USP1058分析儀器確認(rèn)中英文對(duì)照

1、 ANALYTICAL INSTRUMENT QUALIFICATION分析儀器的確認(rèn)INTRODUCTION介紹A large variety of laboratory equipment, instruments, and computerized analytical systems, ranging from simple nitrogen evaporators to complex multiple-function technologies (see Instrument Categories), are used in the pharmaceutical industry

2、to acquire data to help ensure that products are suitable for their intended use. An analysts objective is to consistently obtain reliable and valid data suitable for the intended purpose. Depending on the applications, users validate their procedures, calibrate their instruments, and perform additi

3、onal instrument checks, such as system suitability tests and analysis of in-process quality control check samples to help ensure that the acquired data are reliable. With the increasing sophistication and automation of analytical instruments, an increasing demand has been placed on users to qualify

4、their instruments. 極其多種多樣的實(shí)驗(yàn)室設(shè)備、儀器、計(jì)算機(jī)分析系統(tǒng)，從簡單的氮吹儀到復(fù)雜的多功能技術(shù)（見儀器種類），被應(yīng)用于制藥工業(yè)，以取得數(shù)據(jù)來確保產(chǎn)品適合其預(yù)定用途。分析員的目標(biāo)是持續(xù)地獲得適合其意圖的可靠和有效的數(shù)據(jù)。取決于具體的應(yīng)用，使用者驗(yàn)證其方法、校準(zhǔn)其儀器，并進(jìn)行額外的儀器檢查，例如系統(tǒng)適用性測(cè)試和中間質(zhì)量控制檢查樣品的分析，以便幫助確保所獲得的數(shù)據(jù)是可靠的。隨著分析儀器的復(fù)雜性和自動(dòng)化程度不斷增加，使用者已經(jīng)感受到了不斷增加的確認(rèn)其儀器的要求。Unlike method validation and system suitability activities,

5、 analytical instrument qualification (AIQ) currently has no specific guidance or procedures. Competing opinions exist regarding instrument qualification and validation procedures and the roles and responsibilities of those who perform them. Consequently, various approaches have been used for instrum

6、ent qualification, approaches that require varying amounts of resources and generate widely differing amount of documentation. This chapter provides a scientific approach to AIQ and considers AIQ as one of the major components required for generating reliable and consistent data. Note that the amoun

7、t of rigor applied to the qualification process will depend on the complexity and intended use of the instrumentation. This approach emphasizes AIQs place in the overall process of obtaining the reliable data from analytical instruments. 不同于驗(yàn)證和系統(tǒng)適用性工作，分析儀器的確認(rèn)（AIQ）目前尚沒有具體的指導(dǎo)方針或程序。關(guān)于儀器確認(rèn)和驗(yàn)證程序，以及這些程序的執(zhí)

8、行者的角色和職責(zé)，存在著相互沖突的多種觀點(diǎn)。由此導(dǎo)致，多種方法已經(jīng)應(yīng)用于儀器確認(rèn)，而這些方法要求使用的資源數(shù)量各異并產(chǎn)生數(shù)量差距很大的文檔。此通則為AIQ提供了科學(xué)的方法，并將AIQ視為產(chǎn)生可靠和一致的數(shù)據(jù)所必需的主要組成部分之一。注意，應(yīng)用到確認(rèn)過程的嚴(yán)格程度將由該儀器的復(fù)雜性和預(yù)定用途來決定。這個(gè)方法強(qiáng)調(diào)了AIQ在從分析儀器中獲得可靠數(shù)據(jù)的全過程中的位置。Validation versus Qualification驗(yàn)證對(duì)確認(rèn)In this chapter, the term validation is used for manufacturing processes, analytica

9、l procedures, and software procedures and the term qualification is used for instruments. Thus, the phrase “analytical instrument qualification” (AIQ) is used for the process of ensuring that an instrument is suitable for its intended application. 在此通則中，驗(yàn)證一詞用于生產(chǎn)工藝、分析方法、軟件程序，而確認(rèn)一詞用于儀器。因此，“分析儀器的確認(rèn)”（AI

10、Q）一詞用于確保儀器適用于其預(yù)定用途的過程。COMPONENTS OF DATA QUALITY數(shù)據(jù)質(zhì)量的組成部分There are four critical components involved in the generation of reliable and consistent data (quality data). Figure 1 shows these components as layered activities within a quality triangle. Each layer adds to the overall quality. Analytical i

11、nstrument qualification forms the base for generating quality data. The other components essential for generating quality data are analytical method validation, system suitability tests, and quality control checks samples. These quality components are described as below.在產(chǎn)生可靠和一致的數(shù)據(jù)（質(zhì)量數(shù)據(jù)）的過程中涉及了四個(gè)重要的

12、組成部分。圖1以層疊形式在質(zhì)量三角形內(nèi)展示了這些組成部分。每層相加構(gòu)成了總體質(zhì)量。分析儀器確認(rèn)構(gòu)成了產(chǎn)生質(zhì)量數(shù)據(jù)的基礎(chǔ)。作為質(zhì)量數(shù)據(jù)產(chǎn)生的基礎(chǔ)的其他組成部分為分析方法驗(yàn)證、系統(tǒng)適用性測(cè)試、質(zhì)量控制檢驗(yàn)樣品。這些質(zhì)量部分描述如下。Quality Control Check SamplesSystem Suitability TestsAnalytical Method ValidationAnalytical Instrument QualificationFigure 1. Components of data qualityAnalytical Instrument Qualificatio

13、n分析儀器確認(rèn)AIQ is the collection of documented evidence that an instrument performs suitably for its intended purpose. Use of a qualified instrument in analyses contributes to confidence in the validity of generated data. AIQ是證明某個(gè)儀器表現(xiàn)得適合其預(yù)定用途的文件證據(jù)的匯總。在分析中使用確認(rèn)過的儀器確保了對(duì)所生成數(shù)據(jù)的有效性的信心。Analytical Method Valida

14、tion分析方法驗(yàn)證Analytical method validation is the collection of documented evidence that an analytical procedure is suitable for its intended use. Use of a validated procedure with qualified analytical instruments provides confidence that the procedure will generate test data of acceptable quality. Addi

15、tional guidance on validation of compendial procedures may be found in the general information chapter Validation of Compendial Procedures . 分析方法驗(yàn)證是某個(gè)分析方法適合其預(yù)定用途的文件證據(jù)的匯總。使用確認(rèn)過的分析儀器和驗(yàn)證過的方法確保了該方法將會(huì)產(chǎn)生質(zhì)量可接受的測(cè)試數(shù)據(jù)的信心。關(guān)于藥典方法的驗(yàn)證方法的額外指導(dǎo)原則可以在通則藥典方法的驗(yàn)證中找到。System Suitability Tests系統(tǒng)適用性測(cè)試System suitability tests

16、 verify that the system will perform in accordance with the criteria set forth in the procedure. These tests are performed along with the sample analyses to ensure that the systems performance is acceptable at the time of the test. USP general chapter Chromatography presents a more detailed discussi

17、on of system suitability tests as related to chromatographic systems. 系統(tǒng)適用性測(cè)試證實(shí)該系統(tǒng)的表現(xiàn)將會(huì)符合此方法中設(shè)定的標(biāo)準(zhǔn)。這些測(cè)試與樣品分析儀器進(jìn)行，從而確保此系統(tǒng)的表現(xiàn)在測(cè)試的時(shí)候是可以接受的。USP通則色譜法呈現(xiàn)了對(duì)于色譜系統(tǒng)的系統(tǒng)適用性測(cè)試的更加具體討論。Quality Control Check Samples質(zhì)量控制檢驗(yàn)樣品Many analysts carry out their tests on instruments standardized using reference materials and/

18、or calibration standards. Some analysts also require the inclusion of quality control check samples to provide an in-process or ongoing assurance of the tests suitable performance. In this manner, AIQ and analytical method validation contribute to the quality of analysis before analysts conduct the

19、tests. System suitability tests and quality control checks help ensure the quality of analytical results immediately before or during sample analysis. 許多分析員在以標(biāo)準(zhǔn)物質(zhì)和/或校準(zhǔn)標(biāo)準(zhǔn)品進(jìn)行標(biāo)準(zhǔn)化的儀器上進(jìn)行他們的測(cè)試。一些分析員還要求加入質(zhì)量控制檢驗(yàn)樣品，以便對(duì)此測(cè)試的適當(dāng)表現(xiàn)提供中間或持續(xù)的保證。在這個(gè)方面，在分析員進(jìn)行該測(cè)試之前，AIQ和分析方法驗(yàn)證就對(duì)分析質(zhì)量起到了作用。系統(tǒng)適用性測(cè)試和質(zhì)量控制檢查，則在樣品分析馬上開始之前或在其過程

20、中，幫助確保分析結(jié)果的質(zhì)量。ANALYTICAL INSTRUMENT QUALIFICATION PROCESS分析儀器確認(rèn)程序The following sections address in detail the AIQ process. The other three components of building quality into analytical data - analytical method validation, system suitability tests, and quality control check samples - are not within

21、the scope of this chapter. 下面的章節(jié)具體解答了AIQ的過程。確保分析數(shù)據(jù)質(zhì)量的其他3個(gè)組成部分，分析方法驗(yàn)證、系統(tǒng)適用性測(cè)試、質(zhì)量控制檢驗(yàn)樣品，不在此通則的范圍之內(nèi)。Qualification Phases確認(rèn)的階段Instrument qualification is not a single continuous process, but instead results from several discrete activities. For convenience, these activities can be grouped into four phas

22、es: design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).儀器確認(rèn)不是一個(gè)單獨(dú)的連續(xù)過程，而是源自若干獨(dú)立活動(dòng)的結(jié)果。為方便起見，這些活動(dòng)可以被歸為4個(gè)階段：設(shè)計(jì)確認(rèn)（DQ）、安裝確認(rèn)（IQ）、運(yùn)行確認(rèn)（OQ）、性能確認(rèn)（PQ）。Some AIQ activities cover more than one qualification phase, and analysts potential

23、ly could perform them during more than one of the phases (see Table 1). However, in many instances there is need for specific order to the AIQ activities; for example, installation qualification must occur first in order to initiate other qualification activities. The AIQ activities will be defined

24、and documented. 一些AIQ活動(dòng)包括了超過一個(gè)確認(rèn)階段，并且分析員傾向于可以跨階段進(jìn)行這些活動(dòng)（見表1）。但是，在很多情況下，AIQ活動(dòng)有特定的順序要求；例如，安裝確認(rèn)必須首先發(fā)生，以便啟動(dòng)其他確認(rèn)活動(dòng)。AIQ活動(dòng)將被定義并以文件形式記錄。Table 1. Timing, Applicability, and Activities for Each Phase of Analytical Instrument Qualification* Design QualificationInstallation QualificationOperational Qualification

25、Performance QualificationTiming and ApplicabilityPrior to purchase of a new model of instrumentAt installation of each instrument (new, old, or existing unqualified)After installation or major repair of each instrumentPeriodically at specified intervals for each instrumentActivitiesAssurance of manu

26、facturers DQDescriptionFixed parametersPreventive maintenance and repairsAssurance of adequate support availability from manufacturerInstrument deliveryEstablish practices to address operation, calibration, maintenance, and change controlInstruments fitness for use in laboratoryUtilities/facilityEnv

27、ironmentAssembly and installationNetwork and data storageSecure data storage, backup, and archiveInstallation verificationInstrument function testsPerformance checks*Activities under each phase are usually performed as given in the table. However, in some cases, it may be more appropriate to perform

28、 or combine a given activity with another phase. Such activities, spanning more than one qualification phase are shown as connected by double arrows. If an activity listed under a given phase is performed under another phase, it is not necessary to repeat the activity under the phase where the activ

29、ity is listed. Performing the activity is far more important than the phase under which the activity is performed.表1. 分析儀器確認(rèn)每個(gè)階段的時(shí)間表、實(shí)用性、活動(dòng)設(shè)計(jì)確認(rèn)安裝確認(rèn)運(yùn)行確認(rèn)性能確認(rèn)時(shí)間表和實(shí)用性在購買新型儀器之前在安裝每個(gè)儀器時(shí)(新的、舊的、或一直未經(jīng)確認(rèn)的)在每個(gè)儀器安裝或大修之后每個(gè)儀器在規(guī)定的間隔定期進(jìn)行活動(dòng)確認(rèn)制造商設(shè)計(jì)確認(rèn)描述固定參數(shù)預(yù)防性保養(yǎng)和維修確認(rèn)制造商可以給與充分支持儀器運(yùn)送設(shè)立相關(guān)規(guī)程，以解決操作、校準(zhǔn)、維護(hù)、變更控制儀器在實(shí)驗(yàn)室中使用的適用性公

30、用設(shè)施/設(shè)施環(huán)境組裝與安裝網(wǎng)絡(luò)和數(shù)據(jù)儲(chǔ)存安全的數(shù)據(jù)儲(chǔ)存、備份、存檔安裝確認(rèn)儀器功能測(cè)試性能測(cè)試在每個(gè)階段下的活動(dòng)通常按照表中列出地進(jìn)行。但是，在某些情況下，可以更加適合進(jìn)行或合并某個(gè)特定活動(dòng)于其他階段。這樣跨域超過一個(gè)確認(rèn)階段的活動(dòng)用雙箭頭連接來顯示。如果某個(gè)列出于特定階段的活動(dòng)進(jìn)行于另外一個(gè)階段，沒有必要在列出該活動(dòng)的階段重復(fù)進(jìn)行。進(jìn)行該活動(dòng)要比該活動(dòng)在那個(gè)階段進(jìn)行重要許多。DESIGN QUALIFICATION設(shè)計(jì)確認(rèn)Design qualification (DQ) is the documented collection of activities that define the f

31、unctional and operational specifications of the instrument and criteria for the selection of the vendor, based on the intended purpose of the instrument. Design qualification (DQ) may be performed not only by the instrument developer or manufacturer but also may be performed by the user. The manufac

32、turer is generally responsible for robust design and maintaining information describing how the analytical instrument is manufactured (design specifications, functional requirements, etc.) and tested before shipment to users. Nonetheless, the user should ensure that commercial off-the-shelf (COTS) i

33、nstrument are suitable for their intended application and that the manufacturer has adopted a quality system that provides for reliable equipment. Users should also determine the manufacturers capability for support installation, services, and training. This determination might be aided by the users

34、 previous interaction with the manufacturer. 設(shè)計(jì)確認(rèn)（DQ）是基于儀器預(yù)定用途，對(duì)儀器的功能與操作標(biāo)準(zhǔn)和提供商的選取標(biāo)準(zhǔn)做出規(guī)定的活動(dòng)總匯，并以文件記錄。設(shè)計(jì)確認(rèn)（DQ）不僅可以由儀器開發(fā)者或制造商進(jìn)行，也可以有使用者進(jìn)行。制造商通常負(fù)責(zé)穩(wěn)健設(shè)計(jì)和維護(hù)信息，描述該分析儀器如何制造（設(shè)計(jì)標(biāo)準(zhǔn)、功能要求等）在發(fā)給客戶之前如何測(cè)試。雖然如此，使用者仍應(yīng)該確保商用成品儀器適用于他們的預(yù)定用途，并且制造商已經(jīng)采納了能夠保證儀器可靠的質(zhì)量系統(tǒng)。使用者也應(yīng)該確定制造商在輔助安裝、服務(wù)、培訓(xùn)方面的能力。確定的過程可以借助使用者以前與制造商的互動(dòng)交流。INSTALL

35、ATION QUALIFICATION安裝確認(rèn)Installation qualification (IQ) is the documented collection of activities necessary to establish that an instrument is delivered as designed and specified, and is properly installed in the selected environment, and that this environment is suitable for the instrument. IQ appl

36、ies to an instrument that is new or was pre-owned, or to any instrument that exists on site but has not been previous qualified. Relevant parts of IQ would also apply to a qualified instrument that has been transported to another location or is being reinstalled for other reasons, such as prolonged

37、storage. The activities and documentation typically associated with IQ are as follows. 安裝確認(rèn)（IQ）是對(duì)用于確定某個(gè)儀器按照設(shè)計(jì)和規(guī)定的方式運(yùn)輸并正確安裝在選定的環(huán)境中，以及該環(huán)境適合于此儀器所必需的活動(dòng)總匯，并以文件記錄。IQ應(yīng)用于某件儀器，其可以是新的或是二手的，或應(yīng)用于任何已經(jīng)在現(xiàn)場(chǎng)但是此前從未確認(rèn)過的儀器。IQ的相關(guān)部分也會(huì)用于某個(gè)已經(jīng)確認(rèn)的設(shè)備，但是該設(shè)備經(jīng)過運(yùn)輸至另外的一個(gè)場(chǎng)所或由于其他原因（例如，延長的存儲(chǔ)）重新安裝。通常與IQ相關(guān)的活動(dòng)和文件如下。Description- Provide

38、a description of the instrument or the collection of instrument components, including its manufacturer, model, serial number, software version, and location. Use of drawings and flow chart where appropriate. 描述-提供該儀器或者儀器組成部分匯總的描述，包括其制造商、型號(hào)、編號(hào)、軟件版本、放置位置。適當(dāng)情況下使用圖紙和流程圖。Instrument Delivery- Ensure that

39、the instrument, software, manuals, supplies, and any other instrument accessories arrive as specified in the purchase order and that they are undamaged. For a pre-owned or existing instrument, manuals and documentation should be obtained. 儀器運(yùn)輸- 確保該儀器、軟件、手冊(cè)、供給品，以及其他儀器附件按照訂單中規(guī)定的方式抵達(dá)，并且他們沒有損壞。對(duì)于二手或已有的儀

40、器，手冊(cè)和記錄文件必須得到。Utilities/Facility/Environment-Verify that the installation site satisfactorily meets manufacturer-specified environmental requirements. 公用設(shè)施/設(shè)施/環(huán)境-證實(shí)安裝區(qū)域令人滿意地達(dá)到了制造商規(guī)定的環(huán)境要求。Assembly and installation- Assembly and install the instrument, and perform any preliminary diagnostics and testi

41、ng. Assembly and installation may be done by the manufacturer, vendor, specialized engineers, or qualified in-house personnel. Manufacturer-established installation tests and guides provide a valuable baseline reference for determining instrument acceptance. Any abnormal event observed during assemb

42、ly and installation merits documenting. Installation packages purchased from the manufacturer or the vendor may, however, need to be supplemented with user-specific criteria. 組裝和安裝- 組裝和安裝儀器，并進(jìn)行任何預(yù)診斷和測(cè)試。組裝和安裝可以由其制造商、供應(yīng)商、專業(yè)工程師、或有資質(zhì)的內(nèi)部員工來進(jìn)行。對(duì)于確定儀器的驗(yàn)收，制造商確定的安裝測(cè)試和指導(dǎo)提供了具有價(jià)值的基本參考。在組裝和安裝過程中觀察到的任何異常事件均需以文件記錄

43、。但是，購自制造商或供應(yīng)商的安裝包需要根據(jù)用戶的具體標(biāo)準(zhǔn)進(jìn)行補(bǔ)充。Network and Data Storage- Some analytical systems require users to provide network connections and data storage capabilities at the installation site. When required, connect the instrument to the network, and check its functionality. 網(wǎng)絡(luò)和數(shù)據(jù)儲(chǔ)存- 一些分析系統(tǒng)要求使用者在安裝場(chǎng)所提供網(wǎng)絡(luò)連接和數(shù)

44、據(jù)存儲(chǔ)能力。當(dāng)需要時(shí)，將儀器連接到網(wǎng)絡(luò)，并檢查其功能。Installation Verification- Perform the initial diagnostics and testing of the instrument after installation. 安裝認(rèn)證- 在安裝之后，進(jìn)行該儀器的初始診斷和測(cè)試。OPERATIONAL QUALIFICATION運(yùn)行確認(rèn)After a successful IQ, the instrument is ready for OQ testing. Operational qualification (OQ) is the document

45、ed collection of activities necessary to demonstrate that an instrument will function according to its operational specification in the selected environment. Testing activities in the OQ phase consist of these test parameters. 在成功的IQ之后，此儀器就可以進(jìn)行OQ測(cè)試了。操作確認(rèn)（OQ）是證實(shí)某個(gè)儀器將會(huì)在選定的環(huán)境中按照其操作規(guī)范運(yùn)行所必需的活動(dòng)總匯，并以文件記錄。在

46、OQ階段的測(cè)試活動(dòng)包含了這些測(cè)試參數(shù)。Fixed Parameter- These tests measure the instruments non-changing parameter such as length, height, weight, voltage inputs, acceptable pressures, and loads. If the manufacturer-supplied specifications for these parameters satisfy the user, the test requirements may be waived. Howe

47、ver, if the user wants to confirm the parameters, testing can be performed at the users site. Fixed parameters do not change over the life of the instrument, and therefore never need redetermination. NOTE: These tests could also be performed during the IQ phase (see Table 1); if so, fixed parameters

48、 need not be redetermined as part of OQ testing.固定參數(shù)- 這些測(cè)試測(cè)量該儀器的不變參數(shù)，例如長度、高度、重量、輸入電壓、可接受壓力、載荷等。如果由制造商提供的這些參數(shù)的規(guī)格令用戶滿意，可以放棄測(cè)試要求。但是，如果用戶需要確認(rèn)這些參數(shù)，可以在使用者的場(chǎng)地進(jìn)行測(cè)試。固定參數(shù)在儀器的壽命周期內(nèi)不會(huì)變化，并且因此不需重測(cè)?！咀⒁猓哼@些測(cè)試還可以在IQ階段（見表1）進(jìn)行；如果這樣，固定參數(shù)作為OQ測(cè)試的一部分，無需重測(cè)。】Secure Data Storage, Backup, and Archiving- When applicable, test s

49、ecure data handling such as storage, backup, audit trails, and archiving at the users site according to written procedures. 安全數(shù)據(jù)存儲(chǔ)、備份、存檔- 當(dāng)可行的時(shí)候，根據(jù)書面程序，在用戶的場(chǎng)所測(cè)試安全數(shù)據(jù)處理工作，例如存儲(chǔ)、備份、審計(jì)追蹤、存檔等。Instrument Function Tests- Instrument functions required by the user should be tested to verify that the instrumen

50、t operates as intended by the manufacturer. Manufacturer-supplied information is useful in identifying specifications for these parameters and in designing tests to evaluate the identified parameters. Users, or their qualified designees, should perform these tests to verify that the instrument meets

51、 manufacturer or user specifications in the users environment. 儀器功能測(cè)試- 使用者要求的儀器功能應(yīng)該被測(cè)試，以確認(rèn)該儀器能夠按照制造商所預(yù)期地操作。制造商提供的信息有助于識(shí)別這些參數(shù)的規(guī)范，并幫助設(shè)計(jì)用于評(píng)估這些識(shí)別出來的參數(shù)的測(cè)試。使用者，或者他們的有資質(zhì)的設(shè)計(jì)師，應(yīng)該進(jìn)行這些測(cè)試，以便證實(shí)該儀器在使用者的環(huán)境中達(dá)到了制造商或使用者的標(biāo)準(zhǔn)。The extent of OQ testing that an instrument undergoes depends on its intended applications. The

52、refore, no specific OQ tests for any instrument or application are offered in this chapter. 某個(gè)儀器經(jīng)歷的OQ測(cè)試的程度取決于其預(yù)定用途。因此，在此通則中沒有為任何儀器或用途提供任何具體的OQ測(cè)試。Routine analytical tests do not constitute OQ testing. OQ tests are specifically designed to verify the instruments operation according to specifications i

53、n the users environment, and repeating the testing at regular intervals may not be required. However, when the instrument undergoes major repairs or modifications, relevant OQ and/or PQ tests should be repeated to verify whether the instrument continues to operate satisfactorily. If an instrument is

54、 moved to another location, an assessment should be made of what, if any, OQ test should be repeated. 日常分析檢測(cè)不構(gòu)成OQ測(cè)試。OQ測(cè)試是特別設(shè)計(jì)，用于確認(rèn)在用戶環(huán)境中該儀器根據(jù)其規(guī)范的運(yùn)行情況，并且定且重復(fù)該測(cè)試可能沒有必要。但是，當(dāng)儀器經(jīng)歷大修或改裝時(shí)，相關(guān)的OQ和/或PQ測(cè)試應(yīng)該重復(fù)，以便確認(rèn)該儀器是否繼續(xù)令人滿意地運(yùn)轉(zhuǎn)。如果某個(gè)儀器移到另一個(gè)位置，應(yīng)該進(jìn)行一項(xiàng)評(píng)估，以確定什么OQ測(cè)試應(yīng)該被重復(fù)（如果確實(shí)有的話）。OQ tests can be modular or holistic.

55、 Modular testing of individual components of a system may facilitate interchanging of such components without requalification. Holistic tests, when involve the entire system, are also acceptable. OQ測(cè)試可以為模塊式或整體式。系統(tǒng)中的單個(gè)組成部分的模塊式測(cè)試可以方便這樣的組成部分的交換，而無需重新確認(rèn)。設(shè)計(jì)整個(gè)系統(tǒng)的整體式測(cè)試也是可以接受的。PERFORMANCE QUALIFICATION性能確認(rèn)P

56、erformance qualification (PQ) is the documented collection of activities necessary to demonstrate that an instrument consistently performs according to the specifications defined by the user, and is appropriate for the intended use. After IQ and OQ have been performed, the instruments continued suit

57、ability for its intended use is demonstrated through performance qualification. The PQ phase may include the following parameters. 性能確認(rèn)（PQ）是證實(shí)某個(gè)儀器持續(xù)地按照由用戶定義的規(guī)范運(yùn)行，并適合其預(yù)定用途的活動(dòng)總匯，并以文件記錄。在IQ和OQ已經(jīng)執(zhí)行之后，該儀器對(duì)其預(yù)定用途的持續(xù)適用性通過性能確認(rèn)來證實(shí)。此PQ階段可以包括下列參數(shù)。Performance Checks- Set up a test or series of tests to verify the acceptable performance of the instrument for its intended use. PQ tests are usually based on the instruments typical on-site applications and may consist of analyzing known components or standards. The tests should be based on good science and reflect the general intended use of the instrum