2013/C 343/01 欧盟GDP （中英文1/2）

一沙一叶

Guidelines of

5 November 2013

on Good Distribution Practice of medicinal products for human use

人用药品GDP指南

(Text with EEA relevance)

(2013/C 343/01)

INTRODUCTION 前言

These Guidelines are based on Article 84 and Article 85b(3) of Directive 2001/83/EC ( [1] ).

本指南是依据指令2001/83/EC第84条和第85b(3)条制订的。

The Commission has published EU Guidelines on Good Distribution Practice (GDP) in 1994 ([2]). Revised guidelines were published in March 2013 ([3]) in order to take into account recent advances in practices for appropriate storage and distribution of medicinal products in the European Union, as well as new requirements introduced by Directive 2011/62/EU ([4]).

欧盟委员会在1994年公布了欧盟GDP指南，修订版本于2013年3月公布。修订版本中考虑了欧盟内药品存贮和分销操作的最新进展，以及由指令2011/62/EU引入的新要求。

This version corrects factual mistakes identified in subchapters 5.5 and 6.3 of the revised guidelines. It also gives more explanations on the rationale for the revision as well as a date of coming into operation.

本版本纠正了修订指南在章节5.5和6.3中的实际错误。它还对修订原因给出了更多解释，并给出了实施日期。

It replaces the guidelines on GDP published in March 2013.

本指南取代2013年3月出版的GDP指南。

The wholesale distribution of medicinal products is an important activity in integrated supply chain management. Today’s distribution network for medicinal products is increasingly complex and involves many players. These Guidelines lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain. Compliance with these Guidelines will ensure control of the distribution chain and consequently maintain the quality and the integrity of medicinal products.

药品批发分销是整个供应链管理中的一个重要环节。目前的药品分销网络更加复杂，涉及更多参与方。本指南提供了适当的工具，协助批发分销商实施其活动，防止假药进入合法的供应链。符合这些指南能保证对分销链的控制，从而维护药品的质量和完整性。

According to Article 1(17) of Directive 2001/83/EC, wholesale distribution of medicinal products is ‘all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned’.

根据指令2001/83/EC第1（17）条，药品批发分销商是“包括采购、存贮、供应或出口药品的所有活动，只是不向公众销售药品。这些活动与生产商或其保管商、出口商、其它批发分销商或药师和授权人或在相关成员国内被授权可以向公众提供药品的各方一起运作的”。

Any person acting as a wholesale distributor has to hold a wholesale distribution authorisation. Article 80(g) of Directive 2001/83/EC provides that distributors must comply with the principles of and guidelines for GDP.

所有进行批发的分销商必须持有批发分销许可证。指令2001/83/EC第80(g)条指出分销商必须遵守的原则，也是GDP指南的依据。

Possession of a manufacturing authorisation includes authorisation to distribute the medicinal products covered by the authorisation. Manufacturers performing any distribution activities with their own products must therefore comply with GDP.

持有生产许可包括被允许销售许可所覆盖的药品。生产商在销售其自己生产药品时，必须符合GDP要求。

The definition of wholesale distribution does not depend on whether that distributor is established or operating in specific customs areas, such as in free zones or in free warehouses. All obligations related to wholesale distribution activities (such as exporting, holding or supplying) also apply to these distributors. Relevant sections of these Guidelines should also be adhered to by other actors involved in the distribution of medicinal products.

对批发分销商的定义并不取决于该分销商是否在特定的海关区内建立或运作，例如在自由贸易区或在自由仓储区。所有与批发分销活动相关的义务（例如出口、存贮或供应）也适用于这些分销商。牵涉到药品分销过程的其它行为人也应遵守本指南的相关部分。

Other actors such as brokers may also play a role in the distribution channel for medicinal products. According to Article 85b of Directive 2001/83/EC, persons brokering medicinal products must be subject to certain provisions applicable to wholesale distributors, as well as specific provisions on brokering.

其它行为人，如中间商也会在药品销售通道中起到一定作用。根据指令2001/83/EC第85b条，销售药品的中间商必须遵守适用于批发分销商和中间商的特定条款。

CHAPTER 1 — QUALITY MANAGEMENT

第一章—质量管理

1.1. Principle 总则

Wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management principles in relation to their activities ([5]). All distribution activities should be clearly defined and systematically reviewed. All critical steps of distribution processes and significant changes should be justified and where relevant validated. The quality system is the responsibility of the organisation’s management and requires their leadership and active participation and should be supported by staff commitment.

批发分销商必须保持其质量体系，根据其活动设定人员职责、工作流程和风险管理原则。所有分销活动应进行清楚界定，和系统性地审核。所有分销流程中的关键步骤和重大变更均应进行论证，适当时应进行验证。组织结构中的管理层对质量体系负有责任。质量体系应由管理层领导、主动参与，并由员工承诺加以支持。

1.2. Quality system 质量体系

The system for managing quality should encompass the organisational structure, procedures, processes and resources, as well as activities necessary to ensure confidence that the product delivered maintains its quality and integrity and remains within the legal supply chain during storage and/or transportation.

质量管理体系应指导组织结构、程序、流程建立和资源配置，以及所有必须的活动，以保证发运的产品能维持其质量和完整性，在整个存贮和/或运输阶段均保证在合法的供应链以内受控。

The quality system should be fully documented and its effectiveness monitored. All quality-system-related activities should be defined and documented. A quality manual or equivalent documentation approach should be established.

质量体系应被完整记录并受到有效监督。所有质量体系相关的活动均应进行界定并记录。要建立一份质量手册或类似的文件。

A responsible person should be appointed by the management, who should have clearly specified authority and responsibility for ensuring that a quality system is implemented and maintained.

管理层应任命一名负责人，赋予其明确的职权，以保证实施和维护质量体系。

The management of the distributor should ensure that all parts of the quality system are adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities.

分销商的管理层应保证所有的质量体系部分均能获得充足的有资质人力资源、适当和充分的设施、设备和公用系统支持。

The size, structure and complexity of distributor’s activities should be taken into consideration when developing or modifying the quality system.

在建立和改组质量体系时，应考虑销售活动的规模、组织结构和复杂性。

A change control system should be in place. This system should incorporate quality risk management principles, and be proportionate and effective.

应有变更控制系统。该系统应结合质量风险管理原则，应适当并有效。

The quality system should ensure that:

i.         medicinal products are procured, held, supplied or exported in a way that is compliant with the requirements of GDP;

ii.       management responsibilities are clearly specified;

iii.      products are delivered to the right recipients within a satisfactory time period;

iv.     records are made contemporaneously;

v.       deviations from established procedures are documented and investigated;

vi.     appropriate corrective and preventive actions (commonly known as ‘CAPA’) are taken to correct deviations and prevent them in line with the principles of quality risk management.

质量体系应保证：

i.         药品的采购、保管、销售和出口符合GDP规定

ii.       明确界定管理责任

iii.      产品在令人满意的时间段时发送给正确的接收人

iv.     同步记录

v.       记录和调查偏离既定程序的事件

vi.     根据质量风险管理的原则采取纠正和预防措施（一般称为CAPA）以纠正偏差并防止其再次发生

1.3. Management of outsourced activities  外包活动的管理

The quality system should extend to the control and review of any outsourced activities related to the procurement, holding, supply or export of medicinal products. These processes should incorporate quality risk management and include:

(i) assessing the suitability and competence of the contract acceptor to carry out the activity and checking authorisation status, if required;

(ii) defining the responsibilities and communication processes for the quality-related activities of the parties involved;

(iii) monitoring and review of the performance of the contract acceptor, and the identification and implementation of any required improvements on a regular basis.

质量体系应延伸到对于与药品采购、保管、销售或出口有关的外包活动的控制和审核。这些流程应与质量风险管理相结合，包括以下内容：

i.         评估承包商对所需实施活动是否适合，评估其能力，必要时检查其合法状态

ii.       界定相关方与质量有关的活动的责任分工及沟通流程

iii.      监督并审核承包商的表现，提出并实施在法规方面所需的改进

1.4. Management review and monitoring 管理评审和监督

The management should have a formal process for reviewing the quality system on a periodic basis. The review should include:

(i) measurement of the achievement of quality system objectives;

(ii) assessment of performance indicators that can be used to monitor the effectiveness of processes within the quality system, such as complaints, deviations, CAPA, changes to processes; feedback on outsourced activities; self-assessment processes including risk assessments and audits; and external assessments such as inspections, findings and customer audits;

(iii) emerging regulations, guidance and quality issues that can impact the quality management system;

(iv) innovations that might enhance the quality system;

(v) changes in business environment and objectives.

管理层应制订正式的流程，对质量体系定期进行审核。审核内容应包括：

i.         对质量体系目标达成情况进行测算

ii.       评估用以监督质量体系内流程有效性的绩效指标，例如客诉、偏差、CAPA、流程变更、外包活动的反馈情况；自评流程包括风险评估和审计，外评如官方检查、缺陷和客户审计

iii.      可能对质量管理体系形成影响的新的法规、指南和质量问题

iv.     可能加强质量体系的创新

v.       业务环境和目标变化

The outcome of each management review of the quality system should be documented in a timely manner and effectively communicated internally.

每次质量体系评审结果均应及时记录，并在内部进行有效沟通。

1.5. Quality risk management 质量风险管理

Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of medicinal products. It can be applied both proactively and retrospectively.

质量风险管理是对药品质量风险进行评估、控制、沟通和回顾的一个系统性过程。它可以提前进行，也可以回顾性地进行。

Quality risk management should ensure that the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient. The level of effort, formality and documentation of the process should be commensurate with the level of risk. Examples of the processes and applications of quality risk management can be found in guideline Q9 of the International Conference on Harmonisation (‘ICH’).

质量风险管理应保证对质量风险的评估是基于科学知识、对工艺的了解，并与对患者的保护最终相关。管理过程的努力程度、正式水平和记录深度应与风险水平相当。ICH指南 Q9中给出了质量风险管理流程及应用实例。

CHAPTER 2 — PERSONNEL

第二章---人员

2.1. Principle 通则

The correct distribution of medicinal products relies upon people. For this reason, there must be sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible. Individual responsibilities should be clearly understood by the staff and be recorded.

正确实施药品分销主要依赖于人员。因此，必须要有足够的具有资质的人员来执行批发分销商所负责的所有工作。每个人应清楚其所承担的责任，并有书面记录。

2.2. Responsible person 人员职责

The wholesale distributor must designate a person as responsible person. The responsible person should meet the qualifications and all conditions provided for by the legislation of the Member State concerned ([6]). A degree in pharmacy is desirable. The responsible person should have appropriate competence and experience as well as knowledge of and training in GDP.

批发分销商必须任命一名负责人，负责人必须具备一定资质，满足成员国相关法律要求的条件。药学学位者最为理想。负责人应具备适当的能力和经验，并具备GDP知识，接受过GDP培训。

The responsible person should fulfil their responsibilities personally and should be continuously contactable. The responsible person may delegate duties but not responsibilities.

负责人应履行其个人职责，应保持可以联络。负责人可以授权他人行使权利，但不能转让其责任。

The written job description of the responsible person should define their authority to take decisions with regard to their responsibilities. The wholesale distributor should give the responsible person the defined authority, resources and responsibility needed to fulfil their duties.

负责人的书面职责说明书应界定其在履行其职责时做出决定的权力。批发分销商应赋予负责人相应的权利、资源和职责，以满足其承担义务的需要。

The responsible person should carry out their duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met.

负责人应承担其职责，保证批发分销商可以符合GDP要求，履行对公众服务的义务。

The responsibilities of the responsible person include:

(i) ensuring that a quality management system is implemented and maintained;

(ii) focusing on the management of authorised activities and the accuracy and quality of records;

(iii) ensuring that initial and continuous training programmes are implemented and maintained;

(iv) coordinating and promptly performing any recall operations for medicinal products;

(v) ensuring that relevant customer complaints are dealt with effectively;

(vi) ensuring that suppliers and customers are approved;

(vii) approving any subcontracted activities which may impact on GDP;

(viii) ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;

(ix) keeping appropriate records of any delegated duties;

(x) deciding on the final disposition of returned, rejected, recalled or falsified products;

(xi) approving any returns to saleable stock;

(xii) ensuring that any additional requirements imposed on certain products by national law are adhered to ([7]).

负责人的职责包括

i.         保证实施和维护一个质量管理体系

ii.       关注被授权活动的管理，以及记录的准确和质量

iii.      保证实施和维护入职培训和在职持续培训程序

iv.     协调并及时进行药品召回操作

v.       保证相关客户投诉被高效处理

vi.     保证供应商和客户经过批准

vii.    批准所有可能对GDP有影响的分包活动

viii.  保证根据预订的计划定期实施自检，以及制订必要的纠正措施

ix.     保持所有法定义务下适当的记录

x.       决定对退回、拒收、召回或假药的最终处理

xi.     批准退货进入可销售库存

xii.    保证满足所有根据国家法律制订的对特定药品的额外要求

2.3. Other personnel 其它人员

There should be an adequate number of competent personnel involved in all stages of the wholesale distribution activities of medicinal products. The number of personnel required will depend on the volume and scope of activities.

药品批发分销整个过程的所有阶段均应有足够数量，具有相应能力的人员来操作。所需的人员数量取决于活动的数量和范围。

The organisational structure of the wholesale distributor should be set out in an organisation chart. The role, responsibilities, and interrelationships of all personnel should be clearly indicated.

批发分销商的组织机构应在组织机构图中设定，要清楚指出所有人员的作用、职责和相互关系 。

The role and responsibilities of employees working in key positions should be set out in written job descriptions, along with any arrangements for deputising.

在关键职位工作的人员的作用和职责应在书面的工作说明中列出，同时写明（缺席时的）委托安排。

2.4. Training 培训

All personnel involved in wholesale distribution activities should be trained on the requirements of GDP. They should have the appropriate competence and experience prior to commencing their tasks.

所有与批发销售活动相关的人员均应培训使了解GDP的要求。他们在承担其任务前应具备适当的资质和经验。

Personnel should receive initial and continuing training relevant to their role, based on written procedures and in accordance with a written training programme. The responsible person should also maintain their competence in GDP through regular training.

人员应接受与其职责相关的入职培训和在职持续培训，培训内容应基于书面程序，培训流程应根据书面的培训程序。负责人还应通过定期参加维持其GDP资质。

In addition, training should include aspects of product identification and avoidance of falsified medicines entering the supply chain.

另外，培训应包括对产品的鉴别方面的知识，以避免假药进入供应链。

Personnel dealing with any products which require more stringent handling conditions should receive specific training. Examples of such products include hazardous products, radioactive materials, products presenting special risks of abuse (including narcotic and psychotropic substances), and temperature-sensitive products.

如果所操作的产品需要更为严格的处置条件，则该人员应接受特殊的培训。这类产品的例子包括危险产品、辐射物质、可能会被滥用的药品（包括麻醉类和精神类药物）和对温度敏感的药品。

A record of all training should be kept, and the effectiveness of training should be periodically assessed and documented.

所有培训的记录均应保存，培训有效性应定期进行评估并记录。

2.5. Hygiene 卫生

Appropriate procedures relating to personnel hygiene, relevant to the activities being carried out, should be established and observed. Such procedures should cover health, hygiene and clothing.

要建立适当程序管理人员卫生，与其要进行的操作相适当，并进行监管。这些程序应包括健康、卫生和更衣流程。

CHAPTER 3 — PREMISES AND EQUIPMENT

第三章—设施与刘备

3.1. Principle 通则

Wholesale distributors must have suitable and adequate premises, installations and equipment ([8]), so as to ensure proper storage and distribution of medicinal products. In particular, the premises should be clean, dry and maintained within acceptable temperature limits.

批发销售商必须具备适当的充足的设施和设备并适当安装，以保证为药品提供适当的存贮和销售条件。特别要注意的是，设施必须清洁、干燥并维持在可接受的温度限度内。

3.2. Premises 设施

The premises should be designed or adapted to ensure that the required storage conditions are maintained. They should be suitably secure, structurally sound and of sufficient capacity to allow safe storage and handling of the medicinal products. Storage areas should be provided with adequate lighting to enable all operations to be carried out accurately and safely.

设施的设计或改造应保证其能维护所需的存贮条件。设施应有适当的安保，结构合理，具有充足的能力保障对药品进行安全的存贮和处置。存贮区域应提供足够的照明，以使所有操作能准确安全地进行。

Where premises are not directly operated by the wholesale distributor, a contract should be in place. The contracted premises should be covered by a separate wholesale distribution authorisation.

如果设施并不由批发分销商直接运作，则需要订有合同。合同外包设施应由一个独立有授权的批发分销商承担。

Medicinal products should be stored in segregated areas which are clearly marked and have access restricted to authorised personnel. Any system replacing physical segregation, such as electronic segregation based on a computerised system, should provide equivalent security and should be validated.

药品应存贮在被隔离的区域内，区域应有清楚标识，只有经授权的人员方可进入。所有替代物理隔离的系统，例如采用计算机化系统的电子隔离系统，均应具备相当的安保功能，并经过验证。

Products pending a decision as to their disposition or products that have been removed from saleable stock should be segregated either physically or through an equivalent electronic system. This includes, for example, any product suspected of falsification and returned products. Medicinal products received from a third country but not intended for the Union market should also be physically segregated. Any falsified medicinal products, expired products, recalled products and rejected products found in the supply chain should be immediately physically segregated and stored in a dedicated area away from all other medicinal products. The appropriate degree of security should be applied in these areas to ensure that such items remain separate from saleable stock. These areas should be clearly identified.

待处理的药品和已从可销售库存中移出的产品应采用物理或相当的电子系统进行隔离。这类药品包括，例如，有假药嫌疑的药品和收到的退货。从第三国收到，但不准备在欧盟市场上销售的药品也应进行物理隔离。所有在供应链中发现的假药、失效药品、召回产品和拒收产品，均应立即进行物理隔离，存贮在远离其它药品的专用区域。该专用区域应有适当程度的安保，以保证这些物品与可销售库存保持区分。这些区域要进行明确标识。

Special attention should be paid to the storage of products with specific handling instructions as specified in national law. Special storage conditions (and special authorisations) may be required for such products (e.g. narcotics and psychotropic substances).

应特别注意根据国家法律有特殊操作指示的药品的存贮。这些药品（例如麻醉品和精神类药品）可能需要有特殊存贮条件（和特殊授权）。

Radioactive materials and other hazardous products, as well as products presenting special safety risks of fire or explosion (e.g. medicinal gases, combustibles, flammable liquids and solids), should be stored in one or more dedicated areas subject to local legislation and appropriate safety and security measures.

辐射物料和其它有毒产品，以及有特殊防火或防爆要求的产品（例如药用气体、可燃物、易燃液体和固体），应存贮在一个或多个符合当地法规要求的专用区域，采取适当的安全和防护措施。

Receiving and dispatch bays should protect products from prevailing weather conditions. There should be adequate separation between the receipt and dispatch and storage areas. Procedures should be in place to maintain control of inbound/ outbound goods. Reception areas where deliveries are examined following receipt should be designated and suitably equipped.

接收和发运区应能防止产品受到天气条件的侵害。在接收发运区和存贮区域之间，应有充分的隔离。应制订程序维护对界内和界外货品的控制。接收后的货物应在指定的接收区进行检查，该区应配备适当的设施。

Unauthorised access to all areas of the authorised premises should be prevented. Prevention measures would usually include a monitored intruder alarm system and appropriate access control. Visitors should be accompanied.

应防止非法进入受控设施内的任何区域。预防措施一般包括受监控的非法闯入警报系统和适当的入口权限控制。参观者应有人陪同。

Premises and storage facilities should be clean and free from litter and dust. Cleaning programmes, instructions and records should be in place. Appropriate cleaning equipment and cleaning agents should be chosen and used so as not to present a source of contamination.

设施和存贮场所应清洁，没有垃圾和污物。应有清洁程序、指令和记录。应选择使用适当的清洁设备和清洁剂，保证不使其成为污染源。

Premises should be designed and equipped so as to afford protection against the entry of insects, rodents or other animals. A preventive pest control programme should be in place.

设施的设计和装备应使其能防止昆虫、啮齿动物或其它动物进入。应建立预防性的害虫控制程序。

Rest, wash and refreshment rooms for employees should be adequately separated from the storage areas. The presence of food, drink, smoking material or medicinal products for personal use should be prohibited in the storage areas.

员工休息、盥洗和休息间应与存贮区域分开。在存贮区内不得出现食品、饮料、香烟或个人用药品。

3.2.1. Temperature and environment control 温度和环境控制

Suitable equipment and procedures should be in place to check the environment where medicinal products are stored. Environmental factors to be considered include temperature, light, humidity and cleanliness of the premises.

药品存贮的地方，应具备有适当的设备和程序来检查存贮环境温度。要考虑的环境因素包括温度、照度、湿度和设施的清洁度。

An initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions. Temperature monitoring equipment should be located according to the results of the mapping exercise, ensuring that monitoring devices are positioned in the areas that experience the extremes of fluctuations. The mapping exercise should be repeated according to the results of a risk assessment exercise or whenever significant modifications are made to the facility or the temperature controlling equipment. For small premises of a few square meters which are at room temperature, an assessment of potential risks (e.g. heaters) should be conducted and temperature monitors placed accordingly.

存贮区域在投入使用前，应在具有代表性的条件下进行初始温度分布测试。温度监测设备应根据温度分布测试的结果进行放置，保证监测器具所处位置经历波动的极端值。应根据风险评估的结果重复温度分布测试。如果设施或温度控制设备经过了重大改造，也需要重复温度分布测试。对于室温条件下只有几个平方米的小面积设施，应进行潜在风险评估（例如加热器），并相应放置温度监控仪。

3.3. Equipment 设备

All equipment impacting on storage and distribution of medicinal products should be designed, located and maintained to a standard which suits its intended purpose. Planned maintenance should be in place for key equipment vital to the functionality of the operation.

所有对药品的存贮和销售产生影响的设备均应进行设计、定位和维护，以保持其适用于既定用途。应对操作功能具有重要作用的关键设备进行有计划的维护。

Equipment used to control or to monitor the environment where the medicinal products are stored should be calibrated at defined intervals based on a risk and reliability assessment.

用于控制或监测药品存贮环境的设备应定期进行校正，校正周期应基于风险和可靠性评估确定。

Calibration of equipment should be traceable to a national or international measurement standard. Appropriate alarm systems should be in place to provide alerts when there are excursions from pre-defined storage conditions. Alarm levels should be appropriately set and alarms should be regularly tested to ensure adequate functionality.

设备的校正应可以追溯到国家或国际测量标准。应配备适当的警报系统，当存贮条件超出预定范围时启动报警。要将报警值设定在适当水平，报警功能要定期进行测试以保证其运行正常。

Equipment repair, maintenance and calibration operations should be carried out in such a way that the integrity of the medicinal products is not compromised.

设备的维修、维护和校正操作不得影响药品的完整性。

Adequate records of repair, maintenance and calibration activities for key equipment should be made and the results should be retained. Key equipment would include for example cold stores, monitored intruder alarm and access control systems, refrigerators, thermo hygrometers, or other temperature and humidity recording devices, air handling units and any equipment used in conjunction with the onward supply chain.

关键设备的维修、维护和校正应有记录，结果需详细记录。关键设备包括如低温存贮区、监控报警系统、进出权限控制系统、冰箱、温湿度仪，或其它温湿度记录仪器、空调系统操作单元和用于连接后续供应链的所有设备。

3.3.1. Computerised systems 计算机化系统

Before a computerised system is brought into use, it should be demonstrated, through appropriate validation or verification studies, that the system is capable of achieving the desired results accurately, consistently and reproducibly.

计算机化系统在投入使用前，应通过适当的验证或确认研究，被证明系统有能力准确、持续并可重复地获得所需的结果。

A written, detailed description of the system should be available (including diagrams where appropriate). This should be kept up- to-date. The document should describe principles, objectives, security measures, system scope and main features, how the computerised system is used and the way it interacts with other systems.

系统应有一份详细的书面描述（适当时应包括图纸），且保持更新。该文件应包括原理、目的、安保措施、系统范围和主要特点，该计算机化系统如何使用，如何与其它系统相互作用。

Data should only be entered into the computerised system or amended by persons authorised to do so.

计算机化系统数据应只允许获得授权的人员进行输入或修改。

Data should be secured by physical or electronic means and protected against accidental or unauthorised modifications. Stored data should be checked periodically for accessibility. Data should be protected by backing up at regular intervals. Back up data should be retained for the period stated in national legislation but at least five years at a separate and secure location.

应有物理或电子方式对数据进行保护，以免事故性或未授权修改。已存贮的数据要周期检查其可用性。应周期性对数据进行备份，备份数据要按在一个独立且安全的地方存贮一定时长，时长应符合国家法规要求，但不应少于5年。

Procedures to be followed if the system fails or breaks down should be defined. This should include systems for the restoration of data.

应建立系统失败或崩溃时的处理程序，包括数据恢复系统。

3.3.2. Qualification and validation 确认和验证

Wholesale distributors should identify what key equipment qualification and/or key process validation is necessary to ensure correct installation and operation. The scope and extent of such qualification and/or validation activities (such as storage, pick and pack processes) should be determined using a documented risk assessment approach.

批发分销商应识别哪些关键设备和/或关键流程需要进行确认/验证，以保证正确的安装和操作。这些确认和/或验证活动（例如存贮、取货和包装流程）的范围和程度应采用书面的风险评估方法确定。

Equipment and processes should be respectively qualified and/or validated before commencing use and after any significant changes, e.g. repair or maintenance.

设备和流程在实际使用前，以及进行重大变更后，例如维修或维护，应分别进行确认和/或验证。

Validation and qualification reports should be prepared summarising the results obtained and commenting on any observed deviations. Deviations from established procedures should be documented and further actions decided to correct deviations and avoid their reoccurrence (corrective and preventive actions). The principles of CAPA should be applied where necessary. Evidence of satisfactory validation and acceptance of a process or piece of equipment should be produced and approved by appropriate personnel.

应制订验证和确认报告，对验证所得结果进行总结，对所有观察到的偏差进行评估。不符合预定程序的偏差应记录，进一步确定纠正措施，防止其再次发生（纠正措施和预防措施），必要时要使用CAPA原则。验证应生成工艺和设备验证符合可接受标准的证据，应由适当的人员批准。

CHAPTER 4 — DOCUMENTATION

第四章—文件记录

4.1. Principle 总则

Good documentation constitutes an essential part of the quality system. Written documentation should prevent errors from spoken communication and permits the tracking of relevant operations during the distribution of medicinal products.

良好的文件记录是质量体系的基本组成部分。书面的文件记录可以防止口头沟通的错误，使药品分销过程中的相关操作可以追溯。

4.2. General 通用要求

Documentation comprises all written procedures, instructions, contracts, records and data, in paper or in electronic form. Documentation should be readily available/retrievable.

文件记录由纸质或电子形式的书面程序、指令、合同、记录和数据组成。文件记录应易于获得/恢复。

With regard to the processing of personal data of employees, complainants or any other natural person, Directive 95/46/EC ([9]) on the protection of individuals applies to the processing of personal data and to the free movement of such data.

关于员工、投诉者或其它自然人的个人数据的处理和删除流程，适用指令95/46/EC关于个人保护的条款。

Documentation should be sufficiently comprehensive with respect to the scope of the wholesale distributor’s activities and in a language understood by personnel. It should be written in clear, unambiguous language and be free from errors.

文件记录应包含足够的内容，能反映批发分销商的活动范围，应采用员工能懂的语言。其用词应清晰，不应模棱两可，不应有错误。

Procedure should be approved signed and dated by the responsible person. Documentation should be approved, signed and dated by appropriate authorised persons, as required. It should not be hand-written; although, where it is necessary, sufficient space should be provided for such entries.

程序应由负责人签字并注明日期进行批准。文件记录应由经过具有适当授权的人员批准，签名并注明日期。必要时，应留出足够的空白/空间给这些签名日期。

Any alteration made in the documentation should be signed and dated; the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded.

对文件记录的修改均需签名并注明日期，修改后原始信息应保持可读。适当时，还需要记录修改的原因。

Documents should be retained for the period stated in national legislation but at least five years. Personal data should be deleted or anonymised as soon as their storage is no longer than necessary for the purpose of distribution activities.

文件记录保存期限应符合国家法规要求，并不得少于5年。分销活动不再需要的个人数据，可以删除或隐去名字。

Each employee should have ready access to all necessary documentation for the tasks executed.

每个员工都应具有权限获得其工作所需的文件记录。

Attention should be paid to using valid and approved procedures. Documents should have unambiguous content; title, nature and purpose should be clearly stated. Documents should be reviewed regularly and kept up-to-date. Version control should be applied to procedures. After revision of a document, a system should exist to prevent inadvertent use of the superseded version. Superseded or obsolete procedures should be removed from workstations and archived.

注意要采用经过批准的有效程序。文件记录应有清楚的内容、标题，清楚说明其目的。文件应进行定期审核，保证其时效性。对所有程序要实施版本控制。在文件修订后，系统应能防止使失效版本的程序。前版本或失效程序应从工作场所和存档中移除。

Records must be kept either in the form of purchase/sales invoices, delivery slips, or on computer or any other form, for any transaction in medicinal products received, supplied or brokered.

所有收到、销售或转销的药品交易信息记录应保存，可以是采购/销售发标、发运单，可以采用计算机，也可以采用其它形式保存。

Records must include at least the following information: date; name of the medicinal product; quantity received, supplied or brokered; name and address of the supplier, customer, broker or consignee, as appropriate; and batch number at least for medicinal product bearing the safety features ([10] ).

记录必须至少包括以下信息：日期、药品名称、收到/销售或转销数量、供应商/客户/中间商或承运人名称和地址，适当时，还应有具有安全信息的药品批号。

Records should be made at the time each operation is undertaken.

每次操作均应及时记录。

---

[1] Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, p. 67.

[2] Guidelines on Good Distribution Practice of medicinal products for human use, OJ C 63, 1.3.1994, p. 4.

[3] Guidelines of 7 March 2013 on Good Distribution Practice of medicinal products for human use, OJ C 68, 8.3.2013, p. 1.

[4] Directive 2011/62/EU of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products, OJ L 174, 1.7.2011, p. 74.

[5] Article 80(h) of Directive 2001/83/EC.

[6] Article 79(b) of Directive 2001/83/EC.

[7] Article 83 of Directive 2001/83/EC.

[8] Article 79(a) of Directive 2001/83/EC.

[9] OJ L 281, 23.11.1995, p. 31.

[10] Article 80(e) and Article 82 of Directive 2001/83/EC.


转自Julia博客

药仙

我们的坛友就像茫茫沙海中的一粒沙子和浩瀚森林中的一片叶舟，假如都向楼主一样无私进取的话-----那是一种何等壮观场面{:soso_e122:}
能力来自一沙积累
财富仰仗一叶菩提{:soso_e183:}

yuansoul

5.5 和6.3 木有看见啊。

yuansoul

药仙 发表于 2014-7-8 09:23
我们的坛友就像茫茫沙海中的一粒沙子和浩瀚森林中的片叶舟，假如都向楼主一样无私进取的话-----那是一种何等 ...

沙子来源于粉碎的石头，顽石来源于高山，高山来源于地壳运动。所以，做好各种运动，特别是讨论发帖规范的技术运动可以从源头上提高。但是呢，从另一个角度来说，任何时候都要听领导的。所以，需要开会解决论坛发展问题。

药仙

yuansoul 发表于 2014-7-8 09:39
沙子来源于粉碎的石头，顽石来源于高山，高山来源于地壳运动。所以，做好各种运动，特别是讨论发帖规范的 ...

鹅曲径天歌，人赎罪吹乐，太空多空彻

一沙一叶

药仙 发表于 2014-7-8 09:23
我们的坛友就像茫茫沙海中的一粒沙子和浩瀚森林中的片叶舟，假如都向楼主一样无私进取的话-----那是一种何等 ...

不敢当，不敢当。我只是转载。。。。

郝小琴

谢谢蒲友de分享

xqliu

学习一下啦，谢谢提供分享。