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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Thematic illustration for pharmaceutical licensing business queries and document organisation services — Discuss actual operating questions one-to-one to clarify the next decision.

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.

📘 Regulatory basis

Both the Code of Practice for Licensed Wholesale Dealers and GMP guidance set out clear requirements for the hygiene conditions of premises, emphasising that measures must be taken to prevent insects, rodents and other animals from entering and contaminating medicines.

📗 Drew Tang's recommendations

We recommend that clients enter into an annual service contract with a reputable specialist pest control company experienced in handling pharmaceutical or food warehouses. As well as providing professional services, it can provide complete reports and trend analyses that meet regulatory requirements. When selecting insecticides or rodenticides, ensure that they are approved for use and will not pose a contamination risk to medicines.

📕 Risk notice

Signs of pests (such as droppings or gnaw marks) are among the “critical defects” that Department of Health inspectors pay close attention to. If pest activity is found in a drug storage area, all drugs in that area may be deemed contaminated and need to be quarantined and destroyed. This is not only a financial loss but also a serious blow to your Quality Management System.

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.

📘 Regulatory basis

Both the Code of Practice for Licensed Wholesale Dealers and the PIC/S GDP/GMP guidelines expressly require temperature mapping studies to be conducted before a new temperature-controlled storage area is brought into use, to confirm its performance. Revalidation is required after major refurbishment.

📗 Drew Tang's recommendations

We recommend outsourcing temperature mapping studies to a specialist validation service provider. On completion of the study, you will receive a detailed report. This report should guide you to place routine monitoring probes at the “worst-case” locations identified by the study (the hottest and coldest points), because if these locations meet requirements, the temperatures in other areas are likely to meet them too. The study should be repeated periodically (for example, every 3 years) or whenever there is a major change to the warehouse layout.

📕 Risk notice

Without a temperature mapping study, or if the study is not properly conducted, you cannot scientifically demonstrate that your warehouse meets temperature-control requirements. This will be regarded as a major deficiency during a Department of Health inspection. If your routine temperature-monitoring probe happens to be placed in the “good” location where the temperature is most stable, while the hottest spot has already exceeded limits, all your temperature records may be invalid and the quality of the medicines stored may be at serious risk.

Q373 · 当收到客户关于药品质量的投诉时，我们应该如何处理？独立链接

Customer complaints are an important part of the Quality Management System and must be handled seriously and systematically. The standard process is as follows: 1. Record the details: regardless of the channel through which the complaint is received (telephone, email or in person), create a formal complaint record immediately, setting out in detail the complainant’s information, drug name, batch number and specific complaint (such as damaged packaging, unusual colour or foreign matter). 2. Initial assessment: a designated person (usually from the quality department) conducts an initial assessment of the seriousness of the complaint. If a potentially serious safety risk is involved, immediate quarantine of the relevant batch may need to be considered. 3. Investigation: investigate the complaint thoroughly. This may include checking retained samples from the same batch, reviewing production or distribution records, and interviewing relevant personnel to identify the root cause. 4. Take action and respond: take appropriate corrective and preventive action (CAPA) based on the investigation findings. A formal written response must also be provided to the customer within a reasonable time, setting out the investigation findings and the actions the company will take. The entire process must be fully documented.

📘 Regulatory basis

Both the Code of Practice for Licensed Wholesale Dealers and GMP guidance require licensees to establish written procedures for handling complaints, investigate and record all complaints, and take measures to prevent recurrence.

📗 Drew Tang's recommendations

Treat every complaint as a free opportunity for quality improvement. We recommend classifying and analysing trends across all complaints. For example, frequent complaints about damaged packaging for a particular product may indicate a need to review the packaging materials or transport process. Establishing a cross-departmental complaint investigation team can provide a more comprehensive analysis. A prompt, transparent and professional response to customers can sometimes turn a negative incident into an opportunity to build customer trust.

📕 Risk notice

Ignoring quality complaints or handling them improperly is a serious failure in the eyes of the regulatory authorities. If a customer escalates a complaint to the Department of Health after not receiving a satisfactory response, and you cannot provide complete internal investigation records, you will be in a very difficult position. If several complaints point to the same potential quality defect and you fail to identify and address it promptly, you may face more severe penalties if this leads to a serious incident such as a recall.

Q374 · 法规要求记录至少保存两年，我们是否有必要保存更长时间？独立链接

The statutory “at least two years” is a minimum requirement. In practice, however, many companies choose to retain key records for longer as a matter of prudence and risk management. For example, a widely accepted best practice for batch manufacturing and distribution records is to retain them until at least one year after the expiry date of the medicine. This means that if a quality issue or adverse reaction report is identified shortly before or after the medicine expires, you can still trace the complete manufacturing and distribution history for investigation. For some records relating to company operations, validation or critical equipment (such as validation reports, training records for key personnel and change control records), permanent retention is recommended, or at least retention for a substantial period after the relevant system or equipment has been decommissioned.

📘 Regulatory basis

The Pharmacy and Poisons Regulations (Cap. 138A) require records of poison purchases and sales to be retained for at least two years. The Code of Practice for Wholesale Dealers in Poisons also generally adopts this minimum standard. GMP guidelines, however, usually recommend a longer retention period.

📗 Drew Tang's recommendations

We recommend that clients establish a clear Document Retention Policy, setting different retention periods according to the nature and importance of different records rather than applying one rule to all. For example, financial records may need to be retained for 7 years under tax regulations, while batch records may follow the “expiry date + 1 year” rule. For electronic records, ensure their readability and integrity throughout the retention period, taking account of compatibility issues caused by technological changes.

📕 Risk notice

Meeting only the minimum two-year requirement may put you at a disadvantage in certain circumstances. For example, if an issue is discovered with a medicine having a three-year shelf life two and a half years after it was placed on the market, and you have already destroyed the relevant records, you will be unable to investigate effectively or defend yourself in legal proceedings. Destroying records too early is effectively destroying evidence that could protect you.

Q375 · 在日常操作中如果发生了“偏差”（Deviation），我们应该如何处理？独立链接

A “deviation” is any event in which approved instructions or an established Standard Operating Procedure (SOP) is not followed. All deviations, whether planned or accidental, must be formally managed and addressed. The correct procedure is: 1. Report and record immediately: any employee who identifies a deviation is responsible for reporting it promptly to their supervisor and the quality department. A deviation report must be created immediately, detailing when and where the event occurred, the personnel and materials involved, and how the SOP was not followed. 2. Assess the impact: the quality department must promptly assess the potential impact of the deviation on product quality, safety and efficacy. If the impact is serious, the relevant batches may need to be quarantined and release suspended. 3. Investigate the root cause: investigate the cause thoroughly, rather than stopping at “human error”. Examine whether the process was poorly designed, training was inadequate or there was an equipment problem. 4. Establish CAPA: develop and implement effective corrective and preventive action (CAPA) based on the root cause. 5. Close the deviation: after the investigation and corrective actions are complete, the quality department reviews and formally closes the deviation report.

📘 Regulatory basis

The core principle of GMP and GDP is to operate in accordance with established procedures. Deviation management is therefore a key element of the quality management system. Chapter 1 of the PIC/S GMP Guide emphasises the requirements for recording, investigating and handling deviations.

📗 Drew Tang's recommendations

We encourage clients to establish a “blame-free” reporting culture that encourages employees to report deviations proactively rather than conceal them. Treat deviation management as a tool for continual improvement. Regular trend analysis of deviations can help identify systemic weaknesses. For example, frequent deviations in a particular role may indicate that the relevant SOP is too complex or impractical and needs revision.

📕 Risk notice

Failing to report, investigate or document deviations is a serious data integrity issue and a “critical deficiency” in regulatory inspections. It indicates that your quality system is out of control. An unevaluated deviation may conceal a significant product quality risk. If a concealed deviation leads to a product recall, the consequences will be disastrous.

Q376 · 我们应该如何对我们的药品或原材料供应商进行资格认证和管理？独立链接

Supplier management is key to ensuring quality at the start of the supply chain. You should not choose a supplier solely because of its low prices. A sound supplier management procedure should include: 1. Initial assessment and selection: before choosing a new supplier, you must assess its qualifications. This may be done through questionnaires, by requesting evidence of qualifications (such as a manufacturing licence or GMP certificate), or by conducting an on-site audit. Assess its quality management system, manufacturing capacity, compliance history and other relevant factors. 2. Approval and agreements: only suppliers that have passed the assessment may be added to the Approved Supplier List. For suppliers of critical materials, a Quality Agreement should also be signed to define the quality responsibilities of both parties. 3. Ongoing monitoring: continuously monitor supplier performance, for example through indicators such as the acceptance rate of incoming goods, on-time delivery and response times to complaints. 4. Periodic reassessment: reassess suppliers periodically (for example, every 1–3 years, depending on risk level) to ensure that they continue to meet your requirements. Suppliers with serious quality issues or consistently poor performance should be removed from the Approved Supplier List.

📘 Regulatory basis

Both the Code of Practice for Licensed Wholesale Dealers and GMP guidance require licensees to ensure that they procure medicines or raw materials only from approved suppliers, and to have procedures for supplier qualification and management.

📗 Drew Tang's recommendations

We recommend classifying suppliers by risk. On-site audits are almost essential for suppliers of key active pharmaceutical ingredients (APIs). Suppliers of lower-risk materials, such as packaging materials, can be assessed through document review. Do not rely entirely on suppliers’ GMP certificates; particularly in high-risk areas, conducting an audit yourself or commissioning a third party to do so will give you a more accurate understanding. Rengangyongsheng (Hong Kong) Limited provides professional supplier audit services.

📕 Risk notice

Purchasing medicines or raw materials from unapproved suppliers is a serious GDP/GMP breach. It compromises the assurance of product origin and prevents effective traceability. If a supplier’s materials have quality issues that result in non-conforming finished products, you will bear full responsibility. In the eyes of regulators, selecting an unqualified supplier is equivalent to deliberately introducing risk into your system.

Q377 · 对于需要冷链运输的药品，我们如何确保运输过程中的温度合规？独立链接

Ensuring compliant transport temperatures for cold-chain medicines requires a systematic approach to validation and monitoring. First, you need to conduct “transport validation”. This means demonstrating that your chosen transport route, packaging solution (such as insulated boxes and ice packs) and transport equipment can keep the medicines within the specified temperature range, usually 2–8°C, even under worst-case conditions, such as the hottest summer weather and the longest transport time. This is usually done by placing multiple temperature loggers inside the transport containers and conducting actual or simulated transport. Second, a calibrated, independent temperature logger must be used to monitor the goods’ temperature throughout every actual shipment. On receipt, the recipient must check the temperature records immediately and may accept the goods only after confirming that the temperature remained within range throughout. Any temperature excursion must be investigated as a deviation.

📘 Regulatory basis

Both the Code of Practice for Licensed Wholesale Dealers and the PIC/S GDP guidelines set very high standards for the transportation of cold-chain medicines, emphasising that transport conditions must be validated and monitored to ensure that medicine quality is not affected during transportation.

📗 Drew Tang's recommendations

We recommend that clients use a “qualified” cold-chain packaging solution that has been validated in advance. Many specialist suppliers on the market provide such services. When working with a transport company, its responsibilities for cold-chain transport must be clearly specified in the contract or quality agreement. It is equally important to provide dedicated training for drivers so that they understand the importance of cold-chain medicines and the emergency procedures to follow in the event of an incident (such as vehicle failure).

📕 Risk notice

Cold-chain interruptions are one of the main causes of failure of medicines such as costly biological products. A single temperature excursion may mean that medicines worth millions must be destroyed. If cold-chain medicines are transported without transport validation or continuous temperature monitoring, the Department of Health may treat this as a critical deficiency if discovered, because you would be completely unable to demonstrate that the medicines were in acceptable condition when delivered to the customer.

Q378 · 什么是“变更控制”（Change Control）系统？为什么它如此重要？独立链接

“Change control” is a formal, systematic process for managing any changes that could affect the quality, safety, efficacy or compliance of medicines. Such changes may include changes to manufacturing processes, replacement of raw material suppliers, updates to analytical methods, upgrades to critical equipment, revisions to Standard Operating Procedures (SOPs), and even alterations to factory facilities. The change control process requires every planned change to be reviewed and approved by a cross-functional assessment team (usually including representatives from production, quality and regulatory affairs) before implementation. The purpose of the assessment is to analyse comprehensively the potential impact and risks of the change and determine the measures required (such as revalidation or notification of the regulatory authority) to ensure that the system remains under control after the change. The application, assessment, approval and implementation of all changes must be fully documented.

📘 Regulatory basis

Both GMP and GDP systems treat change control as one of their cornerstones. Chapters 1 and 5 of the PIC/S GMP Guide set out in detail the requirements for formal assessment and approval of changes.

📗 Drew Tang's recommendations

We recommend that clients embed change control in the company culture: apply for approval before implementing any change, however small. An electronic change control system can greatly improve process efficiency and transparency. Ongoing staff training to help them understand the potentially disastrous consequences of unapproved changes is key to successful change control.

📕 Risk notice

Uncontrolled changes are one of the main causes of pharmaceutical quality incidents and recalls. For example, an apparently minor change to a process parameter may alter the impurity profile of a medicine; changing a packaging material supplier may affect its sealing properties and stability. In the view of the regulatory authority, the absence of an effective change control system means your entire quality system is fragile and unpredictable, an unacceptable risk.

Q379 · 卫生署视察员反复强调“数据完整性”（Data Integrity），这具体指的是什么？独立链接

Data integrity has been a major focus of pharmaceutical regulators worldwide in recent years. It refers to the “ALCOA+” principles, which require data throughout its lifecycle to be: attributable (who did it), legible, contemporaneous (recorded at the time the activity occurred), original and accurate. The “+” stands for complete, consistent, enduring and available. Put simply, data integrity requires all your records, whether on paper or electronic, to be genuine, reliable and untampered with. For example, an analyst must not record experimental data on scrap paper and then transcribe it into the official logbook after obtaining a “good” result; an electronic system must not allow ordinary users to amend or delete data at will without any audit trail.

📘 Regulatory basis

Major regulatory bodies such as PIC/S, WHO and FDA have all issued specific data integrity guidance. Although the Department of Health in Hong Kong has no separate guideline, its GMP/GDP inspections fully adopt the internationally recognised ALCOA+ principles as assessment criteria.

📗 Drew Tang's recommendations

We recommend that clients conduct a comprehensive data integrity risk assessment covering the entire process from data generation and processing through to reporting and archiving. For paper records, standardise record-keeping practices, prohibit pencils and correction fluid, and ensure signatures and dates are recorded correctly. For electronic systems, ensure compliance with FDA 21 CFR Part 11, with features such as audit trails, access controls and electronic signatures. Training staff in a culture of data integrity is more important than any technical measure.

📕 Risk notice

Data integrity issues, particularly the falsification or alteration of data, are the one type of non-compliance to which regulators apply “zero tolerance”. If conclusive evidence is found—for example, hidden or altered data discovered by checking waste paper, the computer recycle bin or the system audit trail—the Department of Health will almost certainly take the most severe measures, including licence revocation and criminal prosecution. This is an industry “cardinal sin”.

Q380 · 在我们的组织架构中，质量部门（QA/QC）应该扮演什么样的角色？独立链接

In organisations operating in accordance with GDP/GMP, the Quality Unit has an independent and critical role. It consists of Quality Assurance (QA) and Quality Control (QC). QC primarily assesses whether the quality of raw materials, intermediates and finished products meets established standards through sampling and testing. QA has a broader role: it establishes, implements and maintains the company's overall Quality Management System (QMS), ensuring that all activities affecting product quality are controlled. The Quality Unit must be independent of the production or sales departments and have sufficient authority and resources to fulfil its responsibilities. Its core duties include approving or rejecting all quality-related materials and products, approving all SOPs and master documents, managing quality system processes such as deviations, changes and complaints, organising self-inspections, and making the final decision on whether each batch may be released for sale.

📘 Regulatory basis

Chapter 2 of the PIC/S GMP Guide expressly provides that the heads of quality assurance, pharmaceutical production and quality control should be independent of one another. The quality department must participate in all quality-related decisions.

📗 Drew Tang's recommendations

We recommend that the company’s senior management fully empower the head of the quality department and support them in making independent quality decisions, even when those decisions may conflict with short-term commercial interests (such as meeting delivery deadlines). The quality department should not be regarded as the “police” or an “obstacle”, but as a partner helping business teams achieve their objectives within the compliance framework. Holding regular management review meetings with senior management participation is an effective way to ensure that the quality system receives sufficient attention and resources.

📕 Risk notice

If the quality department does not have an independent status and its head has to report to the production or sales manager, it will be difficult for its quality decisions to be objective and impartial. In the regulator’s view, this is a fundamental organisational defect that indicates an ineffective quality assurance system. During an inspection, inspectors will assess the independence and effectiveness of the quality department through interviews and document reviews. Any evidence of interference with quality decisions may have serious consequences.

Q381 · 我们的药房（获授权毒药销售商）在储存和陈列不同类别的“毒药”时，有什么具体规定？独立链接

As a pharmacy, you must comply with strict legal requirements for the storage and display of different categories of poisons, in order to protect public safety and prevent misuse or abuse. Part I poisons (prescription medicines) must never be accessible to the public and must be stored in a “non-public area”, such as a dispensing room or locked cabinet. Part II poisons (medicines sold by medicine shops) may be displayed in public areas, but must be kept separate from other non-medicinal goods, such as food and cosmetics. Certain Part I poisons listed in Schedule 1 are subject to stricter requirements: they must be kept in a locked container, with the key held by a registered pharmacist. All poison storage areas should also be kept clean and dry and protected from direct sunlight to maintain medicine quality.

📘 Regulatory basis

Sections 10 and 11 of the Pharmacy and Poisons Regulations (Cap. 138A) clearly prescribe the storage and custody requirements for Part I and Part II poisons, with the aim of physically segregating medicines with different levels of risk.

📗 Drew Tang's recommendations

We recommend that pharmacies take these requirements fully into account when designing their shop layout. Use clear labels and shelving partitions to distinguish clearly between different categories of products. Train all staff to ensure they know which medicines may be displayed openly and which must be kept under strict control. RGYS may assist with document preparation and project coordination within the written scope of services; personnel qualifications, statutory roles and professional judgements are to be verified and assumed by the respective responsible parties, while approval is determined independently by the competent authority. This can also demonstrate your professionalism to customers.

📕 Risk notice

Leaving prescription medicines where customers can easily reach them is an extremely serious breach. If discovered during a Department of Health inspection or if it leads to an incident, the pharmacy may face disciplinary action, including a fine or even revocation of its licence. The pharmacist in charge may also face allegations of professional misconduct.

Q382 · 作为批发商，我们是否可以将大包装的药品拆分后，以小包装单位出售给下游客户？独立链接

As a general rule, a licensed wholesaler should not split or repackage medicines without authorisation, as this constitutes a manufacturing activity and requires a Manufacturer of Pharmaceutical Products licence. You should distribute medicines in the smallest sales unit approved at the time of product registration. Any change to medicine packaging, including opening a bulk pack and repacking it into smaller bottles or boxes, may introduce risks such as cross-contamination, labelling errors and loss of batch number and expiry-date information, thereby compromising the integrity and traceability of the medicines. If you have a genuine business need to carry out such activities, you must apply for a Manufacturer of Pharmaceutical Products licence (secondary packaging) and comply strictly with GMP requirements, carrying out the work in a controlled clean environment and maintaining complete batch packaging records.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance (Cap. 138) defines “packaging for sale” as part of “manufacture”. Repackaging medicines without a manufacturer’s licence may therefore constitute unlawful manufacturing.

📗 Drew Tang's recommendations

If your downstream customers (such as clinics and pharmacies) genuinely require smaller pack sizes, we recommend purchasing the required pack size directly from a manufacturer or supplier holding a Manufacturer Licence. This is far safer and more compliant than taking the risk of repackaging products yourself. If you decide to apply for a secondary packaging licence, Rengangyongsheng (Hong Kong) Limited can provide a full suite of services covering GMP facility design, quality system establishment and licence applications.

📕 Risk notice

Unauthorised splitting and repackaging of medicines will be regarded as illegal manufacturing if discovered by the Department of Health. This is a very serious allegation and may result in criminal prosecution and revocation of the existing Wholesale Dealer Licence. In addition, if improper repackaging causes quality problems or harm to patients, you will bear full legal and compensation liability.

Q383 · 对于我们药房保存的旧处方，其中包含病人个人信息，应如何妥善处置？独立链接

A prescription is not only the legal basis for dispensing; it also contains sensitive personal information protected under the Personal Data (Privacy) Ordinance (Cap. 486). It must therefore be handled with great care. First, under the regulations, prescriptions must be kept for at least two years from the date of dispensing. During this period, they must be stored securely to prevent unauthorised access. Once the retention period has expired, they must never be discarded directly as ordinary waste paper. You must destroy them securely to ensure that patient information cannot be recovered. The most common methods are shredding them or engaging a professional confidential document destruction company, and obtaining a certificate of destruction.

📘 Regulatory basis

The Pharmacy and Poisons Regulations (Cap. 138A) require prescriptions to be retained for two years. Data Protection Principle 4 under the Personal Data (Privacy) Ordinance provides that data users must take all practicable steps to ensure that personal data is protected against unauthorised or accidental access, processing or use.

📗 Drew Tang's recommendations

We recommend that pharmacies establish a clear document retention and destruction policy. Prescriptions that have passed their retention period can be destroyed in batches quarterly or annually. Using a high-security cross-cut shredder is a cost-effective in-house method. If prescription volumes are large, outsourcing to a professional destruction company is more efficient and can provide independent evidence of compliance.

📕 Risk notice

Improper disposal of prescriptions containing patient information, if it results in a data breach, will breach both medicines legislation and privacy legislation. The Office of the Privacy Commissioner for Personal Data has the power to investigate and impose penalties. More seriously, this will severely damage your professional reputation and customer trust, causing irreparable harm to the pharmacy’s reputation.

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.

📘 Regulatory basis

The Code of Practice for Licensed Wholesale Dealers requires storage conditions to be monitored continuously, with any deviations investigated and recorded. This is a core requirement of the quality management system.

📗 Drew Tang's recommendations

Prevention is better than cure. We strongly recommend that clients install backup air-conditioning systems and generators in critical temperature-controlled warehouses. A reliable 24-hour temperature alarm system with remote notifications is an essential investment. Establish communication channels with medicine manufacturers in advance so that technical support can be obtained quickly if such an incident occurs. Prepare a detailed emergency SOP and conduct drills with staff to ensure they know what to do in a real emergency.

📕 Risk notice

Mishandling a temperature excursion or attempting to conceal it is extremely dangerous. Supplying medicines that may have deteriorated to customers directly endangers patient safety. If a Department of Health inspection finds that you have temperature excursion records but did not investigate or deal with them appropriately, this will be considered a critical deficiency, demonstrating a complete failure of your quality system and potentially justifying suspension or revocation of your licence.

Q385 · 什么是“质量风险管理”（QRM）？它在我们的日常运营中如何应用？独立链接

Quality Risk Management (QRM) is a systematic process for assessing, controlling, communicating and reviewing quality risks that may arise throughout a medicine’s lifecycle. It goes beyond simply “following rules”: it proactively and prospectively identifies where things could go wrong and how serious the consequences could be, and allocates resources accordingly, giving priority to high-risk areas. In day-to-day operations, QRM can be applied when conducting risk assessments of different suppliers; assessing risks that may arise from a change during change control; using risk tools to analyse root causes when investigating deviations; and determining the frequency and depth of self-inspections or supplier audits on a risk basis. The key is to make your quality management activities more targeted and direct limited resources where they are most needed.

📘 Regulatory basis

The International Council for Harmonisation (ICH) Q9 guideline, Quality Risk Management, is a globally recognised industry standard. The principles of QRM have been fully incorporated into PIC/S GMP and GDP guidelines, requiring licence holders to establish and operate their quality systems on a risk-based basis.

📗 Drew Tang's recommendations

We recommend that clients start with simple risk management tools, such as FMEA (Failure Mode and Effects Analysis). For example, you could organise a cross-functional team to conduct an FMEA of your goods receipt process, identify all possible “failure modes” (such as receiving the wrong goods or a faulty thermometer), assess their likelihood, severity and detectability, and then develop improvements for high-risk points. Incorporating QRM thinking into day-to-day decisions can make your quality system “smarter” and more efficient.

📕 Risk notice

In the modern pharmaceutical regulatory environment, a Quality Management System (QMS) without risk management is considered outdated and ineffective. If you cannot explain to inspectors why you classify a particular area or process as high risk and have introduced additional controls, or why you consider a deviation low risk and have dealt with it in a simplified way, this may indicate that your decisions are arbitrary and lack a scientific basis. This will reduce the regulatory authorities’ confidence in your overall quality system.

Q386 · 我们应该如何管理和控制我们公司的“标准操作程序”（SOP）文件？独立链接

Standard Operating Procedures (SOPs) are the foundation of a Quality Management System, ensuring operational consistency and compliance. SOP management must be strict and systematic. This includes: 1. Drafting and review: SOPs should be drafted by personnel familiar with the operation, reviewed by the relevant departments (such as the user department and quality department), and ultimately approved by the head of the quality department. 2. Version control: Every SOP must have a unique number, version number and effective date. Any amendment must follow the change control procedure and result in a new version number. Superseded SOPs must be withdrawn immediately from all points of use to prevent misuse. 3. Distribution and training: Controlled copies of SOPs should be distributed to all roles that need to carry out the relevant operations. Relevant employees must be trained before an SOP takes effect, and the training must be documented. 4. Periodic review: All SOPs should be reviewed periodically (for example, every two years) to ensure that their content remains accurate and applicable. If regulations or processes change, they should be revised immediately. 5. Archiving: The master copy of every SOP and all historical versions should be properly archived.

📘 Regulatory basis

Both GMP and GDP guidelines require written procedures to cover all key operations that affect medicine quality, and require these procedures to be properly controlled and managed.

📗 Drew Tang's recommendations

We recommend using an electronic document management system (EDMS) to manage SOPs. This can greatly simplify version control, distribution, retrieval and training record management, while ensuring that employees can always access the latest, sole correct version. SOPs should use clear, concise and unambiguous language, with flowcharts and diagrams used extensively to make them easy to understand and follow.

📕 Risk notice

Poor SOP management is a common inspection deficiency. If staff are found using an obsolete SOP at the workplace, or if actual operations do not match the SOP, this will be regarded as a major deficiency. It indicates that your written procedures are disconnected from actual operations and that your quality system is ineffective. If a quality incident results from following an incorrect SOP, the company will be held responsible.

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.

📘 Regulatory basis

The Code of Practice for Licensed Wholesale Dealers has dedicated chapters on handling returned goods and recalls, requiring written procedures and complete records to be maintained.

📗 Drew Tang's recommendations

We recommend that clients design dedicated record forms for these “problem medicines” to ensure that all required information is captured. Provide dedicated training to warehouse staff responsible for handling returns so that they understand the importance of segregation and record-keeping. Conduct regular stocktakes in the quarantine area to ensure that physical stock matches the records. Take particular care when deciding whether high-value returned goods can be returned to stock; if in any doubt, destroy them.

📕 Risk notice

Failure to effectively segregate and control non-conforming goods is a “critical deficiency” in a GDP inspection. If inspectors find recalled goods that should have been segregated stored together with released goods, or you cannot provide the final disposition record for a batch of returned goods, this indicates a serious risk that unsafe medicines could re-enter the market and may lead to immediate regulatory action.

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.

📘 Regulatory basis

Both GMP and GDP guidelines expressly require key equipment used for measurement, weighing, recording and control to be calibrated and checked regularly, with relevant records retained.

📗 Drew Tang's recommendations

We recommend that clients centrally manage calibration plans and records for all critical equipment, using a simple spreadsheet or specialist equipment management software to track due dates and prevent anything being overlooked. If calibration shows that equipment is outside tolerance, a deviation investigation must be initiated to assess the validity of all measurement data affected by the equipment since its last satisfactory calibration, and determine whether product quality was affected.

📕 Risk notice

Data generated using equipment that has not been calibrated or is overdue for calibration is invalid. For example, if the temperature records in your warehouse were generated by a probe that reads 2°C below the true temperature, all your “compliant” temperature records are false, and the medicines may already have been exposed to temperatures outside the permitted range. During an inspection, checking the calibration labels and certificates of critical equipment is a standard requirement; any omission will be recorded as a deficiency.

Q389 · 如果执法机构（如香港海关或警方）要求查阅我们的药品分销记录，我们应该如何应对？独立链接

You must cooperate with lawful requests from law enforcement agencies, while also following procedures to protect the legitimate interests of the company and its customers. The appropriate steps are: 1. Verify identity and authority: Politely ask the officers to show their identification and search warrant or other relevant legal authorisation. You are entitled to verify that they have lawful authority. 2. Contact management and legal counsel: Immediately notify senior management and/or legal counsel so they are aware of the situation and can provide guidance. 3. Clarify the scope and accompany the officers: Establish clearly which records they wish to inspect (for example, for a specific medicine, period or customer). Assign a senior employee to accompany them throughout the inspection, without obstructing their work. 4. Provide copies, not originals: Where possible, provide copies rather than originals. If the officers insist on taking originals, require a detailed receipt listing all documents taken. 5. Record the process: Keep a detailed record of the incident, including the officers’ names and departments, their arrival and departure times, and a list of all documents inspected or taken.

📘 Regulatory basis

Although medicines legislation requires you to keep records, other laws, such as the Criminal Procedure Ordinance, empower law enforcement agencies to inspect and seize evidence in certain circumstances. At the same time, you are responsible for protecting customer information under the Personal Data (Privacy) Ordinance, unless disclosure is required by law.

📗 Drew Tang's recommendations

We recommend that the company prepare an SOP in advance for responding to enforcement inspections and train key staff. Keeping all distribution records complete, accurate and readily retrievable will enable the required information to be provided quickly and accurately in such circumstances, avoiding unnecessary suspicion caused by disorganisation. If you are unsure how to proceed, it is prudent to delay and seek advice from legal counsel.

📕 Risk notice

Obstructing enforcement officers in the execution of their duties is a criminal offence. However, handing over large volumes of records containing commercially sensitive information and customer privacy data to others without verifying their authority is also irresponsible. It is essential to strike a balance between cooperation and caution. An inappropriate response may expose the company to legal risks or reputational damage.

Q390 · 什么是“合格人士”（QP）与“负责人”（RP）？他们在药品监管中的角色有何不同？独立链接

A “Qualified Person” (QP) and a “Responsible Person” (RP) are two distinct but equally important roles in the regulatory framework for medicines. QP is a legal concept under the EU and PIC/S GMP systems and is primarily found in pharmaceutical manufacturing. The QP’s core responsibility is to personally review batch records and issue a declaration before each batch of medicine is placed on the market, confirming that the manufacturing and testing of the batch fully comply with GMP requirements and the marketing authorisation. The QP bears personal legal responsibility for product quality. By contrast, the RP is a GDP concept found primarily in pharmaceutical wholesale and distribution. The RP is responsible for ensuring that the wholesaler’s Quality Management System is effectively implemented and maintained, and that medicines retain their quality and integrity during storage and distribution. The RP is responsible for compliance in wholesale activities. In short, the QP is responsible for “release from manufacture” and ensuring manufacturing quality; the RP is responsible for “distribution compliance” and ensuring supply chain quality.

📘 Regulatory basis

Chapter 2 of the PIC/S GMP Guide defines the responsibilities and qualification requirements of a QP in detail. Hong Kong's Drug Wholesalers Code of Practice sets out the appointment and responsibilities of an RP.

📗 Drew Tang's recommendations

Companies holding both a Manufacturer of Pharmaceutical Products licence and a wholesale licence must clearly distinguish the responsibilities of the two roles and define them in their quality system documentation. Although the same person may hold both roles in a small company, they must have all the knowledge and experience required for each role and be able to “switch hats” clearly when performing different duties. The QP’s decisions should focus on the batch itself, while the RP’s decisions should cover the entire distribution chain.

📕 Risk notice

Confusion over the responsibilities of the QP and RP may create regulatory gaps. For example, a QP focused only on production may overlook risks in distribution, while an RP familiar only with storage may be unable to make an informed quality assessment of production deviations. The performance of these two key roles is assessed in depth during Department of Health inspections; unclear responsibilities or insufficient capability will be treated as a major systemic deficiency.

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