not meet these conditions must be destroyed.
Q325 · 在GDP中，“验证”（Validation）和“确认”（Qualification）有何区别？哪些系统或设备需要做？独立链接
“Qualification” and “validation” both demonstrate that a system, equipment or process can consistently achieve its intended results, but they have different emphases. “Qualification” is usually applied to equipment, facilities and systems. It demonstrates that the “hardware” itself has been installed correctly, operates correctly and is suitable for its intended use. It usually comprises four stages: design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). Qualification of a new refrigerator is one example. “Validation” focuses more on the “process”: it demonstrates that a complete process or method can consistently produce results that meet predetermined standards. Examples include transport validation of a cold-chain packaging solution and validation of a computerised system. In short, qualification is the foundation for validation: equipment is usually qualified first, followed by validation of the processes that use it.
Q326 · 什么是“校准”（Calibration）？哪些仪器设备必须进行校准，频率如何？独立链接
Calibration is the process of comparing the reading of a measuring instrument, such as a thermometer, hygrometer or weighing scale, with a recognised, more accurate standard traceable to international or national standards, in order to determine and record its accuracy. If a deviation beyond the acceptable range is found, the instrument must be adjusted or replaced. In the wholesale of medicines, all instruments used to monitor and control critical parameters that affect medicine quality must be calibrated regularly. These include all probes used to monitor temperature and humidity in warehouses and refrigerators, temperature loggers used in cold-chain transport, and electronic scales used to weigh medicines. Calibration ensures that the data on which you rely to make quality decisions is accurate and reliable.
Q330 · 我的QMS中是否需要包含业务连续性计划（BCP）或应急计划？独立链接
Yes, a mature QMS should include a Business Continuity Plan (BCP) to address unexpected events that may interrupt your critical operations. Such events may include natural disasters (such as a typhoon causing a power failure), fire, serious IT system failures, the collapse of a key supplier or the warehouse becoming unusable. The core purpose of a BCP is to identify these risks in advance and establish an action plan to ensure that critical products and services can continue to be provided at a predetermined, acceptable level during a crisis. This is particularly important for medicine wholesalers, as an interruption to medicine supply may directly affect patient treatment. The plan should include an emergency command structure, internal and external communication arrangements, data backup and recovery procedures, and arrangements for alternative facilities or suppliers.
Q335 · GDP对员工的“个人卫生”（Personal Hygiene）有哪些具体要求？应如何体现在SOP中？独立链接
Although pharmaceutical wholesale does not have the extreme environmental requirements of sterile manufacturing, good personal hygiene remains a basic element in preventing medicine contamination. GDP requires companies to establish and implement relevant hygiene procedures. Your hygiene SOP should specify that: 1. All employees entering medicine storage and handling areas must wear clean work clothes; 2. Hands must be cleaned appropriately before handling medicines; 3. Employees who have an infectious disease that could contaminate medicines or open skin wounds must report it to a supervisor immediately and be temporarily removed from duties involving direct contact with medicines; 4. Eating, drinking, smoking or keeping personal food and belongings in medicine storage and handling areas is strictly prohibited; and 5. Personal clothing must be kept clean. These requirements are intended to minimise the risk of medicine contamination from human factors.
Q343 · 为确保库存准确和防止混淆，有哪些库存管理的最佳实践？独立链接
Accurate inventory management is the foundation of GDP, and is key to effective traceability and error prevention. Best practices include: 1. **Clear location management**: Assign a unique code to every shelf, level and location in the warehouse, and link product information to the location code in the system. 2. **Status segregation**: Strictly separate inventory with different statuses, both physically and in the system, such as “released goods”, “quarantined goods pending examination”, “returned goods” and “non-conforming goods / goods pending destruction”, and use clear signs to identify each area. 3. **First in, first out / first expiry, first out (FEFO)**: Your Warehouse Management System (WMS) should support the FEFO principle to ensure that products with the earliest expiry dates are dispatched first. 4. **Cycle counting**: Replace the traditional annual full stocktake with ongoing counts of a small proportion of inventory daily or weekly. This helps identify and correct discrepancies earlier, keeping system data accurate. 5. **Batch-level management**: All inventory operations must be managed at batch level to ensure that the movement of every product batch is recorded accurately.
Q344 · 用于GDP活动中的计算机化系统（如WMS, ERP）需要满足哪些验证和管理要求？独立链接
Computerised systems used to manage critical GDP activities (such as warehouse management systems (WMS), enterprise resource planning systems (ERP) and temperature and humidity monitoring systems) must themselves be controlled to ensure that the data they generate are reliable, accurate and secure. These systems require Computer System Validation (CSV), with documented evidence demonstrating that they consistently meet their intended functions and regulatory requirements throughout their lifecycle. CSV generally follows the GAMP 5 (A Risk-Based Approach to Compliant GxP Computerized Systems) framework. Key management requirements include: 1. **Data integrity**: the system must be designed to ensure compliance with the ALCOA+ principles; 2. **Audit trail**: the system must automatically record all activities relating to the creation, modification and deletion of GxP data, including timestamps and operator information; 3. **Access controls**: grant users the minimum system access necessary for their roles and responsibilities; 4. **Backup and recovery**: validated procedures must be in place to back up data regularly and restore it reliably when required; 5. **Change control**: any changes to the system (such as software upgrades or configuration changes) must be managed through a formal change control procedure.
Q346 · 在设计或改造药品仓库时，有哪些关键的GDP布局要求需要考虑？独立链接
The core design principles for a GDP-compliant warehouse layout are to ensure clear goods flows, prevent mix-ups and cross-contamination, and provide suitable storage conditions. Key layout requirements include: 1. **Functional zoning**: clearly separate, physically or by other effective means, areas such as goods receipt, quarantine pending examination, storage of released goods, non-conforming goods, returns, recalled goods and dispatch. 2. **One-way flow**: design sensible goods-flow routes so that, as far as possible, medicines move in one direction from receipt to dispatch, avoiding unnecessary backtracking and crossovers. 3. **Adequate space**: ensure that all areas have enough space for orderly storage and operations, avoiding excessive stacking or blocked passageways. 4. **Environmental controls**: areas requiring special storage conditions, such as refrigeration, protection from light or ventilation, should be specifically designed and equipped with suitable facilities. 5. **Security**: offices, rest areas and other non-operational areas should be separated from medicine storage areas. Storage areas for controlled medicines require additional security measures.
Q349 · 一份详尽的内部审核（自我检查）报告应包含哪些内容？独立链接
An internal audit report is a key document for recording audit findings and driving subsequent improvements; its quality directly affects the effectiveness of the audit. A detailed report should be clearly structured and specific. It should include at least the following sections: 1. **Basic information**: unique audit reference, audit date, scope (such as “storage operations” or “document system”), audit criteria (such as GDP guidance or company SOPs), auditor’s name and the department audited. 2. **Audit summary**: a brief overview of the audit and its main conclusions. 3. **Audit findings**: the core of the report. Clearly list each non-conformity (deficiency) separately. Describe the specific facts observed in detail (“where I was and what I saw”) and cite the specific legislative or SOP provision breached. 4. **Deficiency grading**: grade each deficiency according to its potential impact on product quality and regulatory compliance (for example, “critical”, “major” or “minor”). 5. **Recommendations (optional)**: the auditor may suggest improvements, but the audited department should determine the final corrective actions. 6. **Report distribution list and conclusion**.
Q352 · 卫生署药物办公室进行例行视察时，通常会重点检查哪些方面？我们应该如何准备？独立链接
Routine inspections by the Department of Health are intended to ensure that licence holders continue to comply with the relevant legislation and codes of practice. Inspections are usually unannounced, although advance notice may also be given. The main areas checked include: 1. Premises and facilities: whether they meet the standards set at the time of licensing, particularly whether the warehouse environment for medicine storage meets the requirements. 2. Documents and records: the main focus of the inspection, including records of medicine purchases, sales and stock, as well as temperature monitoring and staff training records. 3. Operation of the Quality Management System: inspectors will sample-check whether your Standard Operating Procedures (SOPs) are being implemented effectively. 4. Personnel qualifications and responsibilities: ensuring that personnel in key roles have the relevant qualifications and clearly understand their responsibilities. To prepare, ensure all documents and records are well organised and readily accessible, and provide staff with regular training and mock inspection exercises so they can remain composed and answer questions accurately during an inspection.
Q359 · 在药品库存管理方面，除了保证先进先出，还有哪些关键的合规要点？独立链接
Effective inventory management is central to ensuring medicine quality and safety. In addition to strictly applying the “first-expired-first-out” (FEFO) principle (that is, dispatching items with the earliest expiry date first, which is more accurate than FIFO), the following key compliance points apply: 1. Clear zoning: the warehouse must have clearly designated areas for quarantined goods pending examination, released goods, non-conforming goods, returned goods and recalled goods, with clear signs to distinguish them and prevent mix-ups and cross-contamination. 2. Environmental monitoring: medicines with specific temperature and humidity requirements must be monitored and recorded continuously, 24 hours a day, using calibrated equipment. There must be an emergency plan for environmental excursions, and actions taken must be documented. 3. Regular stocktakes: stock must be counted regularly, and physical inventory reconciled against stock records. Any discrepancies must be investigated and documented. 4. Expiry-date management: establish an expiry-date alert system and closely monitor medicines approaching their expiry date to prevent expired medicines from being dispatched accidentally. 5. Security: take appropriate security measures to prevent unauthorised access to storage areas and prevent medicines from being stolen or tampered with.
Q371 · 我们的药品仓库应该如何进行有效的虫害控制？独立链接
Effective pest control is essential for preventing contamination of medicines and maintaining hygienic storage conditions. You need to establish a comprehensive pest management programme. This involves more than simply placing a few mousetraps. The programme should include: 1. Prevention measures, which are the most important part. These include maintaining the building structure in good condition, sealing all potential pest entry routes (such as holes in walls and gaps around doors and windows), keeping the premises and surrounding area clean, and eliminating food sources and standing water. 2. Inspection and monitoring: inspections should be carried out regularly by trained personnel or a professional pest control company, and monitoring devices (such as glue boards and mousetraps) should be placed at key locations (such as entrances and corners), with their locations shown on a plan. 3. Treatment and reporting: if pest activity is detected, appropriate measures that will not contaminate medicines must be taken immediately and documented. Detailed records of all inspection, monitoring and treatment activities must include the date, findings, actions taken and the person responsible.
Q372 · 什么是仓库的“温度图谱研究”（Temperature Mapping Study）？我们必须做吗？独立链接
A temperature mapping study (also known as temperature distribution validation) is a scientific validation exercise. It involves placing sufficient temperature probes at different locations within a warehouse or cold room, including high, low and middle positions and locations near doors, windows and air-conditioning outlets, and continuously recording data over a period of time (usually 7 consecutive days, covering the hottest and coldest seasons). The aim is to identify the hottest and coldest points in the warehouse and demonstrate that temperatures throughout the storage space can be maintained consistently within the specified range, such as 15–25°C or 2–8°C. For all pharmaceutical wholesalers and manufacturers requiring temperature-controlled storage, temperature mapping studies are a mandatory GDP/GMP requirement. They form the basis for demonstrating that your storage facilities can continuously safeguard medicine quality.
Q384 · 如果我们的仓库温控空调系统在夜间发生故障，导致温度超出范围，我们该怎么办？独立链接
This is an emergency that must be handled immediately and systematically. First, once the fault is detected through the alarm system, send someone to the site immediately to assess the situation and arrange repairs as soon as possible. Second, record the incident immediately as a “deviation”, noting when the fault occurred, when the temperature first went out of range, the highest temperature reading, and the affected areas and medicines. Third, immediately quarantine all affected medicines in the “quarantined goods pending examination” area and label them clearly. They must not be dispatched under any circumstances. Fourth, contact the manufacturer of the medicines concerned or consult their stability data to assess the specific impact of this brief temperature excursion on medicine quality. Some medicines may tolerate short-term temperature fluctuations for a certain period, while others are highly sensitive. Finally, the medicines may be considered for release again only after a written assessment from the manufacturer confirms that their quality has not been affected. Otherwise, they must be destroyed in accordance with the procedure. The entire process must be fully documented.
Q387 · 对于退回、拒收或召回的药品，具体的记录和管理要求是什么？独立链接
Managing returned, rejected and recalled medicines is a key control point for preventing non-conforming goods from re-entering the market. You must establish strict procedures and a record system. First, all such medicines must be immediately segregated in a dedicated, secure, clearly identified physical area and must not be mixed with released goods. Second, every return, rejection or recall must be documented in detail, including the medicine name, batch number, quantity, source (customer), reason and date received. Third, the quality department must assess the medicines and decide on their final disposition. There are only three possible outcomes: a) if it can be confirmed that the medicine’s quality has not been affected (for example, it was simply sent in error and transport conditions were controlled throughout), it may be returned to stock with approval from the head of the quality department; b) if it needs to be destroyed, follow the destruction procedure; or c) if it has been recalled, handle it in accordance with the recall plan. All assessments, decisions and final disposition actions must be documented.
Q388 · 我们应该如何校准我们的关键测量设备，例如仓库的温度探头和实验室的电子天平？独立链接
Equipment calibration is fundamental to ensuring that measurement data is accurate and reliable, and is a prerequisite for data integrity. You must establish a calibration programme for all critical equipment that affects the quality of medicines. The programme should include: 1. Equipment list: list all equipment requiring calibration. 2. Calibration frequency: set a reasonable calibration interval according to the importance and stability of the equipment (for example, calibrate temperature probes annually and electronic balances quarterly). 3. Calibration method: specify the standards and procedures used for calibration. Calibration must be traceable; the standards used for calibration must themselves be traceable to higher-level national or international standards. 4. Implementation and records: calibration may be carried out by competent internal personnel or outsourced to a qualified external organisation (such as a HOKLAS-accredited laboratory). Each calibration must be documented in detail in a calibration certificate, including readings before and after calibration, whether the equipment passed, and the name of the person performing it and the date. All calibrated equipment should be labelled with the date of the latest calibration and the date of the next calibration.
Q391 · 我们的年度自检（Self-Inspection）应该由谁来执行才能保证其客观性？独立链接
The purpose of annual self-inspection is to conduct a critical and honest assessment of your own Quality Management System, so objectivity and independence are essential. To ensure this, the people or team conducting the self-inspection should be as independent as possible from the activities being inspected. Best practice is to: 1. Form a self-inspection team with members from different departments—for example, have production staff inspect the warehouse and warehouse staff inspect the quality control laboratory, creating cross-checks. 2. Appoint a member of management who is not directly responsible for specific operations, such as the quality assurance manager, to lead the team. 3. If the company’s size and resources permit, engage an independent external consultant or auditor to conduct the self-inspection. This can provide the most objective perspective and may bring experience of industry best practices. Regardless of who conducts it, self-inspection personnel must receive appropriate training and be familiar with GDP/GMP requirements and auditing techniques.
Q420 · 我们仓库里有一批过期的药品，应该如何处理？可以直接当垃圾丢弃吗？独立链接
Absolutely not. Expired medicines must not be discarded as ordinary rubbish. They are subject to strict disposal requirements to prevent them from re-entering the market or polluting the environment. As a licensed wholesaler or manufacturer, you must establish a formal medicine destruction procedure. First, isolate the expired medicines and label them clearly. Then engage a qualified chemical waste collector to handle them. Detailed records of the entire destruction process must be kept, including the medicine name, batch number, quantity, destruction date and method. At least two staff members, one of whom should be a manager, must jointly supervise and sign to confirm the process. These records must be available for inspection, and the Department of Health may request them during an inspection.
Q437 · 我是否可以将药品存放在持牌地址以外的地方，例如迷你仓？独立链接
Absolutely not. Under Hong Kong law, all regulated medicines, whether Western medicines or proprietary Chinese medicines, must be stored at licensed premises specified on the licence and approved by the regulatory authority. The facilities at these premises, including temperature and humidity controls, security systems and fire prevention measures, are subject to rigorous scrutiny to ensure the quality and safety of the medicines. Unapproved external storage locations, such as offices, homes or mini-storage units, do not meet statutory storage requirements. Storing medicines at these locations is a serious breach.