7月7日，欧盟委员会和PIC/S均发布了新的GMP修订：包括正文第4章《文件记录》、附录11《计算机化系统》和一个新的附录——附录22《人工智能》，如下：

附录11《计算机化系统》已翻译完成，详见新版欧盟/PIC/S GMP附录11《计算机化系统》（中英文对照）

第四章 文件记录 翻译 如下：

Chapter 4: Documentation

第四章：文件记录
Document map文件目录
Principle原则

Data governance systems数据治理系统

Risk management风险管理

General requirements for documentation文件记录的一般要求

Master Documents主文件

Generation and Control of Documentation文件记录的生成与控制

Good documentation practice良好文件记录规范

Signatures in GMP relevant documentationGMP 相关文件中的签名

Retention of documents文件保存

Data Integrity in documentation文件记录中的数据完整性

Hybrid Systems混合系统

Glossary术语

 

PRINCIPLE
原则

4.1 Documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements. The various types of documents and means used should be fully understood and defined in the regulated user's pharmaceutical quality system.
4.1 文件记录是质量保证体系的重要组成部分，也是符合GMP要求运营的关键。受监管用户的药品质量体系中应充分理解和定义所使用的各类文件和方式。

4.2 It should be determined by the regulated user which legal provisions apply to documentation considering new technologies, hybrid solutions and services used.
4.2 受监管用户应考虑所使用的新技术、混合解决方案和服务，确定哪些法律规定适用于文件记录。

4.3 Appropriate documentation practices should be applied with respect to the type of document regardless of the applied technology or service used.
4.3 应根据文件类型采用适当的文件记录做法，无论所应用的技术或服务如何。

4.4 The present document was supplemented with requirements regarding new technologies, hybrid solutions and new services, whereby a risk - based approach as element of a data governance system is considered pivotal for scalability of control measures.
4.4 本文件补充了关于新技术、混合解决方案和新服务的要求，其中基于风险的方法作为数据治理系统的要素，被认为对控制措施的可扩展性至关重要。

4.5 Quality risk management principles should be applied to ensure that the pharmaceutical quality system includes sufficient instructional details. It should facilitate a common understanding of the requirements. In addition to providing for recording of the various processes and risk - based evaluation of any observations, it should demonstrate the onerous application of all requirements.
4.5 应使用质量风险管理原则，以确保药品质量体系包含足够的指导性细节。它应有助于对要求形成共同理解。除了记录各种过程和对任何观察结果进行基于风险的评估外，还应证明所有要求都得到了严格应用。

4.6 Suitable controls should be implemented using a risk - based approach to ensure the accuracy, integrity, availability, and legibility of documents. Documents should be free from errors and available in human - readable form.
4.6 应采用基于风险的方法实施适当的控制措施，以确保文件的准确性、完整性、可用性和易读性。文件应无错误且以人类可读的形式提供。

4.7 Documentation may exist in a variety of forms, including paper - based, electronic, or other means (e.g., photography; imagery, video, and audio recordings). The main objective of the documentation system is to establish, control, monitor and record all activities which directly or indirectly impact on all aspects of the quality and safety of medicinal products, using a risk - based approach.
4.7 文件记录可能以多种形式存在，包括纸质、电子或其他方式（例如，摄影；图像、视频和音频记录）。文件记录系统的主要目标是使用基于风险的方法，建立、控制、监测和记录直接或间接影响药品质量和安全各个方面的所有活动。

4.8 Whether documents are created, stored, and managed electronically, paper - based, by other means or through a hybrid system, they must meet the same GMP requirements for legibility, accuracy, integrity, and completeness throughout the whole lifecycle. This also applies when documentation is outsourced.
4.8 无论文件是以电子方式、纸质方式、其他方式还是通过混合系统创建、存储和管理，它们在整个生命周期内都必须满足相同的GMP 要求，即易读性、准确性、完整性和完整性。这在外包文件记录时同样适用。

4.9 There are two primary types of documentation used to manage and demonstrate GMP compliance:
4.9 有两种主要类型的文件记录用于管理和证明符合GMP 要求：

i. instructions (directions, requirements) and
i. 指令（说明、要求）和

ii. records/reports.
ii. 记录/ 报告。

 

DATA GOVERNANCE SYSTEMS
数据治理系统

4.10 Regardless of how documents are created, handled, stored, and managed (i.e., using electronic, paper - based, or hybrid systems), the regulated user should establish a data governance system integral to the pharmaceutical quality system to define, prioritise and communicate their data integrity risk management activities. Arrangements for data governance should be documented and reviewed regularly.
4.10 无论文件是如何创建、处理、存储和管理的（即使用电子、纸质或混合系统），受监管用户都应建立一个与药品质量体系相结合的数据治理系统，以定义、确定优先级并传达其数据完整性风险管理活动。应有书面的数据治理安排并定期审查。

4.11 Regulated users should design and operate a data governance system which provides an acceptable state of control based on the risk assessment, which is documented with supporting rationale. A data governance system should be consistent with the principles of quality risk management.
4.11 受监管用户应设计和运行一个数据治理系统，该系统基于风险评估提供可接受的控制状态，并记录有支持性理由。数据治理系统应符合质量风险管理原则。

4.12 To ensure integrity of data the governance system should cover the entire data lifecycle and ensure controls to communicate with the principle of quality risk management. The data lifecycle should refer to:
4.12 为确保数据完整性，治理系统应涵盖整个数据生命周期，并确保控制措施与质量风险管理原则相一致。数据生命周期应涉及：

i. Creation and recording of data.
i. 数据的创建和记录。

ii. Processing (raw) data to reported (derived) data.
ii. 将（原始）数据处理为报告（派生）数据。

iii. Verification of completeness, consistency and accuracy of all data (raw and derived data). For derived data the traceability which allows reconstruction of all data - processing activities should be maintained.
iii. 验证所有数据（原始数据和衍生数据）的完整性、一致性和准确性。对于衍生数据，应保持可追溯性，以便能够重现所有数据处理活动。

iv. Decision making relying on data (or derived data).
iv. 基于数据（或衍生数据）进行决策。

v. Retaining, archiving and retrieval of data. To protect it from loss or unauthorised al - teration, it should be commensurate with the principles of quality risk management.
v. 数据的保留、存档和检索。为防止数据丢失或未经授权的更改，其操作应符合质量风险管理原则。

vi. Retirement or destruction of data at the end of the life - cycle in a controlled manner.
vi. 在生命周期结束时，以受控方式停用或销毁数据。

4.13 Data governance systems should rely on a risk management approach and consider:
4.13 数据治理系统应依赖风险管理方法，并考虑：

i. Data criticality (impact to decision making and product quality).
i. 数据关键性（对决策制定和产品质量的影响）。

ii. Data risk (opportunity for data alteration and deletion, and likelihood of detection /visibility of changes by the regular user's routine review processes).
ii. 数据风险（数据被更改和删除的可能性，以及常规用户日常审查流程检测到/ 发现更改的可能性）。

4.14 Data governance systems should rely on the incorporation of well - designed systems, the use of technologies and security measures, combined with specific expertise to ensure that data integrity is effectively controlled over the data life - cycle.
4.14 数据治理系统应依靠设计良好的系统、技术和安全措施的结合，并辅以特定的专业知识，以确保在数据生命周期内有效控制数据完整性。

4.15 Data governance systems should address data ownership throughout the entire life - cycle.
4.15 数据治理系统应在整个生命周期内明确数据所有权。

4.16 Data governance systems should consider the design, operation and monitoring of processes and systems to comply with the principles of integrity.
4.16 数据治理系统应考虑流程和系统的设计、运行和监控，以符合完整性原则。

4.17 Data governance systems should consider risk mitigation. The effectiveness of risk mitigation measures should be reviewed regularly, regardless of whether they are temporary or perma - nent. Residual risks should be reviewed periodically and communicated to management.
4.17 数据治理系统应考虑风险缓解措施。无论风险缓解措施是临时的还是永久的，都应定期审查其有效性。应定期审查残余风险并向管理层报告。

4.18 Data governance systems should consider and ensure the periodic review of service provider's data management policies and risk control strategies intended to minimise potential risks to data integrity. The frequency of such reviews should be based on the criticality of the services provided, using risk management principles.
4.18 数据治理系统应考虑并确保定期审查服务提供商的数据管理政策和风险控制策略，以尽量减少数据完整性的潜在风险。此类审查的频率应根据所提供服务的关键性，运用风险管理原则来确定。

 

RISK MANAGEMENT
风险管理

4.19 The regulated user should adopt a risk - based approach in documentation throughout the entire life - cycle of data, regardless of the technology, hybrid solution or service used and should demonstrate an understanding of data criticality, data risk and data quality.
4.19 受监管的用户应在数据的整个生命周期内，无论使用何种技术、混合解决方案或服务，都采用基于风险的方法进行记录，并应证明对数据关键性、数据风险和数据质量的理解。

4.20 Controls over data life - cycle should be established which are commensurate with the prin - ciples of quality risk management. The depth of data governance and risk management activ - ities should be justified and commensurate with the risks to product quality and patient safety.
4.20 应建立与质量风险管理原则相符的数据生命周期控制措施。数据治理和风险管理活动的深度应合理，并与对产品质量和患者安全的风险相称。

4.21 Decisions on the extent of measures to ensure data integrity should be based on a documented rationale and documented risk assessment taking into consideration data criticality and data risk.
4.21 确保数据完整性的措施范围的决策应基于有记录的理由和记录的风险评估，并考虑数据关键性和数据风险。

4.22 Irrespective of processes used to generate electronic data, they must be included in the re - quirements for the qualification or validation of the relevant computerised systems according to Annex 11.
4.22 无论用于生成电子数据的过程如何，都必须根据附录11 将其纳入相关计算机化系统的确认或验证要求中。

 

GENERAL REQUIREMENTS FOR DOCUMENTATION
文件记录的一般要求

4.23 The pharmaceutical quality system should describe all documents required to ensure product quality and patient safety. Documents maybe created, recorded, provided, approved, commu - nicated, stored, and archived electronically, paper - based or in a hybrid system. The reliance on electronic, paper - based or different means, hybrid solutions with hosted services in main - tenance and retention of documentation requires the compliance with all EU GMP provisions including Annex 11 if decision making in manufacturing (e.g. batch release based on in - pro - cess controls and process analytical technologies) is supported by automatic validation scripts.
4.23 药品质量体系应描述确保产品质量和患者安全所需的所有文件。文件可以以电子、纸质或混合系统的形式创建、记录、提供、批准、传达、存储和存档。在制造过程中的决策（例如，基于过程控制和过程分析技术的批次放行）由自动验证脚本支持的情况下，在文件的维护和保留方面依赖电子、纸质或不同方式、托管服务的混合解决方案，需要符合所有欧盟GMP规定，包括附录11。

4.24The accountability for the integrity of documents, records or (raw)data produced or processed with artificial intelligence or any other automatic means (e.g. validation scripts) rests with the regulated user.4.24 对于使用人工智能或任何其他自动手段（例如验证脚本）生成或处理的文件、记录或（原始）数据的完整性，责任在于受监管用户。

4.25. The support by any automatic means (e.g. validation scripts or artificial intelligence) should be included in a pharmaceutical quality system regardless of the service located on premise or as a hosted service.
任何自动手段（例如验证脚本或人工智能）的支持都应纳入药品质量体系，无论该服务是本地服务还是托管服务。

The records created electronically should enable a trend analysis of quality - critical data.
电子创建的记录应能够对质量关键数据进行趋势分析。

4.26. To ensure data integrity, data which is recorded or processed electronically should not be converted to or stored in a paper form unless it meets the requirements set out in section 13 “hybrid systems” or the conversion is validated or verified for accuracy.
为确保数据完整性，以电子方式记录或处理的数据不应转换为纸质形式或存储在纸质介质中，除非其符合第13 节“混合系统” 中规定的要求，或者转换已针对准确性进行了验证或核实。

 

MASTER DOCUMENTS
主文件

4.27. Specifically required master documents (not exhaustive list):
4.27. 特别要求的主文件（非详尽列表）：

i. Site Master File: Refer to EU GMP Guidelines, Volume 4 “Explanatory Notes on the preparation of a Site Master File”.
i. 场地主文件：参考欧盟GMP 指南，第4 卷“场地主文件编制解释说明”。

ii. Validation Master Plan: A document describing the key elements of the site qualification and validation program. Master documents should be evaluated and reviewed on a regular basis.
ii. 验证主计划：一份描述场地确认和验证计划关键要素的文件。主文件应定期进行评估和审核。

iii. Instruction (directions, or requirements) type:
iii. 指令（指示或要求）类型：

——Specification: Refer to glossary for definition
质量标准：定义见术语表

——Manufacturing Formulae, Processing, Packaging and Testing Instruction: Provide complete detail on all the starting materials, equipment, and computerised systems (if any) to be used and specify all processing, packaging, sampling, and testing instructions to ensure batch to batch consistency. In - process controls and relevant analytical techniques to be employed should be specified where relevant, together with acceptance criteria.
制造配方、加工、包装和测试指令：提供所有将使用的起始物料、设备和计算机化系统（如有）的完整详细信息，并指定所有加工、包装、取样和测试指令，以确保批次间的一致性。应在相关情况下指定要采用的过程控制和相关分析技术以及验收标准。

——Procedures: (Otherwise known as Standard Operating Procedures, or SOPs), documented set of instructions for performing and recording operations.
规程：（也称为标准操作规程，即SOP），执行和记录操作的文件化指令集。

——Protocol: defined set of activities to provide instructions for performing and recording certain discreet operations.
方案：为执行和记录某些特定操作提供指令的一组定义的活动。

——Technical / Quality Agreement: Written proof of agreement between contract givers and acceptors for outsourced activities.
技术/ 质量协议：外包活动中合同授予方和接受方之间协议的书面证明。

iv. Record/Report type:
iv. 记录/ 报告类型：

——Record: Provide evidence of various actions taken to demonstrate compliance with instructions, e.g. activities, events, investigations, and in the case of manufactured batches a history of each batch of product, including its distribution. Records include the raw data which is used to generate other records. For electronic records regulated users should define which data are to be used as raw data. At least, all data on which quality decisions are based should be defined as raw data.
记录：提供为证明符合指令而采取的各种行动的证据，例如活动、事件、调查，对于生产批次，还包括每批产品的历史记录，包括其分销情况。记录包括用于生成其他记录的原始数据。对于受监管的电子记录用户，应定义哪些数据将用作原始数据。至少，所有作为质量决策依据的数据都应定义为原始数据。

——Certificate of Analysis: Provide a summary of testing results on samples of products or materials' together with the evaluation for compliance to a stated specification.
分析证书：提供产品或材料样品测试结果的摘要，以及对是否符合规定规格的评估。

——Report: Document the conduct of exercises, studies, assessments, projects or investigations, together with results, conclusions and recommendations.
报告：记录演习、研究、评估、项目或调查的开展情况，以及结果、结论和建议。

Specifications
质量标准

4.28. There should be approved and updated specifications for starting and packaging materials, intermediate, bulk, finished products, process aids and other quality critical material, as applicable. Specifications should include all attributes which are relevant for product quality on each stage of material or manufacture.
4.28. 对于起始物料和包装材料、中间体、待包装产品、成品、工艺助剂及其他关键质量物料（如适用），应有经批准且更新的质量标准。质量标准应包括物料或生产各阶段与产品质量相关的所有属性。

Specifications for starting and packaging materials
起始物料和包装材料的质量标准

4.29. Specifications for starting and primary or printed packaging materials should include the product and its reference code, if applicable;
4.29. 起始物料和主要或印刷包装材料的质量标准应包括产品及其参考代码（如适用）；

i. A description of the materials, including:
i. 物料描述，包括：

The designated name and the internal code reference.
指定名称和内部代码参考。      The reference, if any, to a pharmacopoeial monograph.
 药典专论的参考（如有）。      The approved supplier, and, if applicable, the original producer of the material.
 经批准的供应商，以及（如适用）物料的原始生产商。      A specimen of printed materials.
印刷材料样本。

ii. Directions for sampling and testing.
ii. 取样和测试说明。

iii. Qualitative and quantitative requirements with acceptance limits.
iii. 带有可接受限度的定性和定量要求。

iv. Storage conditions and precautions.
iv. 储存条件和预防措施。

v. The maximum period of storage before re - examination.
v. 重新检验前的最长储存期限。

Specifications for intermediate and bulk products
中间体和待包装产品的质量标准

4.30. Specifications for intermediate and bulk products should be available for critical steps or if these are purchased or dispatched. The specifications should be similar to specifications for starting materials or for finished products, as appropriate.
4.30. 对于关键步骤的中间体和待包装产品，或在采购或发运时，应有质量标准。这些质量标准应根据情况类似于起始物料或成品的质量标准。

Specifications for finished products
成品的质量标准

4.31. Specifications for finished products should include or provide reference to:
4.31. 成品的质量标准应包括或提及：

vi. The designated name of the product and the code reference where applicable.
vi. 产品的指定名称及适用的代码参考。

vii. The formula.
vii. 配方。

viii. A description of the pharmaceutical form and package details.
viii. 剂型和包装细节描述。

ix. Directions for sampling and testing.
ix. 取样和测试说明。

x. The qualitative and quantitative requirements, with the acceptance limits.
x. 带有可接受限度的定性和定量要求。

xi. The storage conditions and any special handling precautions, where applicable.
xi. 储存条件和任何特殊处理预防措施（如适用）。

xii. The shelf - life.
xii. 保质期。

Manufacturing Formula and Processing Instructions
生产配方和工艺规程

4.32. Approved, written Manufacturing Formula and Processing Instructions should exist for each product and batch size to be manufactured.
4.32. 对于每个要生产的产品和批次规模，应有经批准的书面生产配方和工艺规程。

4.33. The Manufacturing Formula should include:
4.33. 生产配方应包括：

i. The name of the product, with a product reference code relating to its specification.
i. 产品名称，以及与其规格相关的产品参考代码。

ii. A description of the pharmaceutical form, strength of the product and batch size.
ii. 剂型、产品规格和批量的描述。

iii. A list of all starting materials to be used, with the amount of each, described;
iii. 所用所有起始物料的清单，并注明每种物料的用量；

mention should be made of any substance that may disappear while processing, of processing aids needed or any other material relevant for product quality.
应提及在加工过程中可能消失的任何物质、所需的加工助剂或与产品质量相关的任何其他材料。

iv. A statement of the expected final yield with the acceptable limits, and of relevant in - termediate yields, where applicable.
iv. 预期最终产量及其可接受限度的说明，以及适用时相关中间产量的说明。

4.34. The Processing Instructions should include:
4.34. 工艺规程应包括：

i. A statement of the processing location and the principal equipment to be used.
i. 所用加工地点和主要设备的说明。

ii. The methods, or reference to the methods, to be used for preparing the critical equipment (e.g. cleaning, assembling, calibrating, sterilising).
ii. 用于准备关键设备的方法，或对这些方法的引用（如清洁、组装、校准、灭菌）。

iii. Checks that the equipment and workstation are clear of previous products, documents or materials not required for the planned process, and that equipment is clean and suitable for use.
iii. 检查设备和工作站是否无先前产品、计划工艺不需要的文件或材料，且设备清洁并适合使用。

iv. Detailed step - wise processing instructions [e.g. checks on materials, pre - treatments, sequence for adding materials, critical process parameters (time, temp etc)].
iv. 详细的分步加工说明[如物料检查、预处理、添加物料的顺序、关键工艺参数（时间、温度等）]。

v. The instructions for any in - process controls with their limits.
v. 任何过程控制及其限度的说明。

vi. Where necessary, the requirements for bulk storage of the products; including the container, labelling and special storage conditions where applicable.
vi. 必要时，产品批量储存的要求；包括容器、标签以及适用时的特殊储存条件。

vii. Any special precautions to be observed.
vii. 需遵守的任何特殊预防措施。

Packaging Instructions
包装规程

4.35. Approved Packaging Instructions for each product, pack size and type should exist. These should include, or have a reference to, the following:
4.35. 每种产品、包装尺寸和类型都应有经批准的包装规程。这些规程应包括或引用以下内容：

i. Name of the product; including the batch number of bulk and finished product.
i. 产品名称；包括散装和成品的批号。

ii. Description of its pharmaceutical form, and strength where applicable.
ii. 其药物形式的描述，以及适用时的规格。

iii. The pack size expressed in terms of the number, weight or volume of the product in the final container.
iii. 以最终容器中产品的数量、重量或体积表示的包装尺寸。

iv. A complete list of all the packaging materials required, including quantities, sizes and types, with the code or reference number relating to the specifications of each packaging material.
iv. 所需所有包装材料的完整清单，包括数量、尺寸和类型，以及与每种包装材料规格相关的代码或参考编号。

v. Where appropriate, an example or reproduction of the relevant printed packaging materials, and specimens indicating where to apply batch number references, and shelf life of the product.
v. 适当时，相关印刷包装材料的示例或复制品，以及标明批号引用位置和产品保质期的样本。

vi. Checks that the equipment and workstation are clear of previous products, documents or materials not required for the planned packaging operations (line clear - ance), and that equipment is clean and suitable for use.
vi. 检查设备和工作站是否无先前产品、计划包装操作不需要的文件或材料（生产线清洁），且设备清洁并适合使用。

vii. Checks on functioning of any electronic code readers, label counters or similar devices.
vii. 检查任何电子读码器、标签计数器或类似设备的功能。

viii. Special precautions to be observed, including a careful examination of the area and equipment in order to ascertain the line clearance before operations begin.
viii. 需遵守的特殊预防措施，包括在操作开始前仔细检查区域和设备以确定生产线清洁。

ix. A description of the packaging operation, including any significant subsidiary operations, and equipment to be used.
ix. 包装操作的描述，包括任何重要的辅助操作以及要使用的设备。

x. Details of in - process controls with instructions for sampling and acceptance limits.
x. 过程控制的详细信息，包括取样和验收限度的说明。

Batch Processing Record
批生产记录

4.36. A Batch Processing Record should be kept for each batch processed. It should be based on the relevant parts of the currently approved Manufacturing Formula and Processing Instructions, and should contain the following information.
4.36. 每批加工产品都应保存批次加工记录。该记录应基于当前已批准的生产配方和工艺规程的相关部分，并应包含以下信息。

i. The name and batch number of the product.
i. 产品名称和批号。

ii. Dates and times of commencement, of significant intermediate stages and of completion of production.
ii. 生产开始、重要中间阶段和完成的日期和时间。

iii. Identification (initials) of the operator (s) who performed each significant step of the process and, where appropriate, identification (initials) of the person who checked these operations.
iii. 执行该过程每个重要步骤的操作人员的标识（姓名首字母），并在适当情况下，对这些操作进行检查的人员的标识（姓名首字母）。

iv. The batch number and/or analytical control number as well as the quantities of each starting material weighed (including the batch number and amount of any recovered or reprocessed material added).
iv. 批号和/ 或分析控制编号，以及每种起始物料的称重数量（包括任何回收或再加工物料的批号和添加量）。

v. Any relevant processing operation or event and major equipment used.
v. 任何相关的加工操作或事件以及使用的主要设备。

vi. A record of the in - process controls and the initials of the person (s) carrying them out, and the results obtained.
vi. 过程控制记录以及执行控制人员的姓名首字母，以及所获得的结果。

vii. The product yields obtained at different and pertinent stages of manufacture.
vii. 在不同且相关的生产阶段获得的产品收率。

viii. Notes on special problems including details, with signed authorization for any deviation from the Manufacturing Formula and Processing Instructions.
viii. 关于特殊问题的说明，包括详细信息，以及对任何偏离生产配方和工艺规程的签署授权。

ix. Approval by the person responsible for the processing operations.
ix. 由负责加工操作的人员批准。

Note: Where a validated process is continuously monitored and controlled, then automatically generated reports may be limited to compliance summaries and exception/out - of - specification (OOS) data reports.
注意：如果经过验证的过程受到持续监控和控制，则自动生成的报告可能仅限于合规性总结以及异常/ OOS数据报告。

With regards to decision making in manufacturing supported by automatic validation scripts or artificial intelligence refer to paragraph 4 of this document.
关于由自动验证脚本或人工智能支持的生产决策，请参阅本文件第4 段。

Batch Packaging Record
批包装记录

4.37. A Batch Packaging Record should be kept for each batch or part batch processed. It should be based on the relevant parts of the Packaging Instructions.
4.37. 应对每个加工的批次或部分批次保存批次包装记录。该记录应基于包装规程的相关部分。

4.38. The batch packaging record should contain the following information:
4.38. 批次包装记录应包含以下信息：

i. The name and batch number of the product.
i. 产品名称和批号。

ii. The date (s) and times of the packaging operations.
ii. 包装操作的日期和时间。

iii. Identification (initials) of the operator (s) who performed each significant step of the process and, where appropriate, the name of any person who checked these operations.
iii. 执行该过程每个重要步骤的操作人员的标识（姓名首字母），并在适当情况下，对这些操作进行检查的人员的姓名。

iv. Records of checks for identity and conformity with the packaging instructions, including the results of in - process controls.
iv. 对与包装规程的一致性和相符性的检查记录，包括过程控制结果。

v. Records of checks that the equipment and workstation are clear of previous products, documents or materials not required for the planned packaging operations (line clearance), that equipment is clean and suitable for use, and that any electronic code readers, label counters or similar devices are functioning as expected.
v. 检查记录，确保设备和工作站无计划包装操作不需要的先前产品、文件或材料（清场），设备清洁且适合使用，并且任何电子扫码器、标签计数器或类似设备按预期运行。

vi. Details of the packaging operations carried out, including references to equipment and the packaging lines used.
vi. 所进行的包装操作的详细信息，包括对所用设备和包装生产线的参考。

vii. Whenever possible, samples of printed packaging materials used, including specifications of the batch coding, expiry dating and any additional overprinting.
vii. 只要可能，所用印刷包装材料的样品，包括批次编码、有效期和任何额外套印的规格。

viii. Notes on any special problems or unusual events including details, with signed authorization for any deviation from the packaging instructions.
viii. 关于任何特殊问题或异常事件的说明，包括详细信息，以及对任何偏离包装规程的签署授权。

ix. The quantities and reference number or identification of all printed packaging materials and bulk product issued, used, destroyed or returned to stock and the quantities of obtained product, to provide for an adequate reconciliation. Where there are vali - dated electronic controls in place during packaging there may be justification for not including this information.
ix. 所有已发放、使用、销毁或退回库存的印刷包装材料和散装产品的数量、参考编号或标识，以及所获得产品的数量，以便进行充分的核对。在包装过程中如果有经过验证的电子控制，可能有理由不包含此信息。

x. Approval by the person responsible for the packaging operations.
x. 由负责包装操作的人员批准。

Receipt
接收

4.39. There should be written procedures and records for the receipt of each delivery of each starting material, (including bulk, intermediate or finished goods), primary, secondary and printed packaging materials and QC - samples. The records of the receipts should include:
4.39. 对于每批起始物料（包括散装、中间体或成品）、内包装、外包装和印刷包装材料以及质量控制样品的接收，应有书面程序和记录。接收记录应包括：

i. The name of the material and the delivery notes and the containers.
i. 物料名称、送货单和容器。

ii. The “in - house” name or/and code of material (if different from a).
ii. 物料的“内部” 名称或/ 和代码（如果与i 不同）。

iii. Date of receipt.
iii. 接收日期。

iv. Supplier’s name and, manufacturer’s name.
iv. 供应商名称和制造商名称。

v. Manufacturer’s batch or reference number.
v. 制造商的批次或参考编号。

vi. Total quantity and number of containers received.
vi. 接收的总数量和容器数量。

vii. The batch number assigned after receipt.
vii. 接收后分配的批次号。

viii. Any relevant comment.
viii. 任何相关评论。

ix. If applicable, proof of verification that temperature during transportation were within the approved limit.
ix. 如适用，运输过程中温度在批准范围内的验证证据。

4.40. There should be written procedures for the internal labelling, quarantine and storage of start - ing materials, packaging materials, QC samples and other materials, as appropriate.
4.40. 应有适当的书面程序，用于起始物料、包装材料、质量控制样品和其他物料的内部标识、待检和存储。

Sampling
取样

4.41. There should be written procedures for sampling, which include the methods and equipment to be used, the amounts to be taken and any precautions to be observed to avoid contamination of the material or any deterioration in its quality (reference to EU GMP Guideline Volume 4, Chapter 6 “Quality Control”).
4.41. 应有书面的取样程序，包括所使用的方法和设备、取样量以及为避免物料污染或质量下降而应遵守的任何预防措施（参考EU GMP第4 卷，第6 章“质量控制”）。

Testing
测试

4.42. There should be written procedures for testing materials and products at different stages of manufacture, describing the methods and equipment to be used. The tests performed should be recorded (reference to EU GMP Guideline Volume 4, Chapter 6 “Quality Control”).
4.42. 应有书面程序，用于在生产的不同阶段对物料和产品进行测试，描述所使用的方法和设备。所进行的测试应记录在案（参考EU GMP第4 卷，第6 章“质量控制”）。

Other
其他

4.43. Written release and rejection procedures should be available for materials and products, and in particular for the certification for sale of the finished product by the Qualified Person (s). All records should be available to the Qualified Person at the time of the release decision. A system should be in place to indicate special observations and any changes to critical data.
4.43. 应有物料和产品的书面放行和拒收程序，特别是由有资质人员对成品销售的认证程序。在做出放行决定时，所有记录应可供有资质人员查阅。应建立一个系统，以表明特殊观察结果和关键数据的任何变化。

4.44. Records should be maintained for the distribution of each batch of a product in order to facili - tate recall of any batch, if necessary.
4.44. 应保存每批产品的分销记录，以便在必要时便于召回任何批次。

4.45. There should be written policies, procedures, protocols, reports and the associated records of actions taken, or conclusions reached, where appropriate, for GMP relevant actions, including but not limited to the following examples:
4.45. 对于与GMP相关的行动，应有书面政策、程序、方案、报告以及所采取行动的相关记录，或在适当情况下达成的结论,包括但不限于以下示例：

i. Validation and qualification of processes, equipment and systems.
工艺、设备和系统的验证与确认。

ii. Equipment assembly and calibration.
设备组装与校准。

iii. Data integrity.
数据完整性。

iv. Technology transfer.
技术转移。

v. Maintenance, cleaning and sanitation.
维护、清洁与卫生。

vi. Personnel matters including signature lists, training in GMP and technical matters, clothing and hygiene and verification of the effectiveness of training.
人员相关事宜，包括签名清单、GMP 及技术事项培训、着装与卫生以及培训有效性的验证。

vii. Environmental monitoring.
环境监测。

viii. Pest control.
虫害控制。

ix. Complaints.
投诉。

x. Recalls.
召回。

xi. Returns.
退货。

xii. Change control.
变更控制。

xiii. Investigations into deviations.
偏差调查。

xiv. non - conformances e.g. out of specifications.
不符合项，例如规格不符。

xv. Internal quality/GMP compliance audits.
内部质量/ GMP 合规审计。

xvi. Summaries of records where appropriate (e.g. product quality review).
适当情况下的记录汇总（如产品质量回顾）。

xvii. Supplier audits.
供应商审计。

4.46 Clear operating procedures should be available for all testing, manufacturing and test equipment.
4.46 对于所有检测、生产和测试设备，都应有清晰的操作规程。

4.47 Logbooks should be kept for major or critical analytical items, production equipment, and areas where product has been processed or handled. They should be used to record in chronological order, as appropriate, any use of the area, equipment/method, calibrations, maintenance, cleaning or repair operations, including the dates and identity of people who carried these operations out.
4.47 对于主要或关键的分析项目、生产设备以及产品加工或处理的区域，应保存日志。日志应按时间顺序记录该区域、设备/ 方法的使用情况、校准、维护、清洁或维修操作，包括执行这些操作的日期和人员身份。

4.48 An inventory of controls within the pharmaceutical quality system should be maintained.
4.48 应维护药品质量体系内的控制清单。

4.49 All types of documents (instructions and/or records) should be defined and adhered to regardless of the documentation technology, hybrid solution or service. The technology, hybrid solution or provided service needs to be understood regardless of complexity, should be adequately documented, and validated with risk - based controls in place. Relationships and control measures for master documents, official copies, data handling and records need to be defined for both hybrid and homogenous systems regardless of the type of service. Appropriate controls for documents should be implemented to ensure the completeness, integrity and legibility of the records throughout the lifecycle.
4.49 无论采用何种文件编制技术、混合解决方案或服务，所有类型的文件（规程和/ 或记录）都应明确并遵守。无论复杂程度如何，都应了解所采用的技术、混合解决方案或提供的服务，应进行充分记录，并通过基于风险的控制进行验证。对于混合系统和同质系统，无论服务类型如何，都应定义主文件、正式副本、数据处理和记录的关系及控制措施。应实施适当的文件控制，以确保记录在整个生命周期内的完整性、准确性和可读性。

4.50. Documents should be designed, prepared, reviewed, and distributed in a controlled manner. They should comply with the relevant parts of Product Specification Files Manufacturing and Marketing Authorisation dossiers, or dossiersof Investigational Medicinal Products, as appropriate. The reproduction of working documents from master documents should not allow any error or alteration to be introdueed through the reproduction process.

4.50. 文件的设计、编制、审核和分发应受到控制。它们应酌情符合产品规格文件、生产和上市许可卷宗或研究用药品卷宗的相关部分。从主文件复制工作文件时，不应在复制过程中引入任何错误或改动。

4.5.1. Documents should be regularly reviewed and kept up - to - date. Documents should be approved, signed, and dated by appropriate and authorised personnel. Documents should have unambiguous contents and be uniquely identifiable. The effective date should be defined.
4.5.1. 文件应定期审核并保持最新。文件应由适当且经授权的人员批准、签署和注明日期。文件应清晰明确、内容无歧义且具有唯一性。应定义生效日期。

4.5.2. Documents containing instructions should be laid out in an orderly fashion and be easy to review. The style and language of documents should fit with their intended use. Standard operating procedures, work instructions and methods should be written in an appropriate mandatory style by using pre - defined format. Data entry formats for completion of documents should be clearly defined. Written instructions may be supported with pictures, photos or videos. The documents containing the instructions should be easily accessible at the place where the described activities are carried out.
4.5.2. 包含规程的文件应有序编排，且易于查阅。文件的风格和语言应符合其预期用途。标准操作程序、工作说明和方法应采用标准格式编写。应使用预先定义的格式确定数据输入要求。应明确界定文件完成情况。书面说明可辅以图片、照片或视频。包含说明的文件应在进行所述活动的地点易于获取。

4.5.3. Instructions and procedures within the Quality Management System should be regularly reviewed and kept updated.
4.5.3. 质量管理体系内的规程和程序应定期审核并保持最新。

4.5.4. The issuance, revision, superseding and withdrawal of all documents should be controlled with maintenance of revision histories.
4.5.4. 所有文件的发布、修订、替代和撤回均应受到控制，并保留修订历史记录。

4.5.5. Where documents require the manual entry of data, sufficient space should be provided for such entries to ensure adequately clear and legible manual recording.
4.5.5. 对于需要手动输入数据的文件，应提供足够的空间，以确保输入清晰、合法且手动记录。

 

GOOD DOCUMENTATION PRACTICE
良好文件记录规范

4.56. Good Documentation practices are key to ensuring data integrity, and a fundamental part of a well - designed pharmaceutical quality system.
4.56. 良好的记录规范是确保数据完整性的关键，也是精心设计的药品质量体系的基本组成部分。

4.57. Procedures defining good documentation practices and arrangements for document control should be available within the pharmaceutical quality system. Good documentation practices should be implemented and enforced to ensure data integrity.
4.57. 在药品质量体系中，应具备定义良好记录规范和文件控制安排的程序。良好记录规范应得到实施和执行，以确保数据完整性。

4.58. Data entries should be accurate, and made in clear, legible, indelible way. Recorded media should be durable throughout the retention period. If this is not feasible, then true copies should be generated. For this a documented system should be in place to verify and record the integrity of a copy.
4.58. 数据录入应准确，并以清晰、易读、不可擦除的方式进行。记录介质在整个保存期内应耐用。如果这不可行，则应生成真实副本。为此，应建立一个有文件记录的系统，以验证和记录副本的完整性。

4.59. Records should be made or completed at the time each action is taken and in such a way that all GMP activities are traceable. It should be possible to identify the individual or the system that performed the task and when the task was performed.
4.59. 记录应在每次采取行动时进行或完成，并且方式应使所有GMP 活动都可追溯。应能够识别执行任务的个人或系统以及任务执行的时间。

4.60. Any alteration made to the entry on a document should be signed by the individual who made the change and dated; the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded.
4.60. 对文件录入内容的任何更改应由进行更改的个人签字并注明日期；更改应允许读取原始信息。在适当情况下，应记录更改的原因。

4.61. Records need to be a truthful and consistent representation of facts to ensure the accuracy of information, including data that is used to make critical decisions about the quality of products.
4.61. 记录需要真实且一致地反映事实，以确保信息的准确性，包括用于对产品质量做出关键决策的数据。

4.62. Specific controls should be implemented to ensure the integrity of raw data and results recorded on paper. These may include, but are not limited to:
4.62. 应实施特定控制措施，以确保纸质记录的原始数据和结果的完整性。这些措施可能包括但不限于：

i. control over the issuance and use of loose paper sheets (blank forms) at the time of recording data.
i. 在记录数据时，对散页纸（空白表格）的发放和使用进行控制。

ii. control over the issuance and bound, paginated notebooks.
ii. 对装订成册、编有页码的笔记本的发放进行控制。

iii. control over the identification and reconciliation of sequentially numbered copies of  blank forms with authenticity controls.
iii. 对带有真实性控制的按顺序编号的空白表格副本的识别和核对进行控制。

iv. Control that raw data is contemporaneously and accurately recorded by permanent means.

iv. 控制原始数据通过永久性方式及时且准确地记录。

4.63. Basic data integrity principles (table 1) applicable to both paper and electronic systems (i.e. ALCOA ++).

4.63. 适用于纸质和电子系统的基本数据完整性原则（表1）（即ALCOA ++）。

Table 1: Data integrity principles
表1：数据完整性原则

 

 

SIGNATURES IN GMP RELEVANT DOCUMENTATIONGMP相关文件中的签名

4.64. Signatures are essential for ensuring accountability for activities in a GMP environment at the time points the signatures are executed.
4.64. 在GMP环境中，签名对于在签名执行时确保活动可追溯、明确责任至关重要。

4.65. A signature represents the legally - binding will of the signatory. The signatory should sign with date and time. If signatures by initials are in use a procedure defining abbreviated signatures should be in place.
4.65. 签名代表签署人的具有法律约束力的意愿。签署人应注明签署日期和时间进行签名。若使用首字母缩写签名，应制定一份界定缩写签名规则的程序文件。

4.66 The identification of the signatory should be possible. Data or documents which are associated with the signature should be clearly identified. The meaning of the signa- ture (such as review, approve, responsibility, or authority) associated with the sig- nature should be clear.4.66 应能够识别签名人身份。与签名相关联的数据或文件应清晰识别。与签名相关联的签名含义（如审核、批准、负责、授权）应清晰明确。
4.67 The regulated user should establish a signature policy to ensure the adequate applica- tion of signatures. Personal authorised to sign should be clearly identified by name and bound by a name or the signature policy.4.67 受监管用户应制定签名政策，以确保签名的恰当应用。获授权签名的人员应通过姓名清晰识别，并受姓名或签名政策约束。
4.68 The regulated user should have identified those records which require a legally bind- ing signature.4.68 受监管用户应识别出那些需要具有法律约束力签名的记录。
4.69 Signatures should be indelible and traceable on the paper and the signed docu- ment of record, if a signature is transcribed to a signature electronically.4.69 若签名被转录为电子签名，在纸质文件以及已签署的记录文件上，签名应不可磨灭且可追溯。
4.70 If records exist only electronically, such records should be signed electronically. The use of electronic signatures should comply with the requirements of relevant laws and regulations (e.g. with hybrid system the electronic relevant signature should be distinctly categorised).4.70 若记录仅以电子形式存在，此类记录应进行电子签名。电子签名的使用应符合相关法律法规要求（如在混合系统中，相关电子签名应明确分类）。
4.71 The signatory should be qualified and authorised to perform the relevant tasks or re- views.4.71 签名人应具备资质并获授权，以执行相关任务或审核。
4.72 The regulated user should define the signatory’s role and responsibility in the signa- ture process.4.72 受监管用户应界定签名人在签名流程中的角色和职责。
4.73 The regulated user should ensure that the signatory’s role and qualification is con- sistent with the intent (content) of a signature.4.73 受监管用户应确保签名人的角色和资质与签名的意图（内容）相符。
4.74 To ensure the integrity of signatures during the whole life cycle of data the regulated user should establish the management and control of signatures as an element of data governance system.4.74 为确保数据整个生命周期中签名的完整性，受监管用户应将签名的管理和控制作为数据治理体系的一个要素来建立。
4.75 The data or documents which the signature is relevant for should fulfill the ALCOA++ principles.4.75 签名所关联的数据或文件应符合ALCOA++ 原则 。
 

RETENTION OF DOCUMENTS文件留存
4.76  It should be clearly defined which record is related to each activity and where this record is located, regardless of the technology, hybrid solution or service used. Risk - based control methods should be in place to ensure the integrity of the record through - out the lifecycle. The control measures should be covered by the validation scope. In case of electronic recording such measures should include back - up, restore and ar - chiving procedures as well as physical and logical controls. If the regulated user relies on hosted services, it is the responsibility of the regulated user to understand, approve and justify the control measures of a hosted service provider based on a service level agreement. Records should be available for review at any time applicable per the required retention period, accessible in a human readable format at any time applicable per the required.4.76 无论使用何种技术、混合解决方案或服务，都应明确界定每项活动对应的记录是什么，以及该记录的存放位置。应实施基于风险的控制方法，以确保记录在整个生命周期内的完整性。这些控制措施应纳入验证范围。对于电子记录，此类措施应包括备份、恢复和归档程序，以及物理和逻辑控制。如果受监管用户依赖托管服务，受监管用户有责任了解、批准并基于服务级别协议，对托管服务提供商的控制措施进行合理性论证。在规定的留存期内，记录应随时可供查阅，且应以人类可读的形式提供给所有相关人员。
4.77 Specific requirements apply to batch documentation which must be kept for one year after expiry of the batch to which it relates or at least five - years after certification of the batch by the Qualified Person, whichever is the longer. For investigational medicinal products, the batch documentation must be kept for at least five years after completion of formal discontinuation of the last clinical trial in which the batch was used. In relation to specifications for radiopharmaceuticals (e.g. Advanced Therapy Medicinal Products and products derived from human blood or human plasma) and specify that longer retention periods be applied to certain documents.4.77特定要求适用于批次文件，这些文件必须在其相关批次过期后保存一年，或者在合格人员对该批次进行认证后至少保存五年，以时间较长者为准。对于试验用药品，批次文件必须在使用该批次的最后一次临床试验完成或正式终止后至少保存五年。关于文件留存的其他要求，可能在与特定产品类型（如先进治疗医药产品以及源自人血或人血浆的产品）相关的法规中有所规定，并明确某些文件需适用更长的留存期限。
4.78. For other types of documentation, the retention period will depend on the business activity for which the documentation supports. Critical documentation, including raw data (for example relating to validation or stability), which supports information in the Marketing Authorisation should be retained whilst the authorization remains in force. It may be considered acceptable to retire certain documentation (e.g. raw data supporting validation reports or stability reports) where the data has been superseded by a full set of new data. Justification for this should be documented and should consider the requirements for retention of batch documentation; for example, in the case of process validation data, the accompanying raw data should be retained for a period at least as long as the records for all batches whose release has been supported on the basis of that validation exercise.4.78.对于其他类型的文件，留存期限将取决于文件所支持的业务活动。关键文件，包括原始数据（例如与验证或稳定性相关的数据），这些支持上市许可中信息的文件，应在许可有效期内留存。在数据已被一整套新数据取代的情况下，废弃某些文件（如支持验证报告或稳定性报告的原始数据）可能被视为可接受的做法。对此情况的合理性说明应形成文件记录，并且应考虑批次文件留存的要求；例如，对于工艺验证数据，相关的原始数据留存期限应至少与基于该验证活动获批放行的所有批次的记录留存期限一样长。
4.79. A documented process for the disposal of records should be in place to ensure that the correct original records or true copies are disposed of only after the defined retention period. Measures should be in place to reduce the risk of deleting the wrong documents. The access rights allowing disposal of records should be controlled.4.79. 应建立文件化的记录处置流程，以确保仅在规定的留存期限结束后，才对正确的原始记录或真实副本进行处置。应采取措施降低删除错误文件的风险。允许处置记录的访问权限应受到管控 。
 

DATA INTEGRITY IN DOCUMENTATION文件记录的数据完整性
4.80. The method of documentation should be integrated in the regulated user’s pharmaceu- tical quality system. Documents or records should be controlled in a risk - based ap- proach regardless of whether located in - house or in the form of hosted services. The regulated user should apply the principles of data integrity, data criticality and data risk within a data governance system and should consider the complete lifecycle of data. The data governance system should be an element of the pharmaceutical quality system. The ownership of data and the responsibility for data integrity should be de- fined.4.80. 文件记录方法应融入受监管用户的药品质量体系。无论文件或记录是内部留存还是以托管服务形式存在，都应采用基于风险的方法进行管控。受监管用户应在数据治理体系内应用数据完整性、数据关键性和数据风险原则，且应考虑数据的完整生命周期。数据治理体系应成为药品质量体系的一个要素。应明确数据的所有权以及数据完整性的责任 。
4.81. Risk - based control measures should be commensurate with the type and the complex- ity of a system. The pharmaceutical quality system should interface with independent review practices to detect risks to data integrity. Risks from human factors should be considered for effectively ensuring data integrity. Risk - reducing measures such as sec- ond person oversight, verification and checks should be implemented where appropri- ate and in the appropriate time to ensure critical process and testing steps are accu- rately and contemporaneously recorded.4.81. 基于风险的控制措施应与系统的类型和复杂程度相匹配。药品质量体系应与独立审核实践相衔接，以发现数据完整性方面的风险。为有效确保数据完整性，应考虑人为因素带来的风险。在适当情况下和适当时间，应实施诸如双人监督、核查与检查等降低风险的措施，以确保关键工艺和测试步骤被准确且同步地记录 。
 

HYBRID SYSTEMS混合系统
4.82. They should be clearly defined and identified, and each contributing element of the system validated and controlled according to risk management principles.4.82. 应对混合系统进行清晰界定和识别，且系统的每个构成要素都应根据风险管理原则进行验证和控制 。
4.83. A detailed description of the entire system should be available. The description should outline all major components, their functions, and interactions with each other as well as control for data management and data integrity. Procedures and records should be available to manage and appropriately control the interface between manual and com- puterised systems.4.83. 应备有对整个系统的详细描述。该描述应概述所有主要组件、其功能、组件之间的相互作用，以及数据管理和数据完整性的控制情况。应备有程序和记录，以管理并妥善控制手动系统与计算机化系统之间的接口 。
4.84. Appropriate quality risk management principles should be followed when assessing, defining, and demonstrating the effectiveness of control measures applied to the sys- tem.4.84. 在评估、界定和证明应用于该系统的控制措施的有效性时，应遵循适当的质量风险管理原则 。
4.85 Procedures should be in place to manage the review of data generated by hybrid systems which clearly outline the process for the evaluation, approval and archiving of electronic and paper-based data.4.85 应制定程序来管理对混合系统生成的数据的审查，这些程序应明确概述电子数据和纸质数据的评估、批准及存档流程。
 

GLOSSARY术语
ALCOA++
An acronym for “attributable, legible, contemporaneous, original and accu- rate”, which puts additional emphasis on the attributes complete, consistent, enduring, available and traceable – implicit basic ALCOA principles.ALCOA++是“可追溯（Attributable）、清晰可读（Legible）、同步性（Contemporaneous）、原始性（Original）、准确性（Accurate）” 的首字母缩写，额外强调了完整性（Complete）、一致性（Consistent）、持久性（Enduring）、可用性（Available）、可追溯性（Traceable）这些属性，而这些是基本ALCOA 原则中隐含的内容。
Archiving归档
Long term, or permanent retention of completed documentation and relevant metadata in its final form for the purposes of reconstruction of a process or activity.
对已完成的文件以及相关（内容，原文此处可能未完整显示，按现有翻译）进行长期或永久性留存
Automated scriptA 自动化脚本
piece of code used to automate repetitive processes一段用于自动执行重复流程的代码
Data数据
The contents of the record. Data may be defined as measurable or descriptive attribute of a physical entity, process, or event.记录的内容。数据可被定义为物理实体、流程或事件的可测量或描述性属性。
Data governance数据治理
The total sum of arrangements to ensure that data, irrespective of the format in which it is generated, recorded, processed, retained and used, will be attribut- able, legible, contemporaneous, original, accurate, complete, consistent, en- during, and available throughout the data lifecycle.为确保数据（无论其生成、记录、处理、留存和使用的格式如何）在整个数据生命周期内都具备可追溯性、清晰可读性、同步性、原始性、准确性、完整性、一致性、持久性和可用性，所采取的一系列安排的总和。
Data integrity数据完整性
Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, con- temporaneously recorded, original or a true copy, accurate and traceable (AL- COA++).数据完整性指数据的完整性、一致性和准确性。完整、一致且准确的数据应具备可追溯性、清晰可读性、同步记录性、原始性或为真实副本、准确性和可追溯性（即ALCOA++ 原则 ） 。
Data lifecycle数据生命周期
All processes related to the creating, recording, processing, reviewing, changing, deleting, reporting, transferring, storing, migrating, archiving, retrieving, and analyzing of data.与数据的创建、记录、处理、审核、变更、分析、报告、传输、存储、迁移、归档、检索和删除相关的所有流程。
Data management数据管理
The set of all methodological, conceptual, organisational and technical measures and procedures for handling data with the aim of incorporating it into business processes.为将数据纳入业务流程，处理数据时所采用的所有方法学、概念性、组织性以及技术性措施和程序的集合。
Data risk数据风险
The combination of the probability of occurrence of harm and the severity of that harm related to data (incompleteness, alterations or loss which compro - mise the integrity of data).与数据相关的危害发生概率和危害严重程度的组合（数据不完整、被篡改或丢失，从而损害数据完整性）。
Data criticality数据关键性
The degree of influence that data have on product safety as well as the regulatory compliance of processes, decisions and product quality.数据对产品安全性以及法规合规流程、决策和产品质量的影响程度。
Data Risk Management数据风险管理
An activity to be applied throughout the lifecycle of data considering the need to ensure data integrity. Risk management consists of risk identification, risk assessment, risk mitigation (e.g. risk acceptance, risk control, Risk management should link to relevant processes for data, configuration, and change management, man - agement procedures (e.g. business rules, etc.).一项需在数据的整个生命周期中开展的活动，需考虑确保数据完整性的需求。风险管理包括风险识别、风险评估、风险缓解和风险控制。风险管理应考虑其他相关程序（如配置与变更管理、数据管理流程、业务风险等）。
Data Risk Assessment 数据风险评估 
The process of evaluating the risks associated with the regulated user's data. It ensures an efficient and effective approach to data integrity by considering the vulnerability of data to involuntary or deliberate alteration resulting in risk - based control measures.评估与受监管用户数据相关风险的过程。通过考量数据因无意或蓄意篡改而面临的脆弱性，以确保采用高效且有效的方法保障数据完整性，进而制定基于风险的控制措施。
Data ownership数据所有权
The allocation of responsibilities for control of data to a specific process owner. Companies should implement systems to ensure that responsibilities for systems and their data are appropriately allocated and responsibilities understood.将数据控制的职责分配给特定的流程所有者。公司应实施相关系统，以确保系统及其数据的职责得到恰当分配，且职责被清晰理解。
Data quality数据质量
The degree to which a set of inherent characteristics (quality dimensions) of data fulfill requirements.Data should be fit for use in their intended operational, decision - making, and other roles and should exhibit conformance to regulatory standards that have been set, so that fitness for use is achieved.数据的一组固有特性（质量维度）满足要求的程度。数据应适用于其预定的操作、决策制定及其他用途，并且应符合已设定的监管标准，从而实现适用性。
Document文件
A formatted compilation of data. Operations and activities that are memorialized in (electronic) records may consist of one or more documents that describe the activity in a moment of time.经过格式化的数据汇编。在（电子）记录中记录的操作和活动，可能由一个或多个描述某一时刻活动的文件组成。
Electronic record电子记录
Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.以数字形式呈现的文本、图形、数据、音频、图片或其他信息表示的任意组合，由计算机系统创建、修改、维护、归档、检索或分发。
Hybrid system混合系统
A combination of paper - based and electronic means.基于纸质和电子方式的组合。
Homogenous systems同类系统
A system that is either paper or electronically based on - premises or a cloud service.一种要么基于纸质，要么基于本地电子方式，要么基于云服务的系统。
Meta data元数据
Describe the attributes of data and provides context and meaning. Metadata is any information used for the identification, description, and relationships of electronic records or their elements. Metadata gives data meaning, provides context, defines structure, and enables retrievability across systems, and usability, authenticity, and auditability across time.描述数据的属性并提供背景和含义。元数据是用于识别、描述电子记录或其元素及其相互关系的任何信息。元数据赋予数据意义、提供背景、定义结构，使数据能在系统间检索，并确保其在不同时间的可用性、真实性和可审计性。
Raw Data原始数据
Raw data is defined as the original record (data) which can be described as the first capture of stored information, whether recorded on paper or electronically.Information that is originally captured in a dynamic state should remain available in that state.原始数据被定义为原始记录（数据），可描述为对存储信息的首次捕获，无论其是记录在纸质上还是以电子方式记录。最初以动态状态捕获的信息应在该状态下保持可用。
Record记录
Memorializes, or makes information permanent about, an action, activity and event that caused its creation.记录使关于引发其创建的行动、活动和事件的信息得以留存或永久保存。
Regulated user受监管用户
Marketing Authorisation Holder, Manufacturers, control laboratories, import - ers, and wholesale distributors (if the wholesale distributor holds a manufacturing license).上市许可持有人、制造商、控制实验室、进口商和批发分销商（若批发分销商持有生产许可证）。
Risk based approach for data integrity基于风险的数据完整性方法
A process to define critical data, documents and the actions used to monitor activities like capturing, derivation, migration, storage, communication and archiving to ensure that data and documents remain in a state of control throughout the entire lifecycle and to maintain its integrity.一种用于界定关键数据、文件以及用于监控诸如捕获、推导、迁移、存储、传输和归档等活动的行动的流程，以确保数据和文件在整个生命周期内都处于受控状态，并维持其完整性。
Specification质量标准
A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. “Conformance to specification” means that the material, when tested according to the listed analytical procedures, will meet the listed acceptance criteria.一份包含测试项目、分析方法引用以及适用接受标准（为所述测试设定的数值限度、范围或其他标准）的清单。它确立了物料为实现预期用途应符合的一系列标准。“符合质量标准” 指当按照所列分析方法对物料进行测试时，物料会满足所列接受标准 。
True copy真实副本
An exact copy of original documentation that preserves the same content, meaning and attributes of the original. The term “true copy” is synonymous with “certified” or “verified copy”.原始文件的精确副本，保留与原始文件相同的内容、含义和属性。“真实副本” 一词与“经认证副本” 或“经核实副本” 同义 。
Type of service服务类型
On - premises IT service or outsourced hosted (cloud) IT service本地信息技术服务或外包托管（云）信息技术服务
Verified copy经核实副本
Refers to definition of true copy指“真实副本” 的定义（即与“真实副本” 定义一致 ，说明其遵循真实副本的界定 ）
Data Risk Assessment数据风险评估
The process of evaluating the risks associated with the regulated user’s data.评估与受监管用户数据相关风险的过程。

 

来源：未知

关键词： 新版EUGMP 文件记录 附录 计算机化系统