ASTME250007中英文對照

1、ASTM E2500-07 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment 1This standard is issued under the fixed designation E 2500; the number immediately following the designation indicates the year of original adoption o

2、r, in the case of revision. A number in parentheses indicates the year of last re-approval. A superscript epsilon () indicates an editorial change since the last revision or re-approval.制藥、生物制藥生產(chǎn)系統(tǒng)和設(shè)備的規(guī)范、設(shè)計、驗證標準指南這個標準出版的固定名稱是E2500;名稱后緊接的數(shù)字表示最初版本的年份，或修訂的情況。括號中的數(shù)字表示最近一次重新批準的年份。上標()表示自從最近一次修訂或重新批準以來，編輯

3、修改情況。1. Scope范圍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 a

4、nd patient safety.1.1本指南適用于制藥和生物制藥生產(chǎn)系統(tǒng)中，可能影響產(chǎn)品質(zhì)量和病人安全的所有要素，其中包括：設(shè)施設(shè)備，公用支持系統(tǒng)，相關(guān)過程的監(jiān)控和控制系統(tǒng)，自動化系統(tǒng)。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

5、.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 conce

6、pt to retirement.1.2簡要的說，這是一個全國通用的有關(guān)生產(chǎn)系統(tǒng)的小指南。1.3本指南也可以適用于實驗室，信息和醫(yī)療設(shè)備制造系統(tǒng)。1.4本指南適用于新的和現(xiàn)有的生產(chǎn)系統(tǒng)。該方法可用于實行對現(xiàn)有系統(tǒng)的變更，并實現(xiàn)運行過程中，對現(xiàn)有系統(tǒng)的持續(xù)改進。1.5本指南適用于生產(chǎn)系統(tǒng)從概念到報廢的整個生命周期。1.6 This standard does not address employee health and safety, environmental, or other non-GXP regulations. This standard does not purport to a

7、ddress 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該標準不涉及討論雇員的健康和安全，環(huán)境，或其他非GXP的規(guī)定。這一標準不是討論所有的安全問題，如果有的

8、話，與其使用相關(guān)。本標準的使用者的職責(zé)，是建立適當(dāng)?shù)陌踩托l(wèi)生標準，并在使用前確定限制性規(guī)范的適用性。2. Reference Documents參考文獻2.1 ASTM Standards: 2E 2363 Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry2.2 Other Publications:ICH Q8 Pharmaceutical Development Handbook3ICH Q9 quality Risk Handbook3Pharmaceutical c

9、GMPs for the 21st CenturyA Risk-Based Approach42.1美國試驗與材料協(xié)會標準（簡稱：ASTM標準）E 2363制藥工業(yè)過程分析技術(shù)的有關(guān)術(shù)語2.2其它出版物ICH Q8 藥品研發(fā)手冊ICH Q9 質(zhì)量風(fēng)險管理手冊21世紀藥品CGMP基于風(fēng)險管理方法3. Terminology術(shù)語3.1 DefinitionsFor definitions of terms used in this guide, refer to Terminology E 2363.定義-這個指南中使用的術(shù)語的定義，請參閱E2363術(shù)語部分。3.1.1acceptance cri

10、teriathe criteria that a system or component must satisfy in order to be accepted by a user or other authorized entity.驗收標準這個標準必須確保某一系統(tǒng)或組件能夠被使用者或其他授權(quán)機構(gòu)所接受。3.1.2design reviewsplanned and systematic reviews of specifications, design, and design development and continuous improvement changes performed

11、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.設(shè)計回顧在整個生產(chǎn)系統(tǒng)的生命周期中，有計劃、系統(tǒng)地對規(guī)范、設(shè)計、設(shè)計開發(fā)和持續(xù)改進情況進行適當(dāng)?shù)幕仡檶彶?。設(shè)計回顧可根據(jù)標準和要求，交付評價，找出問題，并提出必要的糾正措施。3.1.3manufa

12、cturing systemselements 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

13、 quality and patient safety.生產(chǎn)系統(tǒng)-制藥和生物制藥生產(chǎn)能力的各要素，包括生產(chǎn)系統(tǒng)，設(shè)施設(shè)備，工藝設(shè)備，公共支持系統(tǒng)，相關(guān)的過程監(jiān)測和控制系統(tǒng)，自動化系統(tǒng)，所有這些，都有可能影響產(chǎn)品質(zhì)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, o

14、perations, and so forth).相關(guān)領(lǐng)域的專家（SMEs）-在某一特定領(lǐng)域或方面（例如，質(zhì)量部門，工程學(xué)，自動化技術(shù)，研發(fā)，經(jīng)營，等等），個人擁有的資格和特殊技能。3.1.5 verificationa 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 um

15、brella 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.驗證-是一個系統(tǒng)的方法，用來證實生產(chǎn)系統(tǒng)、單獨或聯(lián)合操作，是否符合其預(yù)定用途，是否已正確安裝，并正確運行。這是一個總稱，它包括所有確保系統(tǒng)適合其用途的方法，如確認，調(diào)試和確認，驗證，系統(tǒng)驗證或其他。1 This guide unde

16、r 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委員會E55（醫(yī)藥產(chǎn)品的生產(chǎn)）管轄, 具體由E55.03（一般的藥品標準）小組委員會直接負責(zé)。當(dāng)前版本2007年6

17、月1日批準。2007年8月出版。2 For referenced ASTM standards, visit the ASTM website, www. astm. org, or contact ASTM Customer Service at . for Annual Book of ASTM Standards volume information, refer to the standards Document Summary page on the ASTM website.有關(guān)ASTM標準，請訪問ASTM的網(wǎng)站，. 或聯(lián)系A(chǔ)S

18、TM客戶服務(wù)網(wǎng)站 . ASTM標準的年刊信息，請參閱ASTM網(wǎng)站上本標準的文件摘要頁。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.

19、org.可聯(lián)系人用藥品注冊技術(shù)要求國際協(xié)調(diào)會(ICH), 轉(zhuǎn)ICH秘書處，IEPMA,15號。郵政信箱Louis-Dunant 195,1211 Geneva 20，Switzerland、。4 Available from Food and Drug Administration(FDA),5600 Fishers Ln., Rockville, MD 20857, .可聯(lián)系美國食品藥品管理局(FDA), Fishers Ln., Rockville, MD 20857, .4. Summa

20、ry of Guide4.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. 本指南以風(fēng)險和科學(xué)為基礎(chǔ)的方法，對潛在可能影響產(chǎn)品質(zhì)量和病人安全的生產(chǎn)系統(tǒng)和設(shè)備的規(guī)范，設(shè)計和驗證進行描述。4.2 This

21、 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

22、.本指南描述了一個系統(tǒng)的、高效的和有效的方式，確保生產(chǎn)系統(tǒng)和設(shè)備符合預(yù)期的使用目的，而且對關(guān)乎產(chǎn)品質(zhì)量和隨后病人安全的風(fēng)限進行有效管理，受系統(tǒng)和設(shè)備影響的風(fēng)險都在范圍內(nèi)。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. 總的目標是提供生產(chǎn)能力，以支持明確的、受控的工藝能夠持續(xù)生產(chǎn)

23、出符合質(zhì)量規(guī)范的產(chǎn)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). 在本指南內(nèi)描述的方法還支持生產(chǎn)工藝能力的持續(xù)改進，實現(xiàn)創(chuàng)新，如運用過程分析技術(shù)（PAT）4.5 The main elements of this guide are: 4.5.1 The un

24、derlying 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以下根本的關(guān)鍵概念必須應(yīng)用，4.5.2一個對規(guī)范，設(shè)計和驗證過程的描述4.5.3一個對必需的輔助性工藝的描述5. Significance and Use意義和用途5.1 Application of

25、 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 guid

26、e applies concepts and principles introduced in the FDA initiative, Pharmaceutical cGMPs for the 21st CenturyA 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這個指南中所描述的方法的應(yīng)用，目的是為了滿足國際規(guī)范所期望的那樣：使

27、生產(chǎn)系統(tǒng)和設(shè)備符合預(yù)期的用途，滿足設(shè)計，安裝，運行及性能的要求。5.2本指南中描述的方法所運用的概念和原理，在FDA發(fā)起的，21世紀藥品生產(chǎn)cGMPs-一個基于風(fēng)險分析的方法中有介紹。5.3本指南可單獨使用或與ASTM國際部出版的E55號標準聯(lián)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 G

28、ood Engineering Practice Subject Matter Expert Use of Vendor Documentation Continuous Process Improvement6.1本指南使用以下重要概念： 基于風(fēng)險的方法 基于科學(xué)的方法 生產(chǎn)系統(tǒng)的關(guān)鍵方面 質(zhì)量源于設(shè)計 良好的工程實踐 專門領(lǐng)域的專家 供應(yīng)商文件的使用 工藝持續(xù)改進6.2 Risk-based Approach: 6.2.1 Risk management should underpin the specification, design, and verification process,

29、 and be applied appropriately at each stage. 6.2.2 Two primary principles of quality risk management are identified in ICH Q9: The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient. The level of effort, formal

30、ity 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

31、 verification activities and documentation should be based on the risk to product quality and patient safety. 6.2基于風(fēng)險的方法6.2.1風(fēng)險管理應(yīng)該支持規(guī)范，設(shè)計和驗證過程，并在每一階段適當(dāng)應(yīng)用。6.2.2在ICH Q9中明確了質(zhì)量風(fēng)險管理的兩個基本原則：質(zhì)量風(fēng)險評價必須以科學(xué)知識為基礎(chǔ)，并最終與保護病人安全相聯(lián)系。質(zhì)量風(fēng)險管理實施的力度、形式和文件必須與風(fēng)險級別（程度）相匹配。6.2.3這些原理必須應(yīng)用于生產(chǎn)系統(tǒng)的規(guī)范，設(shè)計和驗證。6.2.4與規(guī)范、設(shè)

32、計、驗證有關(guān)的質(zhì)量風(fēng)險管理和文件系統(tǒng)的廣度和深度，都必須以產(chǎn)品質(zhì)量風(fēng)險和病人安全為基礎(chǔ)。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 veri

33、fied 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基于科學(xué)的方法6.3.1產(chǎn)品和工藝的信息，如果與產(chǎn)品質(zhì)量和病人安全有關(guān)，都必須作為科學(xué)風(fēng)險

34、決策的基礎(chǔ)，確保生產(chǎn)系統(tǒng)設(shè)計和驗證至符合其預(yù)定用途。6.3.2例如，應(yīng)考慮的產(chǎn)品和工藝信息的包括：關(guān)鍵質(zhì)量屬性（ CQAs ），關(guān)鍵工藝參數(shù)（CPPs），過程控制策略信息，和以往的生產(chǎn)經(jīng)驗。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 manufacturi

35、ng 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

36、 should focus on these aspects of manufacturing systems and should be documented. The verification process is defined in 生產(chǎn)系統(tǒng)的關(guān)鍵方面：6.4.1生產(chǎn)系統(tǒng)的關(guān)鍵方面通常是功能，特征，性能，和持續(xù)保持產(chǎn)品質(zhì)量和病人安全所必須的生產(chǎn)工藝和系統(tǒng)的性能或特征。他們應(yīng)該在科學(xué)的產(chǎn)品和工藝的理解基礎(chǔ)上進行確定并記錄。6.4.2簡而言之，作為關(guān)鍵方面，可參閱本指南的其余部分。6.4.3驗證事務(wù)應(yīng)側(cè)重于生產(chǎn)系統(tǒng)的這些方面，并應(yīng)記錄在案。工藝驗證參見7.4。6.5 Qual

37、ity by Design: 質(zhì)量源于設(shè)計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. 在規(guī)范和工藝設(shè)計過程中，必須應(yīng)用質(zhì)量源于設(shè)計的概念，確保關(guān)鍵方面都設(shè)計入

38、系統(tǒng)中。設(shè)計的關(guān)鍵方面和相關(guān)驗收標準應(yīng)記錄在案。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. 確保生產(chǎn)系統(tǒng)符合其預(yù)期的用途，不能僅僅依賴于安裝后的驗證，而是應(yīng)做到將有計劃，

39、有組織的驗證方法應(yīng)用于系統(tǒng)的整個生命周期。6.6 Good Engineering Practice: 良好的工程實踐：6.6.1 Good Engineering Practice (GEP) should underpin and support the specification, design, and verification activities. 良好的工程實踐（GEP）應(yīng)當(dāng)鞏固和支持規(guī)范，設(shè)計和驗證活動6.6.2 Good Engineering Practice is defined as those established engineering methods and s

40、tandards that are applied throughout the life cycle to deliver appropriate and effective solutions.良好的工程實踐定義為，那些為得到適當(dāng)和有效的解決辦法，而建立工程方法和應(yīng)用于整個生命周期的標準。6.6.3 Examples of Good Engineering Practices include:6.6.3良好的工程實踐例子包括： Specification, design, and installation activities should take full account

41、 of all applicable requirements, including GXP, safety, health, environmental, ergonomic, operational, maintenance, recognized industry standards, and other statutory requirements. 規(guī)范，設(shè)計和安裝活動應(yīng)充分考慮到所有適用的要求，包括GXP，安全，衛(wèi)生，環(huán)境，人類工程學(xué)，操作，維護，公認的行業(yè)標準，和其他法定要求. Adequate provisions related to quali

42、ty should be included in specification, design, procurement, and other contractual documents. 在規(guī)范，設(shè)計，采購，和其他合同文件中應(yīng)包括有足夠的與質(zhì)量有關(guān)的條款。 Life-cycle documentation covering planning, specification, design, verification, installation, acceptance, and maintenance should be produced. 必須制定涵蓋計

43、劃，規(guī)范，設(shè)計，驗證，安裝，驗收，維保等整個生命周期的文件。 An appropriate degree of oversight and control should be achieved by suitable verification of execution, construction and installation activities. 對實施驗證，施工和安裝等活動進行合適的確認，達到適當(dāng)程度的監(jiān)督和控制。6.7 Subject Matter Experts: 6.7相關(guān)領(lǐng)域的專家：6.7.1 Subject matter experts are d

44、efined 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相關(guān)領(lǐng)域?qū)＜业亩x是，那些在特定領(lǐng)域里有專業(yè)技能和資質(zhì)的人（例如質(zhì)量部門，工程，自動化技術(shù)，研發(fā)，生產(chǎn)等）。6.7.2 Subject matter experts should take the lea

45、d role in the verification of manufacturing systems as appropriate within their area of expertise and responsibility. 6.7.2相關(guān)領(lǐng)域?qū)＜?，在他們相?yīng)的專業(yè)技能和資格領(lǐng)域內(nèi)，在生產(chǎn)體系驗證中起帶頭作用。6.7.3 Subject matter expert responsibilities include planning and defining verification strategies, defining acceptance criteria, selection

46、 of appropriate test methods, execution of verification tests, and reviewing results. 6.7.3相關(guān)領(lǐng)域?qū)＜业穆氊?zé)，包括計劃和制定驗證策略，制定驗收標準，選擇適當(dāng)?shù)臏y試方法，實施驗證測試并評價結(jié)果。6.8 Use of Vendor Documentation: 6.8供應(yīng)商文件的使用：6.8.1 Vendor documentation, including test documents may be used as part of the verification documentation, provi

47、ding the regulated company has assessed the vendor, and has evidence of: 6.8.1供應(yīng)商文件（包括一些測試文件），都可用作驗證文件的一部分，只要供應(yīng)商經(jīng)負法律責(zé)任的公司評價，并且證明： An acceptable vendor quality system, 有一個可接受的供應(yīng)商質(zhì)量體系 Vendor technical capability, and 供應(yīng)商具技術(shù)能力，并且 Vendor application of GEP such that in

48、formation obtained from the vendor will be accurate and suitable to meet the purpose of verification. 供應(yīng)商應(yīng)用GEP，因而從供應(yīng)商獲得的有關(guān)信息是準確的和合適的并符合驗證目標。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 mitig

49、ate potential risks by applying specific, targeted, additional verification checks or other controls rather than repeating vendor activities and replicating vendor documentation. 6.8.2如果在供應(yīng)商質(zhì)量體系，技術(shù)能力或GEP應(yīng)用中發(fā)現(xiàn)有不足之處，負法律責(zé)任的公司可通過應(yīng)用特定的、有針對性的、額外的驗證檢查，或其它控制方式來轉(zhuǎn)移風(fēng)險，而不是重復(fù)供應(yīng)商的行為和復(fù)制供應(yīng)商文件。6.8.3 The decision and

50、 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使用供應(yīng)商文件來支持生產(chǎn)要素關(guān)鍵方

51、面的驗證的決定和判斷，必須以生產(chǎn)系統(tǒng)的預(yù)期用途為基礎(chǔ)，必須記錄在案并經(jīng)過相關(guān)專業(yè)領(lǐng)域?qū)＜遥òㄙ|(zhì)量部門）認可。6.9 Continuous Improvement: 6.9持續(xù)改進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 fail

52、ures. 6.9.1當(dāng)在商業(yè)化生產(chǎn)中積累一定的經(jīng)驗后，應(yīng)在周期性的回顧評價、性能數(shù)據(jù)以及分析失敗的根本原因的基礎(chǔ)上，尋找機會改進工藝。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變更管理應(yīng)遵循本指南中所描述

53、的規(guī)范，設(shè)計和驗證方法，為迅速實施合理的技術(shù)改進，提供一個可靠的機制。7. Process工藝7.1 OverviewThe process of specification, design, and verification of manufacturing systems should include the following activities: 概述-生產(chǎn)系統(tǒng)的規(guī)范，設(shè)計和驗證過程應(yīng)當(dāng)包括下列活動： Requirements definition 明確需求 Specification and design 規(guī)范和設(shè)計 Verification 驗證 Acceptance and r

54、elease 驗收和放行7.1.1 Good Engineering Practice should be applied throughout the process. 7.1.1整個生產(chǎn)工藝都必須應(yīng)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 m

55、anagement is a supporting process and is defined in 8.2. 風(fēng)險管理應(yīng)對生產(chǎn)系統(tǒng)中與產(chǎn)品質(zhì)量和患者安全相關(guān)的風(fēng)險進行適當(dāng)?shù)脑u估，并提出相應(yīng)的設(shè)計方案。風(fēng)險管理是一個輔助性工藝，在8.2中有對它的描述。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 defin

56、ed 8.3. 7.1.3適當(dāng)?shù)脑O(shè)計審核應(yīng)貫穿整個生產(chǎn)系統(tǒng)的生命周期。設(shè)計審核是一個輔助性工藝，在8.3中有對它的描述。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整個過程還必須應(yīng)用變更管理，變更管理是也是一個輔助性工藝，在8.4中有對它的描述。7.2 Requirements Definition:7.2.1 Specific requirements

57、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: Product knowledge and understanding, Process knowledge and understanding, Regulatory requirements, and 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 g