USP-1058 分析儀器確認(rèn)（AIQ）【中英對(duì)照】

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1、<1058>ANALYTICAL INSTRUMENT QUALIFICATION 分析儀器的確認(rèn) (USP39-NF34 Page1055) 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 u

2、sed in the pharmaceutical industry 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 th

3、eir instruments, and perform additional 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 h

4、as been placed on users to qualify their instruments. 各種各樣的實(shí)驗(yàn)室設(shè)備、儀器、計(jì)算機(jī)化分析系統(tǒng)，從簡(jiǎn)單的氮吹儀到復(fù)雜的多功能技術(shù)（見(jiàn)Instrument Categories），均被用于制藥行業(yè)，以獲得數(shù)據(jù)來(lái)確保產(chǎn)品達(dá)到預(yù)期用途。分析的目的是持續(xù)獲得符合預(yù)期目的的可靠的有效數(shù)據(jù)?；趯?shí)際應(yīng)用，使用者進(jìn)行工藝驗(yàn)證、儀器校準(zhǔn)，并進(jìn)行額外的儀器檢核，如系統(tǒng)適用性試驗(yàn)和中間質(zhì)量控制分析檢查樣品，以確保所獲得數(shù)據(jù)的可靠性。隨著分析儀器的日益復(fù)雜化和自動(dòng)化，對(duì)儀器確認(rèn)的要求也在不斷增加。 Unlike method validation and

5、 system suitability activities, 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 approa

6、ches have been used for instrument qualification, approaches that require varying amounts of resources and generate widely differing amounts of documentation. This chapter provides a scientific approach to AIQ and considers AIQ as one of the major components required for generating reliable and cons

7、istent data. Note that the amount 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 reliable data from analytical instruments. 不同于方法學(xué)驗(yàn)證和系統(tǒng)適用性試驗(yàn)，分析儀器確認(rèn)（AIQ）目前并沒(méi)有

8、明確的指導(dǎo)和規(guī)程。關(guān)于儀器確認(rèn)和驗(yàn)證程序，以及執(zhí)行它們的角色和職責(zé)，存在著互相矛盾的觀(guān)點(diǎn)。由此導(dǎo)致，已有多種方法應(yīng)用于儀器確認(rèn)，而這些方法需要使用的資源數(shù)量各異并產(chǎn)生數(shù)量差異巨大的文件。本節(jié)為分析儀器確認(rèn)（AIQ）提供了科學(xué)的方法，并將分析儀器確認(rèn)（AIQ）作為產(chǎn)生可靠性和一致性數(shù)據(jù)的重要組成部分。注意，精確應(yīng)用于確認(rèn)工序的程度取決于儀器的復(fù)雜程度和預(yù)期用途。這種方法強(qiáng)調(diào)了AIQ從分析儀器中獲得可靠數(shù)據(jù)的全過(guò)程中的地位。 Validation versus Qualification 驗(yàn)證vs確認(rèn) In this chapter, the term validation is used f

9、or manufacturing processes, analytical 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. 在本節(jié)中，驗(yàn)證一詞用于生產(chǎn)工

10、藝、分析方法及軟件程序中，而確認(rèn)一詞則用于儀器。因此，“分析儀器的確認(rèn)”（AIQ）用于確保儀器適用于預(yù)期用途的過(guò)程。 COMPONENTS OF DATA QUALITY 數(shù)據(jù)質(zhì)量的組成 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 ad

11、ds to the overall quality. Analytical instrument 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 check samples. These quality components are described

12、below. 組成可靠和一致數(shù)據(jù)（質(zhì)量數(shù)據(jù)）的有四個(gè)關(guān)鍵部分。圖1將這些部分展示在質(zhì)量三角形的層級(jí)區(qū)域內(nèi)。每層相加構(gòu)成了整體質(zhì)量。分析儀器的確認(rèn)是產(chǎn)生質(zhì)量數(shù)據(jù)的基礎(chǔ)。構(gòu)成質(zhì)量數(shù)據(jù)的其他部分為分析方法驗(yàn)證、系統(tǒng)適用性試驗(yàn)和質(zhì)量控制檢驗(yàn)樣品。這些質(zhì)量部分詳情如下。 Figure 1. Components of data quality. 圖1.質(zhì)量數(shù)據(jù)的組成 Analytical Instrument Qualification 分析儀器的確認(rèn) AIQ is the collection of documented evidence that an instrument perf

13、orms suitably for its intended purpose. Use of a qualified instrument in analyses contributes to confidence in the validity of generated data. AIQ匯總了為確定儀器符合預(yù)期用途的文件證明。使用合格的分析儀器能提高生成數(shù)據(jù)的有效性。 Analytical Method Validation 分析方法驗(yàn)證 Analytical method validation is the collection of documented evidence tha

14、t 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. Additional guidance on validation of compendial procedures may be found in the general

15、information chapter Validation of Compendial Procedures <1225> . 分析方法驗(yàn)證匯總了分析過(guò)程適用于預(yù)期用途的文件證明。使用經(jīng)確認(rèn)的分析儀器和驗(yàn)證過(guò)的方法所產(chǎn)生的測(cè)試數(shù)據(jù)才可能符合規(guī)定。關(guān)于藥典中驗(yàn)證方法的額外指導(dǎo)可參見(jiàn)通則<1225>藥典方法的驗(yàn)證。 System Suitability Tests 系統(tǒng)適用性試驗(yàn) System suitability tests verify that the system will perform in accordance with the criteria set forth in

16、 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 <621> presents a more detailed discussion of system suitability tests as related to chromatographic systems. 系統(tǒng)適用

17、性試驗(yàn)用于證實(shí)該系統(tǒng)符合方法中設(shè)定的標(biāo)準(zhǔn)。這些試驗(yàn)連同樣品分析一起，確保系統(tǒng)的性能在測(cè)試時(shí)是適用的。USP通則<621>色譜法呈現(xiàn)了對(duì)色譜系統(tǒng)適用性試驗(yàn)更詳細(xì)的討論。 Quality Control Check Samples 質(zhì)量控制檢查樣品 Many analysts carry out their tests on instruments standardized using reference materials and/or calibration standards. Some analyses also require the inclusion of quality con

18、trol 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 tests. System suitability tests and quality control checks help ensure the qualit

19、y of analytical results immediately before or during sample analysis. 許多分析員用經(jīng)標(biāo)準(zhǔn)物質(zhì)和/或校準(zhǔn)標(biāo)準(zhǔn)品校準(zhǔn)后的儀器進(jìn)行測(cè)試。有些分析員還要求添加質(zhì)量控制檢查樣品來(lái)保證試驗(yàn)過(guò)程中或持續(xù)的試驗(yàn)適用性。通過(guò)這種方式，AIQ和分析方法驗(yàn)證在測(cè)試前提高了分析的質(zhì)量。系統(tǒng)適用性試驗(yàn)和質(zhì)量控制檢查則在樣品分析前或過(guò)程中確保了分析結(jié)果的質(zhì)量 ANALYTICAL INSTRUMENT QUALIFICATION PROCESS 分析儀器確認(rèn)程序 The following sections address in detai

20、l 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 the scope of this chapter. 下面將詳述AIQ過(guò)程。組成分析數(shù)據(jù)質(zhì)量的另三種成分，分析方法驗(yàn)證、系統(tǒng)適用性試驗(yàn)、質(zhì)量控制檢查樣品，不在此范圍內(nèi)。 Qualification Phases

21、確認(rèn)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 phases: design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qual

22、ification (PQ). 儀器確認(rèn)并非一個(gè)單獨(dú)連續(xù)的過(guò)程，而是若干個(gè)獨(dú)立處理的結(jié)果。方便起見(jiàn)，這些處理可分為四個(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 potentially could perform them during more than one of the phases (see Table 1). However, in many instances there is need for

23、 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 and documented. 一些AIQ涵蓋多個(gè)確認(rèn)階段，分析員傾向于進(jìn)行多個(gè)階段的確認(rèn)（見(jiàn)表1）。然而，在很多情況下，AIQ有特定順序要求；比如，必須先進(jìn)行安裝確認(rèn)才能開(kāi)始實(shí)施其它確認(rèn)。AIQ將被定義并以文件形式記錄。 T

24、able 1. Timing, Applicability, and Activities for Each Phase of Analytical Instrument Qualification* 表1.分析儀器確認(rèn)每一階段的時(shí)間表、適用性和活動(dòng) Design Qualification 設(shè)計(jì)確認(rèn) Installation Qualification 安裝確認(rèn) Operational Qualification 運(yùn)行確認(rèn) Performance Qualification 性能確認(rèn) Timing and Applicability時(shí)間表和適用性 Prior t

25、o purchase of a new model of instrument 購(gòu)買(mǎi)儀器之前 At installation of each instrument (new, old, or existing unqualified) 安裝儀器時(shí)（新的、舊的或一直未經(jīng)確認(rèn)的） After installation or major repair of each instrument 安裝完成后或大修之后 Periodically at specified intervals for each instrument 儀器在規(guī)定間隔內(nèi)定期進(jìn)行 Activities活動(dòng) A

26、ssurance of manufacturers DQ 保證制造商設(shè)計(jì)確認(rèn) Description 描述 Fixed parameters 固定參數(shù) Preventive maintenance and repairs 預(yù)防性維護(hù) Assurance of adequate support availability from manufacturer 保證制造商給予充分支持 Instrument delivery 儀器運(yùn)送 Establish practices to address operation, calibration, maintena

27、nce, and change control 建立相關(guān)規(guī)程用以處理操作、校準(zhǔn)、維護(hù)及變更控制 Instruments fitness for use in laboratory 儀器在實(shí)驗(yàn)室使用的適用性 Utilities/facility 公用設(shè)施/設(shè)備 Environment環(huán)境 Assembly and installation組裝與安裝 Network and data storage 網(wǎng)絡(luò)和數(shù)據(jù)儲(chǔ)存 Secure data storage, backup, and archive 安全數(shù)據(jù)儲(chǔ)存、備份與存檔 Install

28、ation verification 安裝確認(rèn) Instrument function tests儀器性能測(cè)試 Performance checks 性能檢查 * Activities under each phase are usually performed as given in the table. However, in some cases, it may be more appropriate to perform or combine a given activity with another phase. Such activities spanning m

29、ore 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 activity is listed. Performing the activity is far more important than the phase

30、under which the activity is performed. * 每個(gè)階段的活動(dòng)通常按表中所列進(jìn)行。但在某些情況下，某個(gè)活動(dòng)可能更適合采用另一階段或者與之結(jié)合來(lái)進(jìn)行確認(rèn)。這些活動(dòng)橫跨不只一個(gè)階段，如表中雙箭頭所示。如果某個(gè)列于給定階段下的活動(dòng)在另一階段中完成，那么就沒(méi)有必要在列出該活動(dòng)的階段重復(fù)進(jìn)行。完成該項(xiàng)活動(dòng)比該活動(dòng)處于哪個(gè)階段重要得多。 DESIGN QUALIFICATION 設(shè)計(jì)確認(rèn) Design qualification (DQ) is the documented collection of activities that define the funct

31、ional and operational specifications of the instrument and criteria for 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 manufacturer is

32、 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) instrumen

33、ts 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 previo

34、us interaction with the manufacturer. 設(shè)計(jì)確認(rèn)（DQ）是基于儀器的預(yù)定用途，對(duì)儀器的功能與操作規(guī)程和供應(yīng)商的選擇標(biāo)準(zhǔn)作出規(guī)定，并以文件記錄。設(shè)計(jì)確認(rèn)（DQ）不僅可以由儀器開(kāi)發(fā)者和制造商進(jìn)行，也可由使用者進(jìn)行。制造商通常負(fù)責(zé)穩(wěn)健設(shè)計(jì)和維護(hù)信息—描述分析儀器如何制造（設(shè)計(jì)規(guī)范、功能要求等），及發(fā)貨前的測(cè)試。盡管如此，使用者仍應(yīng)確保商用成品儀器適用于其預(yù)期用途，并且制造商已經(jīng)采納了能提供可靠?jī)x器的質(zhì)量系統(tǒng)。使用者還應(yīng)確定制造商有支持安裝、服務(wù)、培訓(xùn)的能力。這個(gè)決定可以借助使用者之前與制造商之間的交流完成。 INSTALLATION QUALIFICATION

35、 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 applies to an instru

36、ment that is new or was pre-owned, or to any instrument that exists on site but has not been previously 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 storage. The a

37、ctivities and documentation typically associated with IQ are as follows. 安裝確認(rèn)（IQ）是用于確定儀器是否按照設(shè)計(jì)和指定的方式運(yùn)輸并正確安裝在選定的環(huán)境中，以及該環(huán)境對(duì)此儀器的適用性，并以文件記錄。IQ可用于新的或二手的儀器，也可用于已在現(xiàn)場(chǎng)但未經(jīng)確認(rèn)過(guò)的儀器。IQ的相關(guān)部分也可用于某個(gè)已經(jīng)確認(rèn)但又運(yùn)送至另一場(chǎng)所的儀器，或因其他原因（如長(zhǎng)期儲(chǔ)存）需重新安裝的儀器。相關(guān)的典型活動(dòng)和文件如下： Description— Provide a description of the instrument or the coll

38、ection of instrument components, including its manufacturer, model, serial number, software version, and location. Use drawings and flow charts where appropriate. 描述—提供該儀器或儀器組成部分的描述，包括其制造商、型號(hào)、編號(hào)、軟件版本和位置。適當(dāng)情況下可使用圖紙和流程圖。 Instrument Delivery— Ensure that the instrument, software, manuals, supplies,

39、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—確保儀器、軟件、手冊(cè)、物料和其他儀器附件按照采購(gòu)單中規(guī)定的方式到達(dá)，并且未經(jīng)損壞。對(duì)于二手或已有儀器，需要獲得手冊(cè)和記錄文件。 Utilities/Facility/Environment— Ve

40、rify that the installation site satisfactorily meets manufacturer-specified environmental requirements. 公用設(shè)備/設(shè)施/環(huán)境—確認(rèn)安裝場(chǎng)所符合制造商規(guī)定環(huán)境的要求。 Assembly and Installation— Assemble and install the instrument, and perform any preliminary diagnostics and testing. Assembly and installation may be done by the

41、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 assembly and installation merits documenting. Installat

42、ion 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)行預(yù)診斷和測(cè)試。組裝和安裝可由制造商、供應(yīng)商、專(zhuān)業(yè)工程師或經(jīng)授權(quán)的內(nèi)部人員來(lái)進(jìn)行。制造商建立的儀器測(cè)試和指導(dǎo)為確定儀器的驗(yàn)收提供了有價(jià)值的基本參考。在組裝和安裝過(guò)程中任何異常事件均需記錄。但是，從制造商或供應(yīng)商處購(gòu)買(mǎi)的安裝包需要根據(jù)用戶(hù)的特定標(biāo)準(zhǔn)進(jìn)行增補(bǔ)。 Network and Data Storage—

43、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)保存—一些分析系統(tǒng)要求使用者在安裝場(chǎng)所提供聯(lián)網(wǎng)和數(shù)據(jù)儲(chǔ)存功能。需要時(shí)對(duì)儀器連網(wǎng)，并檢查其功能。 Installation Verification— Perform t

44、he initial diagnostics and testing of the instrument after installation. 安裝確認(rèn)—安裝后進(jìn)行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 documented collection of activities necessary to demonstrate that an

45、instrument will function according to its operational specification in the selected environment. Testing activities in the OQ phase may consist of these test parameters. IQ成功后，儀器即可進(jìn)行OQ確認(rèn)。運(yùn)行確認(rèn)（OQ）是證實(shí)儀器具有在選定環(huán)境中按照其操作規(guī)范運(yùn)行的功能。OQ階段的測(cè)試包含了這些測(cè)試參數(shù)。 Fixed Parameters— These tests measure the instruments nonch

46、anging parameters 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. However, if the user wants to confirm the parameters, testing can be performed at

47、 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 need not be redetermined as part of OQ testing. ] 固定參數(shù)—這些測(cè)試測(cè)量?jī)x器的不變參數(shù)，如長(zhǎng)度、

48、高度、重量、輸入電壓、可接受壓力和負(fù)荷。如果制造商提供的這些參數(shù)規(guī)格符合用戶(hù)要求，就可以免除測(cè)試。但用戶(hù)如果需要確認(rèn)這些參數(shù)，可以在用戶(hù)的場(chǎng)地進(jìn)行測(cè)試。固定參數(shù)在儀器壽命周期內(nèi)保持不變，因此無(wú)需重測(cè)。[注：這些測(cè)試也可在IQ階段進(jìn)行（見(jiàn)表1）；如此一來(lái)，固定參數(shù)就無(wú)需在OQ測(cè)試部分重測(cè)。] Secure Data Storage, Backup, and Archiving— When applicable, test secure data handling such as storage, backup, audit trails, and archiving at the users

49、site according to written procedures. 安全數(shù)據(jù)儲(chǔ)存、備份和歸檔—當(dāng)適用時(shí)，可根據(jù)書(shū)面程序在用戶(hù)場(chǎng)所進(jìn)行測(cè)試安全數(shù)據(jù)的處理，如保存、備份、審計(jì)追蹤和歸檔。 Instrument Function Tests— Instrument functions required by the user should be tested to verify that the instrument operates as intended by the manufacturer. Manufacturer-supplied information is useful

50、 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 manufacturer or user specifications in the users environment. 儀器功能測(cè)試—根據(jù)用戶(hù)需要對(duì)儀器功能進(jìn)行測(cè)試

51、，確認(rèn)儀器能夠按制造商的預(yù)期運(yùn)行。制造商提供的信息有助于識(shí)別這些參數(shù)的規(guī)格和設(shè)計(jì)被識(shí)別參數(shù)的評(píng)估測(cè)試。使用者或授權(quán)的指定人員應(yīng)進(jìn)行這些測(cè)試，以確定在使用環(huán)境中這些儀器滿(mǎn)足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. Therefore, no specific OQ tests for any instrument or application are offered in this chapter. 儀器OQ測(cè)試的范圍取決于其預(yù)

52、期的用途。因此，在此通則中沒(méi)有為任何儀器或用途提供具體的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 in the users environment, and repeating the testing at regular intervals may not be required. However, when the

53、 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 moved to another location, an assessment should be made of what, if any, OQ test should be repeated. 日常分析測(cè)試并

54、不包含OQ測(cè)試。OQ測(cè)試是特定設(shè)計(jì)的，用于確認(rèn)儀器在用戶(hù)環(huán)境中根據(jù)規(guī)程的運(yùn)行情況，并且無(wú)需重復(fù)測(cè)試。然而，當(dāng)儀器進(jìn)行大修或變動(dòng)時(shí)，相關(guān)的OQ和/或PQ測(cè)試需要重復(fù)進(jìn)行，以確認(rèn)儀器仍然能很好地運(yùn)行。如果儀器移到另一位置，則需要評(píng)估哪些OQ測(cè)試需重復(fù)進(jìn)行（如果有的話(huà)）。 OQ tests can be modular or holistic. Modular testing of individual components of a system may facilitate interchanging of such components without requalification. Ho

55、listic tests, which involve the entire system, are also acceptable. OQ測(cè)試可以模塊化或整體化。系統(tǒng)的單獨(dú)部分的模塊測(cè)試可以方便這樣的部分進(jìn)行交換而無(wú)需重新確認(rèn)。包含全部系統(tǒng)的整體測(cè)試也可以接受。 PERFORMANCE QUALIFICATION 性能確認(rèn) Performance qualification (PQ) is the documented collection of activities necessary to demonstrate that an instrument consistently pe

56、rforms 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 suitability for its intended use is demonstrated through performance qualification. The PQ phase may include the following parameters.

57、性能確認(rèn)（PQ）用于證實(shí)儀器始終按照使用者的規(guī)范運(yùn)行，并符合預(yù)期用途。IQ和OQ完成之后，通過(guò)PQ確認(rèn)來(lái)證實(shí)儀器對(duì)其預(yù)期用途的持續(xù)適用性。PQ階段包括以下參數(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 consi

58、st of analyzing known components or standards. The tests should be based on good science and reflect the general intended use of the instrument. Some system suitability tests or quality control checks that are performed concurrently with the test samples can be used to demonstrate that the instrumen

59、t is performing suitably. PQ tests may resemble those performed during OQ, but the specifications for their results may be set differently if required. Nevertheless, user specifications for PQ tests should demonstrate trouble-free instrument operation for the intended applications. As is the case wi

60、th OQ testing, PQ tests may be modular or holistic. 性能檢查—設(shè)立一個(gè)或一系列測(cè)試來(lái)確認(rèn)儀器具有滿(mǎn)足其預(yù)期用途的性能。PQ測(cè)試通?；趦x器典型的現(xiàn)場(chǎng)應(yīng)用，并且可以包含分析已知組分或標(biāo)準(zhǔn)物。測(cè)試應(yīng)具備良好的科學(xué)基礎(chǔ)并反應(yīng)該儀器的一般預(yù)期用途。與試樣同時(shí)進(jìn)行的一些系統(tǒng)適用性測(cè)試或質(zhì)量控制檢查可用于證明儀器可適當(dāng)?shù)剡\(yùn)行。PQ與OQ測(cè)試可能相同，但其結(jié)果的標(biāo)準(zhǔn)設(shè)定根據(jù)需要可以不同。盡管如此，用戶(hù)標(biāo)準(zhǔn)的PQ測(cè)試應(yīng)確定儀器在預(yù)期用途上的無(wú)故障運(yùn)行。同OQ測(cè)試一樣，PQ測(cè)試也可模塊化或整體化。 Testing frequency depends on

61、 the ruggedness of the instrument and the criticality of the tests performed. Testing may be unscheduled—for example, each time the instrument is used. It may also be scheduled for regular intervals. Experience with the instrument can influence this decision. It may be useful to repeat the same PQ t

62、ests each time the instrument is used so that a history of the instruments performance can be compiled. Alternatively, the instrument may be incorporated into an integrated support system to assure that it remains continually qualified. Some system suitability tests or quality control checks that ar

63、e performed concurrently with the test samples also imply that the instrument is performing suitably. 測(cè)試頻率取決于儀器的耐用性和測(cè)試表現(xiàn)出的重要性。測(cè)試可不定期進(jìn)行—如儀器每次使用時(shí)。也可制定定期計(jì)劃。使用該儀器的具體情況可以影響這個(gè)頻率。儀器每次使用前重復(fù)相同的PQ測(cè)試是很有用的，以便能記錄該儀器的歷史性能。另外，該儀器可納入支持系統(tǒng)以確保其持續(xù)保持已確認(rèn)的狀態(tài)。與試樣同時(shí)進(jìn)行的一些系統(tǒng)適用性試驗(yàn)或質(zhì)量控制檢查也暗示著該儀器可適當(dāng)?shù)剡\(yùn)行。 Preventive Maintenance

64、and Repairs— When an instrument fails to meet PQ test specifications, it requires maintenance or repair. A periodic preventive maintenance may also be recommended for many instruments. The relevant PQ test(s) should be repeated after the needed maintenance or repair to ensure that the instrument rem

65、ains qualified. 預(yù)防性維護(hù)和維修—當(dāng)儀器未能達(dá)到PQ測(cè)試標(biāo)準(zhǔn)，則該儀器需要維護(hù)或維修。建議對(duì)許多儀器進(jìn)行定期預(yù)防性維護(hù)。需要的維護(hù)或維修后需重復(fù)相關(guān)的PQ測(cè)試以確保儀器處于合格狀態(tài)。 Practices for Operation, Calibration, Maintenance, and Change Control— Establish practices to maintain and calibrate the instrument. Each maintenance and calibration activity should be documented.

66、 運(yùn)行、校正、維護(hù)和變更控制的規(guī)程—建立儀器維護(hù)和校正的操作規(guī)范。每次維護(hù)和校正均應(yīng)文件記錄。 ROLES AND RESPONSIBILITIES 角色和職責(zé) Users使用者 Users are ultimately responsible for instrument operations and data quality. The users group encompasses analysts, their supervisors, instrument specialists, and organization management. Users should be adequately trained in the instruments use, and their training records should be maintained as required by the regulations. 使用者最終負(fù)責(zé)儀器的操作和數(shù)據(jù)質(zhì)量。使用者包括分析員及其監(jiān)督者、儀器專(zhuān)家、組織管理層。使用者應(yīng)就儀器的使用進(jìn)行