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ASTM
E2500-07 Standard Guide for Specification, Design, and Verification of
Pharmaceutical and Biopharmaceutical Manufacturing Systems and
Equipment
This standard is issued under the fixed designation E 2500; the number
immediately following the designation indicates the year of original
adoption or, in the case of revision. A number in parentheses indicates
the year of last re-approval. A superscript epsilon (ε)
indicates an editorial change since the last revision or re-approval.
制
药、生物制药生产系统和设备的规范、设计、验证标准指南
这个标准出版的固定名称是E2500;名称后紧接的数字表示最初版本的年份，或修订的情况。括号中的数字表示最近一次重新批准的年份。上标(&
amp;
amp;
amp;
epsilon;)表示自从最近一次修订或重新批准以来，编辑修改情况。
1.
Scope范围
1.1 This guide is applicable to all elements of pharmaceutical and
biopharmaceutical manufacturing systems including: facility equipment,
supporting utilities, associated process monitoring and control
systems, and automation systems that have the potential to affect
product quality and patient safety.
1.1本指南适用于制药和生物制药生产系统中，可能影响产品质量和病人安全的所有要素，其中包括：设施设备，公用支持系统，相关过程的监控和控制系统，自
动化系统。
1.2 For brevity, these are referred to throughout the rest of thin
guide as manufacturing systems.
1.3 This guide may also be applied to laboratory, information, and
medical device manufacturing systems.
1.4 This guide is applicable to both new and existing manufacturing
systems. The approach may be used for the implementation of changes to
existing systems, and their continuous improvement during operation.
1.5 This guide is applicable throughout the life-cycle of the
manufacturing system from concept to retirement.
1.2简要的说，这是一个全国通用的有关生产系统的小指南。
1.3本指南也可以适用于实验室，信息和医疗设备制造系统。
1.4本指南适用于新的和现有的生产系统。该方法可用于实行对现有系统的变更，并实现运行过程中，对现有系统的持续改进。
1.5本指南适用于生产系统从概念到报废的整个生命周期。
1.6 This standard does not address employee health and safety,
environmental, or other non-GXP regulations. This standard does not
purport to address all of the safety concerns, if any, associated with
its use. It is the responsibility of the user of this standard to
establish appropriate safety and health practices and determine the
applicability of regulatory limitations prior to use.
1.6该标准不涉及讨论雇员的健康和安全，环境，或其他非GXP的规定。这一标准不是讨论所有的安全问题，如果有的话，与其使用相关。本标准的使用者的职
责，是建立适当的安全和卫生标准，并在使用前确定限制性规范的适用性。
2. Reference Documents
参考文献
2.1 ASTM Standards: 2
E 2363 Terminology Relating to Process Analytical Technology in the
Pharmaceutical Industry
2.2 Other Publications:
ICH Q8 Pharmaceutical Development Handbook3
ICH Q9 quality Risk Handbook3
Pharmaceutical cGMPs for the 21st Century—A Risk-Based
Approach4
2.1美国试验与材料协会标准（简称：ASTM标准）
E 2363制药工业过程分析技术的有关术语
2.2其它出版物
ICH Q8 药品研发手册
ICH Q9 质量风险管理手册
21世纪药品CGMP—基于风险管理方法
3. Terminology
术语
3.1 Definitions—For definitions of terms used in this guide,
refer to Terminology E 2363.
定义--这个指南中使用的术语的定义，请参阅E2363术语部分。
3.1.1acceptance criteria—the criteria that a system or
component must satisfy in order to be accepted by a user or other
authorized entity.
验收标准－－这个标准必须确保某一系统或组件能够被使用者或其他授权机构所接受。
3.1.2design reviews—planned and systematic reviews of
specifications, design, and design development and continuous
improvement changes performed as appropriate throughout the life-cycle
of the manufacturing system. Design reviews evaluate deliverables
against standards and requirements, identify problems, and propose
required corrective actions.
设计回顾――在整个生产系统的生命周期中，有计划、系统地对规范、设计、设计开发和持续改进情况进行适当的回顾审查。设计回顾可根据标准和要求，交付评
价，找出问题，并提出必要的纠正措施。
3.1.3manufacturing systems—elements of pharmaceutical and
biopharmaceutical manufacturing capability, including manufacturing
systems, facility equipment, process equipment, supporting utilities,
associated process monitoring and control systems, and automation
systems, that have the potential to affect product quality and patient
safety.
生产系统---制药和生物制药生产能力的各要素，包括生产系统，设施设备，工艺设备，公共支持系统，相关的过程监测和控制系统，自动化系统，所有这些，都
有可能影响产品质量和病人安全。
3.1.4 subject matter experts (SMEs)—individuals with specific
expertise and responsibility in a particular area or field (for
example, quality unit, engineering, automation, development,
operations, and so forth).
相关领域的专家（SMEs）----在某一特定领域或方面（例如，质量部门，工程学，自动化技术，研发，经营，等等），个人拥有的资格和特殊技能。
3.1.5 verification—a systematic approach to verify that
manufacturing systems, acting singly or in combination, are fit for
intended use, have been properly installed, and are operating
correctly. This is an umbrella term that encompasses all types of
approaches to assuring systems are fit for use such as qualification,
commissioning and qualification, validation, system validation or other.
验证---是一个系统的方法，用来证实生产系统、单独或联合操作，是否符合其预定用途，是否已正确安装，并正确运行。这是一个总称，它包括所有确保系统适
合其用途的方法，如确认，调试和确认，验证，系统验证或其他。
1 This guide under the jurisdiction of ASTM Committee E55 on
Manufacture of Pharmaceutical Products and is the direct responsibility
of Subcommittee E55.03 on General Pharmaceutical Standards.
Current edition approved June 1,2007. Published August 2007.
本指南由ASTM委员会E55（医药产品的生产）管辖, 具体由E55.03（一般的药品标准）小组委员会直接负责。
当前版本2007年6月1日批准。2007年8月出版。
2 For referenced ASTM standards, visit the ASTM website, www. astm.
org, or contact ASTM Customer Service at service@astm.org. for Annual
Book of ASTM Standards volume information, refer to the
standard’s Document Summary page on the ASTM website.
有关ASTM标准，请访问ASTM的网站，www.astm.org. 或联系ASTM客户服务网站service@astm.org .
ASTM标准的年刊信息，请参阅ASTM网站上本标准的文件摘要页。
3 Available from International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use(ICH),ICH
secretariat, c/o IFPMA,15ch. Louis-Dunant, P.O. Box 195,1211 Geneva
20,Switzerland, http://www.ich.org.
可联系人用药品注册技术要求国际协调会(ICH), 转ICH秘书处，IEPMA,15号。
邮政信箱Louis-Dunant 195,1211 Geneva
20，Switzerland、http://www.ich.org。
4 Available from Food and Drug Administration(FDA),5600 Fishers Ln.,
Rockville, MD 20857, http://www.fda.gov.
可联系美国食品药品管理局(FDA), Fishers Ln., Rockville, MD 20857, http://www.fda.gov.
4. Summary of Guide
4.指南概述
4.1 This guide describes a risk-based and science-based approach to the
specification, design, and verification of manufacturing systems and
equipment that have the potential to affect product quality and patient
safety.
本指南以风险和科学为基础的方法，对潜在可能影响产品质量和病人安全的生产系统和设备的规范，设计和验证进行描述。
4.2 This guide describes a systematic, efficient, and effective way of
ensuring that manufacturing systems and equipment are fit for intended
use, and that risk to product quality, and consequently to patient
safety, are effectively managed to the extent that these are affected
by such systems and equipment.
本指南描述了一个系统的、高效的和有效的方式，确保生产系统和设备符合预期的使用目的，而且对关乎产品质量和随后病人安全的风限进行有效管理，受系统和设
备影响的风险都在范围内。
4.3 The overall objective is to provide manufacturing capability to
support defined and controlled processes that can consistently produce
product meeting defined quality requirements.
总的目标是提供生产能力，以支持明确的、受控的工艺能够持续生产出符合质量规范的产品。
4.4 The approach described within this guide also supports continuous
process capability improvements and enables innovation such as the
implementation of Process Analytical Technology (PAT).
在本指南内描述的方法还支持生产工艺能力的持续改进，实现创新，如运用过程分析技术（PAT）
4.5 The main elements of this guide are:
4.5.1 The underlying key concepts that should be applied,
4.5.2 A description of the specification, design, and verification
process, and
4.5.3 A description of the required supporting processes.
4.5本指南的主要要素是：
4.5.1以下根本的关键概念必须应用，
4.5.2一个对规范，设计和验证过程的描述
4.5.3一个对必需的辅助性工艺的描述
5. Significance and Use意义和用途
5.1 Application of the approach described within this guide is intended
to satisfy international regulatory expectations insuring that
manufacturing systems and equipment are fit for intended use, and to
satisfy requirements for design, installation, operation, and
performance.
5.2 The approach described in this guide applies concepts and
principles introduced in the FDA initiative, Pharmaceutical cGMPs for
the 21st Century—A Risk-Based Approach.
5.3 This guide may be used independently or in conjunction with other
proposed E55 standards to be published by ASTM International.
5.1这个指南中所描述的方法的应用，目的是为了满足国际规范所期望的那样：使生产系统和设备符合预期的用途，满足设计，安装，运行及性能的要求。
5.2本指南中描述的方法所运用的概念和原理，在FDA发起的，21世纪药品生产cGMPs-一个基于风险分析的方法中有介绍。
5.3本指南可单独使用或与ASTM国际部出版的E55号标准联合使用。
6. Key Concepts重要概念
6.1 This guide applies the following key concepts:
Risk-based Approach
Science-based
Approach
Critical Aspects of
Manufacturing Systems
Quality by Design
Good Engineering
Practice
Subject Matter Expert
Use of Vendor
Documentation
Continuous Process
Improvement
6.1本指南使用以下重要概念：
基于风险的方法
基于科学的方法
生产系统的关键方面
质量源于设计
良好的工程实践
专门领域的专家
供应商文件的使用
工艺持续改进
6.2 Risk-based Approach:
6.2.1 Risk management should underpin the specification, design, and
verification process, and be applied appropriately at each stage. 6.2.2
Two primary principles of quality risk management are identified in ICH
Q9:
6.2.2.1 The evaluation of the risk to quality should be based on
scientific knowledge and ultimately link to the protection of the
patient.
6.2.2.2 The level of effort, formality and documentation of the quality
risk management process should be commensurate with the level of risk.
6.2.3 These principles should be applied to specification，design, and
verification of manufacturing systems.
6.2.4 The scope and extent of quality risk management for
specification, design, and verification activities and documentation
should be based on the risk to product quality and patient safety.
6.2基于风险的方法
6.2.1风险管理应该支持规范，设计和验证过程，并在每一阶段适当应用。
6.2.2在ICH Q9中明确了质量风险管理的两个基本原则：
6.2.2.1质量风险评价必须以科学知识为基础，并最终与保护病人安全相联系。
6.2.2.2质量风险管理实施的力度、形式和文件必须与风险级别（程度）相匹配。
6.2.3这些原理必须应用于生产系统的规范，设计和验证。
6.2.4与规范、设计、验证有关的质量风险管理和文件系统的广度和深度，都必须以产品质量风险和病人安全为基础。
6.3 Science-based Approach:
6.3.1 Product and process information, as it relates to product quality
and patient safety, should be used as the basis for making science-and
risk-based decisions that ensure that the manufacturing systems are
designed and verified to be fit for their intended use.
6.3.2 Examples of product and process information to consider include:
critical quality attributes (CQAs), critical process parameters (CPPs),
process control strategy information, and prior production experience.
6.3基于科学的方法
6.3.1产品和工艺的信息，如果与产品质量和病人安全有关，都必须作为科学－风险决策的基础，确保生产系统设计和验证至符合其预定用途。
6.3.2例如，应考虑的产品和工艺信息的包括：关键质量属性（ CQAs ），关键工艺参数（CPPs），过程控制策略信息，和以往的生产经验。
6.4 Critical Aspects of Manufacturing Systems:
6.4.1 Critical aspects of manufacturing systems are typically
functions, features, abilities, and performance or characteristics
necessary for the manufacturing process and systems to ensure
consistent product quality and patient safety. They should be
identified and documented based on scientific product and process
understanding.
6.4.2 For brevity these are referred to throughout the rest of this
guide as critical aspects.
6.4.3 Verification activities should focus on these aspects of
manufacturing systems and should be documented. The verification
process is defined in 7.4.
6.4生产系统的关键方面：
6.4.1生产系统的关键方面通常是功能，特征，性能，和持续保持产品质量和病人安全所必须的生产工艺和系统的性能或特征。他们应该在科学的产品和工艺的
理解基础上进行确定并记录。
6.4.2简而言之，作为关键方面，可参阅本指南的其余部分。
6.4.3验证事务应侧重于生产系统的这些方面，并应记录在案。工艺验证参见7.4。
6.5 Quality by Design:
质量源于设计
6.5.1 Quality by design concepts should applied to ensure that critical
aspects are designed into systems during the specification and design
process. The critical aspects of the design and associated acceptance
criteria should be documented.
在规范和工艺设计过程中，必须应用质量源于设计的概念，确保关键方面都设计入系统中。设计的关键方面和相关验收标准应记录在案。
6.5.2 Assurance that manufacturing systems are fit for intended use
should not rely solely upon verification after installation, but be
achieved by a planned and structured verification approach applied
throughout the system life cycle.
确保生产系统符合其预期的用途，不能仅仅依赖于安装后的验证，而是应做到将有计划，有组织的验证方法应用于系统的整个生命周期。
6.6 Good Engineering Practice: 良好的工程实践：
6.6.1 Good Engineering Practice (GEP) should underpin and support the
specification, design, and verification activities.
良好的工程实践（GEP）应当巩固和支持规范，设计和验证活动
6.6.2 Good Engineering Practice is defined as those established
engineering methods and standards that are applied throughout the life
cycle to deliver appropriate and effective solutions.
良好的工程实践定义为，那些为得到适当和有效的解决办法，而建立工程方法和应用于整个生命周期的标准。
6.6.3 Examples of Good Engineering Practices include:
6.6.3良好的工程实践例子包括：
6.6.3.1 Specification, design, and installation activities should take
full account of all applicable requirements, including GXP, safety,
health, environmental, ergonomic, operational, maintenance, recognized
industry standards, and other statutory requirements.
6.6.3.1规范，设计和安装活动应充分考虑到所有适用的要求，包括GXP，安全，卫生，环境，人类工程学，操作，维护，公认的行业标准，和其他法定要
求.
6.6.3.2 Adequate provisions related to quality should be included in
specification, design, procurement, and other contractual documents.
6.6.3.2在规范，设计，采购，和其他合同文件中应包括有足够的与质量有关的条款。
6.6.3.3 Life-cycle documentation covering planning, specification,
design, verification, installation, acceptance, and maintenance should
be produced.
6.6.3.3必须制定涵盖计划，规范，设计，验证，安装，验收，维保等整个生命周期的文件。
6.6.3.4 An appropriate degree of oversight and control should be
achieved by suitable verification of execution, construction and
installation activities.
6.6.3.4对实施验证，施工和安装等活动进行合适的确认，达到适当程度的监督和控制。
6.7 Subject Matter Experts:
6.7相关领域的专家：
6.7.1 Subject matter experts are defined as those individuals with
specific expertise and responsibility in a particular area or field
(for example, quality unit, engineering, automation, development,
operations and so forth).
6.7.1相关领域专家的定义是，那些在特定领域里有专业技能和资质的人（例如质量部门，工程，自动化技术，研发，生产等）。
6.7.2 Subject matter experts should take the lead role in the
verification of manufacturing systems as appropriate within their area
of expertise and responsibility.
6.7.2相关领域专家，在他们相应的专业技能和资格领域内，在生产体系验证中起带头作用。
6.7.3 Subject matter expert responsibilities include planning and
defining verification strategies, defining acceptance criteria,
selection of appropriate test methods, execution of verification tests,
and reviewing results.
6.7.3相关领域专家的职责，包括计划和制定验证策略，制定验收标准，选择适当的测试方法，实施验证测试并评价结果。
6.8 Use of Vendor Documentation:
6.8供应商文件的使用：
6.8.1 Vendor documentation, including test documents may be used as
part of the verification documentation, providing the regulated company
has assessed the vendor, and has evidence of:
6.8.1供应商文件（包括一些测试文件），都可用作验证文件的一部分，——只要供应商经负法律责任的公司评
价，并且证明：
6.8.1.1 An acceptable vendor quality system,
6.8.1.1有一个可接受的供应商质量体系
6.8.1.2 Vendor technical capability, and
6.8.1.2供应商具技术能力，并且
6.8.1.3 Vendor application of GEP such that information obtained from
the vendor will be accurate and suitable to meet the purpose of
verification.
6.8.1.3供应商应用GEP，因而从供应商获得的有关信息是准确的和合适的并符合验证目标。
6.8.2 If inadequacies are found in the vendor quality system, technical
capability, or application of GEP, then the regulated company may
choose to mitigate potential risks by applying specific, targeted,
additional verification checks or other controls rather than repeating
vendor activities and replicating vendor documentation.
6.8.2如果在供应商质量体系，技术能力或GEP应用中发现有不足之处，负法律责任的公司可通过应用特定的、有针对性的、额外的验证检查，或其它控制方
式来转移风险，而不是重复供应商的行为和复制供应商文件。
6.8.3 The decision and justification to use vendor documentation, to
support the verification of critical aspects of the manufacturing
element, should be based on the intended use of the manufacturing
system, and should be documented and approved by subject matter experts
including the quality unit.
6.8.3使用供应商文件来支持生产要素关键方面的验证的决定和判断，必须以生产系统的预期用途为基础，必须记录在案并经过相关专业领域专家（包括质量部
门）认可。
6.9 Continuous Improvement:
6.9持续改进
6.9.1 As experience is gained in commercial production, opportunities
for improvements should be sought bases on periodic review and
evaluation, operational and performance data, and root-cause analysis
of failures.
6.9.1当在商业化生产中积累一定的经验后，应在周期性的回顾评价、性能数据以及分析失败的根本原因的基础上，寻找机会改进工艺。
6.9.2 Change management should provide a dependable mechanism for
prompt implementation of technically sound improvements following the
approach to specification, design, and verification described in this
guide.
6.9.2变更管理应遵循本指南中所描述的规范，设计和验证方法，为迅速实施合理的技术改进，提供一个可靠的机制。
7. Process工艺
7.1 Overview—The process of specification, design, and
verification of manufacturing systems should include the following
activities:
概述-生产系统的规范，设计和验证过程应当包括下列活动：
Requirements definition 明确需求
Specification and design 规范和设计
Verification
验证
Acceptance and release 验收和放行
7.1.1 Good Engineering Practice should be applied throughout the
process.
7.1.1整个生产工艺都必须应用GEP。
7.1.2 Risk management should be performed as appropriate to evaluate
the risks to product quality and patient safety related to the
manufacturing system and corresponding design solution. Risk management
is a supporting process and is defined in 8.2.
风险管理应对生产系统中与产品质量和患者安全相关的风险进行适当的评估，并提出相应的设计方案。风险管理是一个辅助性工艺，在8.2中有对它的描述。
7.1.3 Design reviews should be performed as appropriate throughout the
life-cycle of the manufacturing system. The design review process is a
supporting process and is defined 8.3.
7.1.3适当的设计审核应贯穿整个生产系统的生命周期。设计审核是一个辅助性工艺，在8.3中有对它的描述。
7.1.4 Change management should be applied throughout the process. The
change management process is supporting process and is defined 8.4.
7.1.4整个过程还必须应用变更管理，变更管理是也是一个辅助性工艺，在8.4中有对它的描述。
7.2 Requirements Definition:
7.2.1 Specific requirements should be identified and should provide the
basis of further specification, design, and verification of the
manufacturing system.
7.2.2 These specific requirements relative to product quality and
patient safety should be based upon:
7.2.2.1 Product knowledge and understanding,
7.2.2.2 Process knowledge and understanding,
7.2.2.3 Regulatory requirements, and
7.2.2.4 Company quality requirements.
7.2.3 Product and process knowledge and understanding, including
knowledge of sources of variability in the product and process, the
identification of critical quality attributes, and scientific data
gathered during experimental and development work and manufacturing
experience. Product and process knowledge forms the basis of scientific
understanding as described in ICH Q8 and process control strategy.
7.2 明确需求：
7.2.1特殊需求必须明确，并应对生产系统更进一步的规范、设计和验证提供基础。
7.2.2这些与产品质量和病人的安全有关的特殊需求，应基于以下几点：
7.2.2.1产品知识和理解
7.2.2.2工艺知识和理解
7.2.2.3法规的要求
7.2.2.4公司的质量要求
7.2.3对产品和工艺的认识和理解，包括产品和工艺的知识来源的变异性，关键质量属性的识别，在实验、研发和生产实践过程中科学数据的收集。产品和工艺
知识形成科学理解和工艺控制策略的基础，正如ICH Q8中描述的一样。
产品认识
工艺认识
监管要求
法规要求
公司质量要求
FIG. 1 The Specification, Design, and Verification Process
图1：规范，设计和验证过程
7.3 Specification and Design:
7.3.1 Firms should develop appropriate mechanisms to communicate
requirement inputs, including product quality considerations, to those
responsible for design, so that the manufacturing system may be
properly designed based upon relevant knowledge of product, process,
and other requirements.
7.3.2 Specification and design activities should include a focus on
those aspects that have been identified as begin critical to product
quality and patient safety. These critical aspects of the manufacturing
system should be identified and documented by subject matter experts.
7.3 规范和设计
7.3.1公司必须制定适当的机制，将需求参数包括产品质量考虑与那些设计联系起来，以使生产系统在相关的产品、工艺知识和其它要求的基础上，进行适当的
设计。
7．3.2规范和设计活动，必须包括集中于那些已经明确的与产品质量和病人安全有关的关键方面。这些生产系统的关键方面必须是经过相关领域的专家确认的，
并归档。
7.4 Verification—A systematic approach should be defined to
verify that manufacturing systems, acting singly or in combination, are
fit for intended use, have been properly installed, and are operating
correctly. This verification approach should be defined and documented.
The extent of verification and the level of detail of documentation
should be based on risk, including those associated with product
quality and patient safety, and the complexity and novelty of the
manufacturing system.
7.4验证——–一个系统的方法，用来证实生产系统、单独或联合操作，适合预定用途，已正
确安装，并正确运行。这种验证方法必须明确并记录归档。验证的广度和文件的详细程度，必须以包括与产品质量和病人安全有关的风险，和生产系统的复杂性、重
要性为基础。
7.4.1 Acceptance Criteria:
7.4.1.1 Acceptance criteria are the criteria that a manufacturing
system must satisfy in order to be fit for intended use and to be
accepted by a user or other authorized entity.
7.4.1.2 Acceptance criteria should be defined by subject matter
experts.
7.4.1.3 Acceptance criteria of critical aspects (that is, critical to
product quality and patient safety) should be approved by the quality
unit.
7.4.2 Verification Strategy:
7.4.2.1 The acceptance criteria and verification strategy should be
documented in appropriate verification plans.
7.4.2.2 The verification plan should define what constitutes acceptable
documentation of subsequent verification activities.
7.4.2.3 The verification plan should be developed and approved by
subject matter experts. Verification plans for systems containing
critical aspects should be approved by the quality unit.
7.4.1验收标准
7．4.1.1验收标准就是，生产系统必须满足其预期用途，并被使用者或验收机构所接收的标准。
7.4.1.2验收标准必须由专门领域的专家进行确定。
7.4.1.3关键方面的验收标准（即与产品质量和病人安全有关的方面）必须由质量部门批准。
7.4.2验证策略
7.4.2.1验收标准和验证策略，必须以文件形式记入验证计划中。
7.4.2.2验证计划必须明确什么组成了随后的验证活动中可接受的文件。
7.4.2.3验证计划必须不断地改进，并由专门领域的专家批准。系统的验证计划还应包括由质量部门批准的关键方面。
7.4.3 Verification Activities:
7.4.3.1 Subject matter experts should perform or oversee verification
activities, and document verification results, as defined in the
verification plans.
7.4.3.2 Vendor verification documentation may be used, as described in
6.8.
7.4.3.3 The completion of verification activities should be documented.
7.4.3验证活动
7.4.3.1按验证计划所要求的那样，专门领域的专家必须执行或监督验证的实施，并记录验证结果。
7.4.3.2供应商验证文件也可能被使用，在6.8中有描述。
7.4.3.3验证完成后必须进行记录归档。
7.4.4 Verification Review:
7.4.4.1 All completed verification documentation should be reviewed by
suitably qualified and independent subject matter expert(s), who did
not execute the verification test.
7.4.4.2 The reviewers should ensure that all tests have been completed
and appropriately documented.
7.4.4.3 Departures and deviations from verification plans should be
addressed and resolved by the reviewer and/or other appropriate subject
matter expert(s).
7.4.4验证审核
7.4.4.1所有验证文件完成后，必须由有资格的、专门领域专家进行评价，这些专家必须是独立的、未参与到具体验证实验中的人。
7.4.4.2这些评价必须确保所有的实验都已完成并且记录。
7.4.4.3与验证计划有偏离和偏差时，由审核人和（或）相应领域的专家进行讨论和解决。
7.5 Acceptance and Release:
7.5.1 Subject matter experts should confirm that the manufacturing
system is fit for intended use. This confirmation should be documented.
7.5.2 Such documentation should include a review or overview of the
results, and a review of any non-conformance with stated acceptance
criteria of critical aspects.
7.5接受和放行
7.5.1专门领域的专家必须证实生产系统符合预期用途。这个证实必须以文件形式记录归档。
7.5.2这文件必须包括对结果的评价和概括，还包括对任何与已制定的关键方面验收标准不符合的评价。
7.5.3 The documentation should contain a clear statement as to whether
or not the manufacturing system is fit for intended use, based on this
review. The persons involved in making this determination should be
identified and documented.
7.5.4 Such documentation should be prepared and approved by subject
matter experts. Such documentation for systems with critical aspects
should be approved by the quality unit.
7.5.5 Following these approvals, the manufacturing system may be
released for operational use.
7.5.3这种文件必须根据评价情况，明确声明生产系统是否符合预期用途。参与决策的人应该经过确认并记录归档。
7.5.4这些文件应该由专门领域专家准备并批准。系统关键方面的文件应由质量部门批准。
7.5.5批准后，生产系统便可放行并投入使用。
8. Supporting Processes
8.辅助性工艺
8.1 The specification, design, and verification process described
should be supported by risk management, design review, and change
management, as described in the following subsections.
8.1规范、设计和工艺验证的描述，应该由下面描述的风险管理、设计评价和变更管理进行支持。
8.2 Quality Risk Management:
8.2质量风险管理：
8.2.1 Quality risk management is a systematic process for the
assessment, control, communication and review of risks to the quality
of the drug and the safety of the patient.
8.2.1质量风险管理是一个系统过程，它对与药品质量和病人安全有关的风险进行评估、控制、通报和回顾。
8.2.2 Risk assessments should be performed at appropriate stages to
evaluate the risks to product quality and patient safety related to the
manufacturing systems and corresponding design solutions.
8.2.2在生产系统中，在适当阶段必须对与产品质量和病人安全有关的风险进行评估，并具有相对应的设计方案。
8.2.3 The risks pertaining to delivery including vendor or construction
risk, and risks due to technological novelty or complexity should be
considered relative to their ultimate impact on product quality and
patient safety.
8.2.3应通报的风险，包括供应商或施工风险、有关技术的新颖性复杂性风险都必须考虑其是否最终影响产品质量和病人安全。
8.2.4 Risk assessments should be performed by appropriate subject
matter experts.
8.2.4风险评估应该由适当的专门领域的专家进行。
8.2.5 Based on risk assessments, appropriate controls and verification
techniques should be selected to manage risk to an acceptable level,
focusing on those relating to the critical aspects of the manufacturing
system.
8.2.5以风险评估为基础，选择适当的控制和验证技术，将风险管理进行至一个可接受水平。风险评估主要集中于那些生产系统的关键方面。
8.2.6 The level of control and verification should be commensurate with
the level of risk to product quality and patient safety.
8.2.6控制和验证水平必须与产品质量、病人安全的风险水平相匹配。
8.2.7 Where risks cannot be eliminated by design, other appropriate
risk control mechanisms should be applied.
8.2.7当风险不能通过设计来消除时，就应当启用适当的风险控制机制。
8.2.8 More details on risk management can be found in the ICH Q9.
8.2.8有关风险管理的更详细资料在ICH Q9可以找到。
8.3 Design Review:
8.3设计评审
8.3.1 Design reviews are planned and systematic reviews of
specifications, design, design development, and continuous improvement
changes performed as appropriate throughout the life-cycle of the
manufacturing system.
8.3.1设计评审――在整个生产系统的生命周期中，有计划、系统地对规范、设计、设计开发和持续改进情况进行适当的审查。
8.3.2 Design reviews evaluate deliverables against standards and
requirements, identify problems, and propose required corrective
actions.
8.3.2设计评审可根据标准和要求进行交付评价，找出问题，并提出必要的纠正措施。
8.3.3 Design reviews should be employed to ensure that:
8.3.3采用设计评审，以确保：
8.3.3.1 Product and process requirements are appropriately addressed.
8.3.3.1产品和工艺要求得到适当的讨论。
8.3.3.2 Critical aspects of manufacturing systems are appropriately
addressed.
8.3.3.2生产系统的关键方面得到适当的讨论。
8.3.3.3 Risks to product quality and patient safety have been
identified
8.3.3.3产品质量和病人安全有关的风险得到识别。
8.3.3.4 Unacceptable risks are mitigated by design or by other means.
8.3.3.4不可接受的风险被设计或其他方法所转移。
8.3.4 Design reviews should be performed by appropriate subject matter
experts.
8.3.4设计评审应该由适当的专门领域的专家进行。
8.3.5 Design reviews should be documented. The individuals performing
the review should be identified.
8.3.5设计评审必须记录归档。个人进行的评审必须明确。
8.3.6 Design reviews documentation should include a statement that the
item in question is acceptable, provided the proposed corrective
actions are completed
8.3.6设计评审文件必须包括一项声明：即这个被讨论的项目是可接受的，并提供已完成的纠正措施。
8.4 Change Management:
8.4变更管理
8.4.1 Change management processes should be established and be applied
throughout the life-cycle
8.4.1必须建立变更管理过程并将其应用于整个生命周期。
8.4.2 Before acceptance, Change management processes should be applied.
This process should be managed by, and changes approved by, subject
matter experts. Changes affecting critical aspects of manufacturing
systems should be communicated to the quality unit.
8.4.2在验收之前，变更管理过程必须被应用。该过程必须由相关领域的专家进行管理和并进行变更批准。影响生产系统关键方面的变更，应该及时报告质量部
门。
8.4.3 After acceptance, prior to manufacturing for commercial use,
operational change management should be applied. Under operational
change management, all changes related to specific requirements
relative to product quality and patient safety require prior approval
by the quality unit, unless predefined arrangements are established
covering specific types of changes or circumstances.
8.4.3在验收之后，商业化生产之前，应进行动态的变更管理。在动态的变化管理之下，所有与产品质量和病人安全有关的变更都必须预先得到质量部门的批
准，除非是预先安排的特定类型的变更或情况。
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