中国GMP附录-确认和验证-中英
附件1
Annex 1
确认与验证
Qualification and Validation
（征求意见稿）
(Draft for Comments)
第一章范围
Chapter One Scope
第一条本附录适用于《药品生产质量管理规范》中涉及的所有确认与验证活动。Article 1 This appendix applies to all qualification and validation activities involved in Good Manufacturing Practice.
第二章原则
Chapter Two Principles
第二条企业应当确定需要进行的确认或验证工作，以证明有关操作的关键要素能够得到有效控制。确认和验证的范围和程度应根据风险评估的结果确认。确认与验证应当贯穿于产品生命周期的全过程。
Article 2 A manufacturer should determine the required qualification or validation activities to prove that the critical aspects of relevant operations can be effectively controlled. The scope and extent of qualification and validation should be determined based on risk assessment results. Qualification and validation activities should be throughout the entire life cycle of a product.
第三章验证计划
Chapter Three Validation Plan
第三条所有的确认与验证活动都应当事先计划。确认与验证的关键要素都应在验证总计划或同类文件中详细说明。
Article 3 All Qualification and validation activities should be planned in advance. The critical aspects of qualification and validation should be specified in a validation master plan (VMP) or an equivalent document.
第四条验证总计划应当包含以下信息：
（一）确认与验证的方针；
（二）确认与验证活动的组织机构及职责；
（三）待确认或验证项目的概述；
（四）文件格式，包括确认或验证方案和报告的格式；
（五）计划和日程安排；
（六）在确认与验证中偏差处理和变更控制的管理；
（七）保持持续验证状态的策略，包括必要的再确认和再验证；
（八）所引用的文件、文献。
Article 4 The VMP should include the following information:
1) Qualification and validation policy;
2) The organization structure and responsibilities in qualification and
validation activities;
3) An overview of the qualification and validation items;
4) Document format, including the format of the qualification or validation
protocols and reports;
5) Planning and scheduling;
6) Deviation handling and change control management in the qualification
and validation activities;
7) Strategy to maintain the validated status, including requalification and
revalidation, where applicable;
8) The referenced files and documents.
第五条对于大型和复杂的项目，可制订单独的项目验证总计划。
Article 5 For a large and complex project, a separate project VMP could be established.
第四章文件
Chapter Four Documentation
第六条确认与验证方案应当经过审核和批准。确认与验证方案应当详述关键要素和可接受标准。
Article 6 A qualification or validation protocol should be subject to review and approval. The qualification or validation protocol should define in detail the critical factors and the acceptance criteria.
第七条供应商或第三方提供的确认与验证的方案、数据或报告，企业应当对文件的适用性和符合性进行审核、批准。
Article 7 Where qualification and validation protocols are supplied by a supplier or a third party, the manufacturer should review their suitability and compliance before approval.
第八条确认或验证活动结束后，应当及时汇总分析获得的数据和结果，撰写确认或验证报告。企业应当在报告中对确认与验证过程中出现的偏差进行评估，必要时进行彻底调查，并采取相应的纠正措施和预防措施；对于已批准的确认与验证方案的变更，进行评估并采取相应的控制措施。确认或验证报告应当经过书面审核、批准。
Article 8 A qualification or validation report should be prepared in a timely manner, summarizing and analyzing the data and results obtained after qualification or validation activities are completed. The manufacturer should assess any deviations identified during the qualification and validation activities, and conduct a thorough investigation and take relevant corrective actions and preventive actions, if necessary. Any changes to an approved qualification or validation protocol should be assessed and relevant control measures should be taken. The qualification and validation report should be reviewed and approved in written.
第九条当验证结果不符合预先设定的可接受标准时，应当进行记录并分析原因。企业如对原先设定的可接受标准进行调整，需进行科学评估，得出最终的验证结论。
Article 9 Any validation results that fail to meet the pre-defined acceptance criteria should be recorded and a cause analysis should be conducted. Any subsequent changes to the pre-defined acceptance criteria should be scientifically justified and a final validation conclusion should be made.
第十条当确认或验证分阶段进行时，只有当上一阶段的确认或验证活动符合预定目标且经书面批准后，方可进行下一阶段的确认或验证活动。上一阶段的确认或验证活动中某项预先设定标准不能满足或偏差处理未完成，经评估对下一阶段的确认或验证活动无重大影响，企业可对上一阶段的确认或验证活动进行有条件的批准。
Article 10 When the qualification or validation are conducted by phases, only when the qualification or validation activities of a proceeding phase meet the pre-defined objectives and are approved in written, can the qualification or validation activities of the subsequent phase be started. A conditional approval to proceed to the next phase can be given by the manufacturer where certain pre-defined criteria can not be met or deviations have not been fully closed in the last qualification or validation phase and there is an assessment concluding that there is no significant impact on the next qualification or validation phase.
第五章确认
Chapter Five Qualification
第一节设计确认
Design Qualification
第十一条企业应当对新的厂房、设施、设备按照预定用途和本规范及相关法律法规要求制定用户需求，并经审核、批准。
Article 11 The user requirement specification (URS) for a new facility, system or equipment should be defined according to the pre-defined usage, the requirements of this guideline and the relevant regulations and laws. The URS should be reviewed and approved.
第十二条设计确认应当证明设计符合用户需求，并有相应的文件。
The design qualification should prove and document that the design meets the URS requirements.
第二节安装确认
Installation Qualification (IQ)
第十三条新的或改造的厂房、设施、设备需进行安装确认。
IQ should be performed for new or modified facilities, systems and equipment.
第十四条企业应当根据设计确认中的技术要求对厂房、设施、设备进行验收并记录。安装确认可包括但不限于以下方面：
The manufacturer should conduct and document an acceptance inspection on the facilities, systems and equipment according to the technical specifications of the DQ. IQ should include, but is not limited to the following:
（一）根据最新的工程图纸和技术要求，检查设备、管道、公用设施和仪器的安装是否符合设计标准；
(I) Check the installation of equipment, pipe work, utility services and instruments against the current engineering drawings and technical specifications to see whether the design specifications are met.
（二）收集及整理（归档）由供应商提供的操作指南、维护保养手册；
(II) Collect and collate (archive) the operating and maintenance manuals provided by the supplier.
（三）相应的仪器仪表应进行必要的校准。
(III) Relevant instruments should be calibrated as necessary.
第三节运行确认
Operational Qualification (OQ)
第十五条企业应当证明厂房、设施、设备的运行符合设计标准。运行确认可包括但不限于以下方面：
Article 15 The compliance of the operation of the facilities, systems and equipment with design specifications should be demonstrated by the manufacturer. OQ should include but is not limited to the following:
（一）根据设施、设备的设计标准制定运行测试项目。
(I) Tests developed based on the design specifications of the facilities, systems and equipment.
（二）试验/测试应在一种或一组运行条件之下进行，包括设备运行的上下限，必要时采用“最差条件”进行确认。
(II) Tests should be conducted under one type or one set of operation conditions, including the upper and lower operating limits, and “worst case” conditions should be used if necessary.
第十六条运行确认完成后，应当建立必要的操作、清洁、校准和预防性维护保养的操作规程，并对相关人员培训。
Article 16 After the completion of the OQ, necessary operation, cleaning, calibration and preventive maintenance SOPs should be established, and operators shall be trained.
第四节性能确认
Performance Qualification (PQ)
第十七条安装和运行确认完成并符合要求后，方可进行性能确认。在某些情况下，性能确认可与运行确认或工艺验证结合进行。
Article 17 PQ can be initiated only after the successful completion of IQ and OQ. In some cases, PQ can be performed in conjunction with OQ or Process Validation.
第十八条应当根据已有的生产工艺、设施和设备的相关知识制定性能确认方案，使用生产物料、适当的替代品或者模拟产品来进行试验/测试；应当评估测试过程中所需的取样频率。
Article 18 PQ protocol should be developed based on the knowledge of the process and the facilities, systems or equipment. And production materials, appropriate placebos or simulated products can be used for the tests. The frequency of sampling during testing should be assessed.
第六章工艺验证
Process Validation
第一节一般要求
General Requirement
第十九条工艺验证应当证明一个生产工艺按照规定的工艺参数能够持续生产出符合预定用途和注册要求的产品。工艺验证应当包括首次验证、影响产品质量的重大变更后的验证、必要的再验证以及在产品生命周期中的持续工艺确认，以确保工艺始终处于验证状态。
Article 19 The process validation should prove that the process, operated within the established parameters, can reproducibly produce a medicinal product meeting its predetermined usage and registration requirements. Process validation should cover the initial validation, the subsequent validation of critical changes which can impact
the product quality and necessary re-validation, and continuous process verification during the life-cycle of the product, ensuring the validated status of the process.
第二十条企业应当有书面文件确定产品的关键质量属性、关键工艺参数、常规生产和工艺控制中的关键工艺参数范围，并根据对产品和工艺知识的理解进行更新。
Article 20 The manufacturer should have a written document defining the critical quality attributes, critical process parameters, and critical process parameter ranges for routine production and process control, which should be updated based on the understanding of product and process knowledge.
第二十一条首次工艺验证应当涵盖该产品的所有规格及使用的生产线。企业可根据风险评估的结果采用简略的方式进行后续的工艺验证，如选取有代表性的产品规格或包装规格、最差工艺条件进行验证，或适当减少验证批次。
Article 21 The initial process validation should cover all the strengths and the production lines used. The abbreviated approach can be applied for subsequent process validation by the manufacturer based on the risk assessment results. For example, the representative strength or packing size, the worst process conditions can be selected for the validation. Or the number of validation bathes can be reduced appropriately.
第二十二条工艺验证批的批量一般应当与预定的商业批的批量一致，当批量不一致时，应当进行评估。
Article 22 Normally batches manufactured for process validation should be of the same size as the intended commercial scale batches and the use of any other batch sizes should be justified.
第二十三条工艺验证前至少应当完成以下工作：
Article 23 At least the following works should be completed prior to process validation:
（一）厂房、设施、设备经过确认并符合要求，分析方法经过验证或确认。
(I) Facilities, systems, utilities and equipment used for process validation should be qualified and the analytical methods should be validated or qualified.
（二）日常生产操作人员应当参与工艺验证批次生产，并经过适当的培训。
(II) Routine production operators should be involved in the production of process validation batches and they shall be appropriated trained.
（三）用于工艺验证批次生产的关键物料应当由批准的供应商提供，否则需评估可能存在的风险。
The critical starting and packaging materials used for the manufacture of validation batches should be provided by qualified suppliers. Otherwise the possible quality risks should be assessed.
第二十四条企业应当根据质量风险管理原则确定工艺验证批次数和取样计划，以获得充分的数据来评价工艺和产品质量。
Article 24 The number of batches to be manufactured and the number of samples to be taken should be determined based on quality risk management principles by the manufacturer, to obtain sufficient data for the evaluation of process and product quality.
第二十五条如未按照第二十四条要求进行预先的风险评估，企业应当至少进行连续三批成功的工艺验证。对产品生命周期中后续商业生产批次获得的信息和数据，进行持续的工艺确认。
Article 25 If the above mentioned risk assessment is not performed following Articles 24, a minimum of three consecutive successful batches should be produced
by the manufacturer for the validation of the process. An on-going process verification should be conducted based on the information and data obtained from subsequent commercial batches during the product life-cycle.
第二十六条工艺验证方案应当至少包括以下内容：
Article 26 A process validation protocol should include, but are not limited to the following:
（一）工艺的简短描述；
(I) A short description of the process.
（二）关键质量属性的概述及可接受限度；
(II) A summary of the CQAs and their acceptance criteria.
（三）关键工艺参数的概述及可接受限度；
(III) A summary of the CPPs and their acceptance criteria.
（四）应当进行验证的其它质量属性和工艺参数的概述；
(IV) A summary of other quality attributes and process parameters which will be validated.
（五）所要使用的设备、设施清单（包括称量、监控和记录设备）以及它们的校准
状态；
(V) A list of the equipment/facilities to be used (including measuring/monitoring/recording equipment) and their calibration status.
（六）成品放行的质量标准；
(VI) Finished product release specifications
（七）相应的检验方法清单；
(VII) A list of relevant analytical methods.
（八）中间控制参数及可接受标准；
(VIII) In-process controls with their acceptance criteria.
（九）拟进行的额外试验，以及测试项目的可接受标准，和已验证的用于测试的分
析方法；
(IX) The proposed additional tests to be carried out, with their acceptance criteria, and validated analytical methods for validation.
（十）取样方法及计划；
(X) The sampling methods and plan
（十一）记录和评估结果的方法（包括偏差处理）；
(XI) The methods for recording and evaluating results (including deviation handling).
（十二）职能部门和职责；
(XII) The functional departments and responsibilities.
（十三）建议的时间进度表。
(XIII) The proposed schedule.
第二十七条如企业从生产经验和历史数据中已获得充分的产品和工艺知识并有
深刻理解，工艺变更后或持续工艺确认等验证方式，经风险评估后可进行适当的调整。
Article 27 Where there is sufficient product and process knowledge and a thorough understanding gained from manufacturing experience and historical batch data, the validation approach for validation activities after a process change or during
ongoing process verification can be adjusted appropriately based on risk assessment results.
第二节持续工艺确认
Continuous Process Verification
第二十八条在产品生命周期中，对商业化生产的产品质量进行监控和趋势分析，以确保工艺和产品质量始终处于控制状态。
Article 28 Manufacturers should monitor product quality and analysis the trend to ensure that process and product quality is always within a state of control throughout the product lifecycle.
第二十九条在产品生命周期中，考虑到对于工艺的理解和工艺性能控制水平的变化，应当对持续工艺确认的范围和频率进行周期性的审核和调整。
Article 29 The extent and frequency of ongoing process verification should be reviewed periodically and modified, considering the changing in the level of process understanding and the process performances in the product lifecycle.
第三十条持续工艺确认应当按照批准的方案进行，并根据获得的结果形成相应的报告。必要性，应当使用统计工具进行数据分析，以确认工艺处于控制状态。
Article 30 Continuous process verification should be conducted based on an approved protocol and a corresponding report should be prepared based on the results obtained. Statistical tools should be used, where appropriate, to analyze the data and ensure the process is always under control.
第三十一条在产品质量回顾过程中应当采用持续工艺确认的方法支持产品的验证状态，还要考虑当趋势出现渐进性变化时，应当进行评估并采取相应的措施。
Article 31 Continuous process verification should be used to support the validated status of the product during Product Quality Review. However, incremental changes over time should also be considered and the need for any relevant actions should be assessed and taken.
第三节同步验证
Concurrent Validation
第三十二条在极个别情况下，允许进行同步验证。如因药物短缺可能增加患者健康风险、因产品的市场需求量极小而无法连续进行验证批次的生产。
Article 32 Concurrent validation can be carried out in exceptional circumstances, such as when patient health risks may be increased due to the shortage of a medicinal product, validation batches cannot be manufactured continuously due to the very small market demand.
第三十三条对进行同步验证的决定必须证明其合理性、并经过质量管理负责人员的批准。
Article 33 The decision to carry out concurrent validation must be justified and approved by a quality management responsible personnel.
第三十四条因同步验证批次产品的工艺和质量评价尚未全部完成产品即已上市，企业应当增加对验证批次产品的监控。
Article 34 The products have been put on the market already when the process and quality evaluation on the concurrent validation batches have not been completed yet, so manufacturers should enhance the monitoring of the products of the validation
batches.
第七章运输确认
Transportation Verification
第三十五条对运输有特殊要求的物料和产品，其运输条件应当符合相应的批准文件、质量标准中的规定或企业（或供应商）的要求。
Article 35 The transportation conditions of materials and products having special transportation requirements should meet the requirements specified in the corresponding approval document and specifications or the manufacturer (or suppliers) requirements.
第三十六条运输确认应当对运输涉及的影响因素进行挑战性测试，且应当明确规定运输途径，包括运输方式和路径。长途运输还应当考虑季节变化的因素。
Article 36 During the transportation verification a challenge test on the impact factors involved in transportation should be performed. Transportation methods should be clearly defined, including mode and routes of transportation. For long-distance transportation, seasonal changes should also be considered.
第三十七条除温度外还应当考虑和评估运输过程中的其它相关因素对产品的影响，如湿度、震动、操作、运输延误、数据记录器故障、使用液氮储存、产品对环境因素的敏感性等。
Article 37 Besides the temperature, an assessment should also be performed to consider the impact of other relevant factors on the products during transportation, such as humidity, vibration, handling, delays during transportation, failure of data-loggers, topping up liquid with Nitrogen, product susceptibility to the environment, etc.
第三十八条在产品运输过程中可能会遇到各种不可预计的情况，运输确认应当对关键环境条件进行连续监控。
Article 38 Various conditions may be encountered during transportation, and all the critical environmental conditions should be monitored continuously.
第八章清洁验证
Cleaning Validation
第三十九条为确认与产品直接接触设备的清洁操作规程的有效性，应当进行清洁验证。应当根据所涉及的物料，合理地确定活性物质残留、清洁剂和微生物污染的限度标准。
Article 39 Cleaning validation should be performed in order to confirm the effectiveness of a cleaning procedure for a piece of equipment in direct contact with the product. The limits of carryover product residues, cleaning agents and microbial contamination should be reasonably defined based on the materials involved.
第四十条在清洁验证中，不能采用反复清洗“至清洁”的方法。目视检查是一个很重要的标准，但通常不能作为单一可接受标准使用。
Article 40 Repeated cleaning “until clean” is not allowed as the acceptance criteria in cleaning validation. A visual inspection for cleanliness is an important part of the acceptance criteria for cleaning validation. However, generally it cannot be used as the only acceptable criterion.
第四十一条清洁验证的批次数应当根据风险评估确定。
清洁验证计划完成需要一定的时间，验证过程中每个批次后的清洁效果需及时进行确认。必要时，企业在清洁验证后应当对设备的清洁效果进行持续确认。
Article 41 The number of batches for cleaning validation should be determined based on a risk assessment
It is recognised that a cleaning validation programme may take some time to complete and the cleaning effect after each batch needs to be verified timely. Continuous verification on the cleaning effect of equipment should be conducted by manufacturers after cleaning validation.
第四十二条验证应当考虑清洁方法的自动化程度。当采用自动化清洁方法时，应当对所用清洁设备设定的正常操作范围进行验证；当使用人工清洁程序时，应当评估影响清洁效果的各种因素，如操作人员、清洁规程详细程度（如淋洗时间等），对于人工操作而言，如果明确了可变因素，在清洁验证过程中应当考虑相应的最差条件。
Article 42 For validation the level of automation in the cleaning process should be considered. Where an automatic cleaning process is used, the specified normal operating range of the cleaning equipment should be validated. Where a manual process is used, an assessment should be performed to determine the various factors that can influence the cleaning effect, such as the operators, and the level of detail in the procedures like rinsing times etc. For manual cleaning, if variable factors have been identified, the worst case conditions should be considered during the cleaning validation.
第四十三条活性物质允许日接触量的确定应当基于毒理学的评估，以此设定活性物质残留的限度标准。允许日接触量的确定应当基于文献资料进行风险评估。所使用的清洁剂的清除方法也应当进行确认。
Article 43 Limits for the carryover of product residues should be determined based on a toxicological evaluation to determine the product’s specific permitted daily exposure (PDE) value. The justification for the selected PDE value should be documented in a risk assessment which should include all the supporting references. The removal of any cleaning agents used should also be verified.
可接受标准应当考虑工艺设备链中多个设备潜在的累积效应。
Acceptance criteria should be determined considering the potential cumulative effects of multiple pieces of equipment in the process equipment train.
第四十四条应当在清洁验证过程中对潜在的微生物污染进行评价，如需要，还应当评价细菌内毒素污染。应当考虑设备使用后至清洁前的间隔时间以及设备清洁后的保存时限对清洁验证的影响。
Article 44 The potential microbial and, if relevant, endotoxin contamination should be assessed during cleaning validation. The influence of the dirty hold time after equipment use to equipment cleaning and the clean hold time after equipment cleaning on the cleaning validation should be considered.
第四十五条当采用阶段性生产组织方式时，应当考虑阶段性生产的最长时间和最大批次数量，以作为清洁验证的评价依据。
Article 45 Where campaign manufacture is carried out, the impact on the ease of cleaning between batches should be considered and the maximum length of a campaign (in both time and number of batches) should be the assessment basis for cleaning validation exercises.
第四十六条当采用最差条件产品的方法进行清洁验证模式时，最差条件产品的选择依据应当进行评价，当生产线引入新产品时，需再次进行评价。如多用途设备没有单一的最差条件产品时，最差条件的确定应当考虑产品毒性、允许日接触剂量和溶解度等。
每个使用的清洁方法都应当进行最差条件验证。
Article 46 Where a worst case product approach is used as a cleaning validation model, the rationale for the selection of the worst case product should be justified and reassessment need to be conducted if new products is to be introduced. When there is no single worst case product when using multi-purpose equipment, the choice of worst cases should consider toxicity and PDE value as well as solubility. Worst case cleaning validation should be performed for each cleaning method used.
在同一个工艺步骤中，使用多台同型设备生产，企业可在评估后选择有代表性的设备进行清洁验证。
When multiple pieces of equipment of the same type are used in one process step, the cleaning validation for the representative equipment can be performed by the manufacturer.
第四十七条清洁验证方案应当详细描述取样的位置、所选取的取样位置的理由以及可接受标准。
Article 47 The cleaning validation protocol should detail the sampling locations and the rationale for the selection of these locations and define the acceptance criteria.
第四十八条应当采用擦拭取样和（或）对清洁最后阶段的淋洗水取样，或者根据取样位置确定的其他取样方法取样。擦拭用的材料不应当对结果有影响。如果采用淋洗的方法，应当在清洁程序的最后淋洗时进行取样。企业应当评估从设备所用各种材质进行取样的方法有效性。
Article 48 Sampling should be carried out by swabbing and/or rinsing at the last stage of cleaning or by other means depending on the sampling location. The swab material should not influence the result. If the rinse method is used, the sampling should be performed during the final rinse in the cleaning procedures. Recovery should be shown to be possible from all materials used in the equipment with all the sampling methods used.
第四十九条对于处于研发阶段的药物或不经常生产的产品，可采用每批生产后确认清洁效果的方式替代清洁验证。每批后的清洁确认应当根据本附录的相关要求进行。
Article 49 For investigational medicinal products or products which are only manufactured infrequently, cleaning effect verification may be used instead of cleaning validation. If used, cleaning verification after each batch should be based on the principles in this Annex.
第五十条如无法采用清洁验证的方式来评价设备清洁效果，则产品应当采用专用设备生产。
Article 50 Where cleaning validation is not appropriate for some equipment, dedicated equipment should be used for each product.
第九章再确认和再验证
Chapter Nine Requalification and Revalidation
第五十一条对设施、设备和工艺，包括清洁方法应当进行定期评估，以确认它们持续保持验证状态。
Article 51 Facilities, equipment and process (including cleaning methods) should be evaluated at an appropriate frequency to confirm that they remain in a validated state.
第五十二条关键的生产工艺和操作规程应当定期进行再验证，确保其能够达到预
期效果。
Article 52 Critical process and operational procedures should be revalidated at an appropriate frequency to confirm the expected effect to be achieved
第五十三条应当采用质量风险管理方法评估变更对产品质量、质量管理体系、文件、验证、法规符合性、校准、维护和其它系统的潜在影响，必要时，进行再确认或再验证。
Article 53 Quality risk management approach should be applied to assess the potential impact of changes on product quality, quality management system, documentation, validation, regulatory compliance, calibration, maintenance and other systems. Requalification or revalidation is required, if necessary.
第五十四条当验证状态未发生重大变化，可采用对设施、设备和工艺等的回顾审核，来满足再确认或再验证的要求。当趋势出现渐进性变化时，应当进行评估并采取相应的措施。
Article 54 A retrospective review of the facilities, equipment and process can be used to satisfy the requirements of requalification or revalidation if no critical changes occurred to validation status. Evaluation should be carried out and measures should be taken if the trend has a progressive change.
第十章术语
Chapter Ten Glossary
（一）安装确认Installation Qualification
为确认安装或改造后的设施、系统和设备符合已批准的设计及制造商建议所作的各种查证及文件记录。
The documented verification and recording of that the facilities, systems and equipment, as installed or modified, comply with the approved design specifications and the manufacturer’s recommendations.
（二）持续工艺确认 Continuous Process Verification
在产品生命周期中，对商业化生产的产品质量进行监控和趋势分析，以确保工艺和产品质量始终处于控制状态。
The quality of the commercial products is continuously monitored and trend analyzed throughout the lifecycle of the product to ensure that the process and product quality remain in a state of control.
（三）关键质量属性 Critical Quality Attribute
指某种物料、化学、生物学或微生物学的性质，应当有适当限度、范围或分布，保证预期的产品质量。
A physical, chemical, biological or microbiological property or characteristic that should be controlled within an appropriate limit, range or distribution to ensure that the desired product quality can be obtained
（四）工艺验证 Process Validation
为证明工艺在设定参数范围内能有效稳定地运行并生产出符合预定质量标准和质量特性药品的验证活动。
The validation activity in order to prove that the process, operated within established parameters, can perform effectively and steadily to produce a medicinal product meeting its predetermined specifications and quality attributes.
（五）模拟产品 Simulated Product
与被验证产品物理性质和化学性质十分相似的产品。在很多情况下，安慰剂产品的批可满足理化特征的要求。
A material that closely approximates the physical and the chemical characteristics of the product under validation. In many cases, these characteristics may be satisfied by a placebo product batch.
（六）清洁验证 Cleaning Validation
有文件和记录证明所批准的清洁规程能有效清洁设备，使之符合药品生产的要求。
Cleaning validation is to establish documented evidence verifying that an approved cleaning procedure can be used to clean the equipment effectively to meet the requirement of drug production.
（七）设计确认 Design Qualification
为确认设施、系统和设备的设计方案符合期望目标所作的各种查证及文件记录。
The verification and documentation showing that the proposed design of the facilities, systems and equipment is suitable for the intended purpose.
（八）同步验证Concurrent Validation
在商业化生产过程中进行的验证，验证批次产品的质量符合验证方案中所有规定的要求，但未完成该产品所有工艺和质量的评价即放行上市。
Validation carried out during commercial production, where the quality of the validation batches meets all the requirements defined in the validation protocol, and the products have been put on the market when the process and quality evaluation are still not completed.
（九）性能确认Performance Qualification
为确认已安装连接的设施、系统和设备能够根据批准的生产方法和产品的技术要求有效稳定（重现性好）运行所作的试车、查证及文件记录。
The trial run, verification and documentation showing that the facilities, systems and equipment, as connected and installed together, can perform effectively and reproducibly, based on the approved process and product technical specifications.
（十）用户需求 User Requirements
是指使用方对厂房、设施、设备或其它系统提出的要求及期望。
The requirements and expectations on facilities, systems and equipment provided by the user
（十一）运行确认 Operational Qualification
为确认已安装或改造后的设施、系统和设备能在预期的范围内正常运行而作的试车、查证及文件记录。
The trail run, verification and documentation showing that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.
（十二）最差条件 Worst Case
在SOP范围内（或超出），由工艺参数的上、下限和相关因素组成的一个或一系列条件。与理想条件相比时，最差条件使产品或者生产工艺失败的几率为最大，这样的条件不一定导致产品或生产工艺的失败。
A condition or set of conditions encompassing upper and lower processing limits and circumstances within (or exceed) standard operating procedures which pose the greatest chance of product or process failure when compared to ideal conditions. Such conditions do not necessarily induce product or process failure