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近日,世界衛(wèi)生組織（WHO）發(fā)布 質(zhì)量控制實驗室原則上可接受性評估程序的草案，闡述了WHO列名 質(zhì)量控制實驗室符合WHO《藥品質(zhì)量控制實驗室良好規(guī)范》（GPPQCL）、《藥品微生物實驗室良好規(guī)范》以及《藥品生產(chǎn)質(zhì)量管理規(guī)范》（GMP）的相關(guān)部分和 WHO《國家監(jiān)管機(jī)構(gòu)質(zhì)量管理體系實施指南》（NRA 的 QMS）的評估程序：
以下為原文及其翻譯
WHO listing of quality control laboratories:procedure for assessing the acceptability, inprinciple, of quality control laboratories for use by United Nations agencies .
世界衛(wèi)生組織（WHO）質(zhì)量控制實驗室列名：聯(lián)合國機(jī)構(gòu)所用質(zhì)量控制實驗室原則性可接受性評估程序
Table of contents
目錄
1. Steps of the procedure
1.1 Publication of invitation for Expressions of Interest
1.2 Submission of EOIs and laboratory information
1.3 Screening of submitted laboratory information
1.4 Evaluation of the laboratory information
1.5 Site inspection
1.6 Report and outcome of inspection
1.7 Results of assessment
1.8 Monitoring of WLQCLs
1.9 Monitoring of complaints
1.10 Cost recovery
1.11 Con?dentiality undertaking
1.12 Conflict of interest
程序步驟
1.1 發(fā)布意向征集公告
1.2 提交意向書及實驗室信息
1.3 篩選提交的實驗室信息
1.4 評估實驗室信息
1.5 實地考察
1.6 考察報告及結(jié)果
1.7 評估結(jié)果
1.8 對世界衛(wèi)生組織合作中心實驗室（WLQCLs）的監(jiān)測
1.9 對投訴的監(jiān)測
1.10 成本回收
1.11 保密承諾
1.12 利益沖突
Introduction
引言
his document provides an update of the procedure originally published as Annex 12 in World Health Organization (WHO) Technical Report Series (TRS), No. 961, 2011, and updated for the first time in Annex 3 of the WHO TRS No. 1003, 2017. WHO provides United Nations (UN) agencies, their partners, procurement agencies serving national authorities and UN agencies and/or national authorities of WHO Member States, on request, with advice on the acceptability, in principle, of quality control laboratories (QCLs) that are found to meet WHO-recommended quality standards for such laboratories. These standards are set out in Good practices for pharmaceutical quality control laboratories (GPPQCL) (1), and include, where applicable, good practices for pharmaceutical microbiology laboratories (2), as well as the relevant parts of good manufacturing practices (GMP) (3) and of the WHO guideline on the implementation of quality management systems for national regulatory authorities (QMS for NRA) (4). This is done through a standardized quality assessment procedure. The purpose of the quality assessment procedure is to evaluate whether the QCLs to be used for the quality control of pharmaceutical products meet the requirements recommended by WHO for such laboratories.
本文件是對最初作為世界衛(wèi)生組織（WHO）《技術(shù)報告系列》（TRS）第 961 號（2011 年）附件 12 發(fā)布，并在 WHO《技術(shù)報告系列》第 1003 號（2017 年）附件 3 中首次更新的程序的最新修訂。應(yīng)要求，WHO 向聯(lián)合國（UN）各機(jī)構(gòu)、其合作伙伴、為國家當(dāng)局和聯(lián)合國機(jī)構(gòu)服務(wù)的采購機(jī)構(gòu)以及 WHO 會員國的國家當(dāng)局，就被認(rèn)定符合 WHO 為此類實驗室推薦的質(zhì)量標(biāo)準(zhǔn)的質(zhì)量控制實驗室（QCLs）在原則上的可接受性提供建議。這些標(biāo)準(zhǔn)載于《藥品質(zhì)量控制實驗室良好規(guī)范》（GPPQCL）（1），并在適用情況下包括《藥品微生物實驗室良好規(guī)范》（2），以及《藥品生產(chǎn)質(zhì)量管理規(guī)范》（GMP）（3）的相關(guān)部分和 WHO《國家監(jiān)管機(jī)構(gòu)質(zhì)量管理體系實施指南》（NRA 的 QMS）（4）。這是通過標(biāo)準(zhǔn)化的質(zhì)量評估程序完成的。質(zhì)量評估程序的目的是評估用于藥品質(zhì)量控制的 QCLs 是否符合 WHO 為此類實驗室推薦的要求。
Participation in the procedure for the designation as a WHO-listed quality control laboratory (WLQCL) is voluntary and any pharmaceutical QCL (governmental or private) providing quality control services for pharmaceutical products to UN agencies, their partners,procurement agencies serving national authorities and UN agencies and/or national authorities of WHO Member States is eligible.
參與被指定為WHO列名質(zhì)量控制實驗室（WLQCL）的程序是自愿的，任何為聯(lián)合國機(jī)構(gòu)、其合作伙伴、為國家當(dāng)局和聯(lián)合國機(jī)構(gòu)服務(wù)的采購機(jī)構(gòu)以及 / 或世界衛(wèi)生組織會員國的國家當(dāng)局提供藥品質(zhì)量控制服務(wù)的藥品質(zhì)量控制實驗室（政府或私人性質(zhì)）均有資格參與。
Accreditation, such as ISO (in terms of ISO/IEC17025), is encouraged and will also be considered in the procedure for designation as a WLQCL. Laboratories are recommended to work towards obtaining accreditation. In addition, for official (governmental) quality control laboratories, WLQCL listing requires that the regulatory system to which the laboratory belongs has achieved maturity level 3 for the laboratory function, as assessed through the WHO Global Benchmarking Tool (GBT) (5). More broadly, the regulatory authority responsible for the overarching national regulatory system of medical products is encouraged to strive towards maturity level 3 across all regulatory functions.
鼓勵通過認(rèn)證（如符合 ISO/IEC17025 標(biāo)準(zhǔn)的 ISO 認(rèn)證），且該認(rèn)證也會在指定為 WLQCL 的程序中予以考慮。建議實驗室致力于獲得認(rèn)證。此外，對于官方（政府）質(zhì)量控制實驗室，WLQCL 列名要求該實驗室所屬的監(jiān)管體系通過 WHO 全球基準(zhǔn)工具（GBT）（5）評估，在實驗室職能方面達(dá)到成熟度 3 級。更廣泛地說，鼓勵負(fù)責(zé)國家醫(yī)療產(chǎn)品總體監(jiān)管體系的監(jiān)管機(jī)構(gòu)在所有監(jiān)管職能方面努力達(dá)到成熟度 3 級。
The assessment procedure established by WHO is based on the following principles:
世界衛(wèi)生組織制定的評估程序基于以下原則：
•evidence that the laboratory provides or is committed to offering quality control services for pharmaceutical products to UN agencies and their partners, procurement agencies serving national authorities and UN agencies and/or national authorities of WHO Member States;
•實驗室提供或承諾為聯(lián)合國機(jī)構(gòu)及其合作伙伴、為國家當(dāng)局和聯(lián)合國機(jī)構(gòu)服務(wù)的采購機(jī)構(gòu)以及 / 或世界衛(wèi)生組織會員國的國家當(dāng)局提供藥品質(zhì)量控制服務(wù)的證據(jù)；
•a general understanding of the documented quality management system and quality control testing activities of the laboratory, including the use of the International Pharmacopoeia and other recognized pharmacopoeias;
•對實驗室文件化質(zhì)量管理體系和質(zhì)量控制檢測活動的總體了解，包括對《國際藥典》及其他公認(rèn)藥典的使用；
•evaluation of information submitted by the laboratory
•對實驗室提交信息的評估；
•assessment of compliance with WHO-recommended quality standards for QCLs, i.e. GPPQCL(1), including, where applicable, good practices for pharmaceutical microbiology laboratories(2), as well as the relevant parts of GMP (3) and of the guideline on the implementation of QMS for NRA (4);
•對符合世界衛(wèi)生組織推薦的質(zhì)量控制實驗室（QCLs）質(zhì)量標(biāo)準(zhǔn)（即《藥品質(zhì)量控制實驗室良好規(guī)范》（GPPQCL，編號 1））的合規(guī)性評估，適用時包括《藥品微生物實驗室良好規(guī)范》（編號 2），以及《藥品生產(chǎn)質(zhì)量管理規(guī)范》（GMP，編號 3）和《國家監(jiān)管機(jī)構(gòu)質(zhì)量管理體系實施指南》（編號 4）的相關(guān)部分；
•monitoring of performance of WLQCLs and their compliance with WHO requirements.
•對世界衛(wèi)生組織列名質(zhì)量控制實驗室（WLQCLs）的性能及其遵守世衛(wèi)組織要求的情況進(jìn)行監(jiān)測。
WHO invites the national regulatory authority (NRA), having regulatory oversight over a laboratory participating in the WLQCL procedure, to join as an observer in the inspection of the laboratory’s compliance with WHO-recommended standards for QCLs. WHO recommends that laboratories expressing an interest in participating in the WLQCL procedure inform the regulatory authority of the country in which they are established as well as relevant networks (for example, the general European of?cial medicines control laboratories network) of their submission for designation as a WLQCL.
世衛(wèi)組織邀請對參與 WLQCL 程序的實驗室具有監(jiān)管監(jiān)督權(quán)的國家監(jiān)管機(jī)構(gòu)（NRA）作為觀察員參與實驗室是否符合世衛(wèi)組織推薦的 QCL 標(biāo)準(zhǔn)的檢查。世衛(wèi)組織建議，有興趣參與 WLQCL 程序的實驗室應(yīng)將其申請指定為 WLQCL 的事宜通知其所在國家的監(jiān)管機(jī)構(gòu)以及相關(guān)網(wǎng)絡(luò)（例如，歐洲官方藥品控制實驗室通用網(wǎng)絡(luò)）。
This procedure is to be followed for WLQCL listing of QCLs for use by UN agencies and their partners, procurement agencies serving national authorities and UN agencies and/or national authorities of WHO Member States.
本程序適用于將質(zhì)量控制實驗室（QCLs）列入世界衛(wèi)生組織清單（WLQCL），以供聯(lián)合國機(jī)構(gòu)及其合作伙伴、為國家當(dāng)局和聯(lián)合國機(jī)構(gòu)服務(wù)的采購機(jī)構(gòu)以及 / 或世界衛(wèi)生組織會員國的國家當(dāng)局使用。
1. Steps of the procedure
1. 程序步驟
WHO requires information related to the activities of, and quality control of pharmaceutical products in, laboratories interested in being assessed under this procedure. Interested QCLs should submit the information about their activities as requested by WHO (see point 1.2 below). In addition to the evaluation of the information submitted,a site inspection (or inspections) maybe performed.WHO
要求有意按照本程序接受評估的實驗室提供與其活動及藥品質(zhì)量控制相關(guān)的信息。感興趣的 QCLs 應(yīng)按 WHO 要求（見下文 1.2 點）提交其活動信息。除了評估提交的信息外，還可能進(jìn)行一次或多次現(xiàn)場檢查。
If, due to insuf?cient resources and time constraints, WHO has to set priorities in the assessment of interested laboratories, then priority will be given to QCLs in areas where UN agencies, their partners, procurement agencies serving national authorities and UN agencies and/or national authorities of WHO Member States identify the need for testing of the quality of pharmaceutical products.
如果由于資源不足和時間限制，WHO 必須在評估感興趣的實驗室時確定優(yōu)先順序，那么將優(yōu)先考慮聯(lián)合國機(jī)構(gòu)及其合作伙伴、為國家當(dāng)局和聯(lián)合國機(jī)構(gòu)服務(wù)的采購機(jī)構(gòu)，以及 WHO 成員國的國家當(dāng)局確定有藥品質(zhì)量檢測需求地區(qū)的 QCLs。
Applications from laboratories that belong to or are affiliated with a manufacturer of pharmaceutical products, particularly those that have an interest in having one or more of their products prequalified by WHO or whose product(s) is/are already prequalified by WHO, may be given lower priority or may not be evaluated at all.
屬于或附屬于藥品制造商的實驗室提交的申請，尤其是那些希望其一種或多種產(chǎn)品獲得 WHO 預(yù)認(rèn)證，或其產(chǎn)品已獲得 WHO 預(yù)認(rèn)證的實驗室，其申請可能會被給予較低優(yōu)先級，甚至可能不予評估。
WHO reserves the right to terminate the quality assessment of a laboratory when the laboratory is not able to provide, or fails to provide, the required information, when the information supplied is inadequate to complete the quality assessment effectively, and when the laboratory fails to collaborate in inspections required by WHO and/or is unable to implement corrective actions that WHO may require within a speci?ed time period.
如果實驗室無法提供或未能提供所需信息，提供的信息不足以有效完成質(zhì)量評估，以及實驗室未能配合 WHO 要求的檢查，和 / 或未能在規(guī)定時間內(nèi)實施 WHO 可能要求的糾正措施，WHO 保留終止對該實驗室質(zhì)量評估的權(quán)利。
1.1 Publication of invitation for Expressions of Interest
1.1 發(fā)布意向征集邀請
WHO will publish an invitation to QCLs to submit an Expression of Interest (EOI) to participate in the WLQCL procedure. Such an invitation will specify the scope of quality control testing which is subject toWLQCL listing and will be published widely, i.e. on the WHO website and possibly also through other media, such as the international press. The invitation will be open and transparent, inviting all interested QCLs to submit an EOI for WLQCL listing.
WHO 將發(fā)布邀請，邀請 QCLs 提交參與 WLQCL 程序的意向書（EOI）。該邀請將明確受 WLQCL 清單約束的質(zhì)量控制檢測范圍，并將廣泛發(fā)布，即在 WHO 網(wǎng)站上發(fā)布，也可能通過其他媒體，如國際新聞媒體發(fā)布。邀請將公開透明，邀請所有感興趣的 QCLs 提交列入 WLQCL 清單的 EOI。
1.2 Submission of EOIs and laboratory information
1.2 提交意向書及實驗室信息
Each interested laboratory should provide the WHO focal point indicated in the invitation for EOIs with:
各有意向的實驗室應(yīng)按意向書邀請中注明的方式，向世界衛(wèi)生組織（WHO）聯(lián)絡(luò)點提供以下內(nèi)容：
• a cover letter expressing interest in participating in the WLQCL procedure;
•evidence that the laboratory provides, or is committed to offering, quality control services for pharmaceutical products to UN agencies, their partners, procurement agencies serving national authorities and UN agencies and/or national authorities of WHO Member States; and•therelevantlaboratoryinformation.
• 一封表明有興趣參與世界衛(wèi)生組織藥品質(zhì)量控制實驗室程序（WLQCL）的求職信；
• 證據(jù)證明實驗室已向或承諾向聯(lián)合國機(jī)構(gòu)及其合作伙伴、為國家當(dāng)局和聯(lián)合國機(jī)構(gòu)提供服務(wù)的采購機(jī)構(gòu)，以及（或）世界衛(wèi)生組織成員國的國家當(dāng)局提供藥品質(zhì)量控制服務(wù)；• 相關(guān)實驗室信息。
WHO will record the receipt of the EOI from each laboratory in a register. If the laboratory has documented its quality system as a quality manual, this can be submitted, provided that it is supplemented with the information required for the laboratory information ?le (LIF) (see below) that is not provided in the quality manual.
世衛(wèi)組織將把每個實驗室提交的意向書收訖情況記錄在登記冊中。若實驗室已通過質(zhì)量手冊對其質(zhì)量體系進(jìn)行了文件化說明，則可提交該手冊，但需補(bǔ)充質(zhì)量手冊中未包含的實驗室信息檔案（LIF）所需信息（見下文）。
The information should be submitted as described in the document Guidelines for preparing a laboratory information ?le (6) and cover the areas listed below, which are based on and complement the content of the Guidelines:
相關(guān)信息應(yīng)按照《實驗室信息檔案編制指南》（6）文件中的說明提交，并涵蓋以下所列領(lǐng)域，這些領(lǐng)域基于該指南的內(nèi)容并對其進(jìn)行補(bǔ)充：
general information on the laboratory, including activities proposed for WLQCL listing;
實驗室的基本信息，包括擬列入世界衛(wèi)生組織藥品質(zhì)量控制實驗室程序（WLQCL）的活動清單；
riskmanagement
風(fēng)險管理
performancemanagement;
績效管理
crisis management
危機(jī)管理
communication management
溝通管理
participation in pro?ciency testing schemes and/or collaborative trials;
參與能力驗證計劃和 / 或協(xié)作試驗
internal audits
內(nèi)部審計
control of data, documentation and records;
數(shù)據(jù)、文件和記錄的控制
personnel
人員
premises
場所
equipment
設(shè)備
reagents, reference substances and reference materials;
試劑、參考物質(zhì)和標(biāo)準(zhǔn)物質(zhì)
subcontracting of testing (where applicable);
檢測分包（如適用）；
handling of samples;
樣品處理
validation and verification of analytical procedures;
分析程序的驗證和確認(rèn)
evaluation and reporting of results;
結(jié)果的評估與報告；
investigation of out-of-speci?cation (OOS) results;
超標(biāo)（OOS）結(jié)果的調(diào)查
uncertainty of measurement;
測量不確定度
stability testing (where applicable)
穩(wěn)定性測試（如適用）
microbiological testing (where applicable);
微生物檢測（如適用）
testing of vaccines (where applicable);
疫苗檢測（如適用）
testing of biologicals and advanced therapy medicinal products (where applicable) .
生物制品和先進(jìn)治療藥品的檢測（如適用）。
Guidelines for the submission of EOIs and for the preparation and submission of the relevant information are available on the WHO website at (http://apps.who.int/prequal/) and will be sent to interested laboratories upon request.
關(guān)于提交意向書（EOI）以及相關(guān)信息的準(zhǔn)備和提交指南，可在世衛(wèi)組織網(wǎng)站（http://apps.who.int/prequal/）上獲取，也可根據(jù)申請向感興趣的實驗室發(fā)送。
1.3 Screening of submitted laboratory information
1.3 所提交實驗室信息的篩選
The Guidelines for preparing alaboratoryinformation ?le(6) willbeusedin aninitial screening oftheinformationsupplied.Theinformationwillnotbeevaluatedifitisnotcomplete.Insuchcasesthelaboratory will be requested to provide additional information within a specified time. Ifthe additionalinformationisnotreceivedby the deadline, the application willberejected.
實驗室信息文件編制指南（6）將用于對所提供信息的初步篩選。若信息不完整，將不予評估。在此情況下，將要求實驗室在指定時間內(nèi)提供補(bǔ)充信息。若未在截止日期前收到補(bǔ)充信息，申請將被駁回。
1.4 Evaluation of the laboratory information
1.4 實驗室信息評估
Laboratory information that complies with the requirements set out in section 1.2 will be evaluated in accordance with a standard operating procedure (SOP) established by WHO to ensure uniformity in evaluation of the information. The information will be evaluated against the WHO-recommended quality standards for QCLs, i.e. GPPQCL (1), including, where applicable, good practices for pharmaceutical microbiology laboratories (2), as well as the relevant parts of GMP (3) and of the guideline on the implementation of QMS for NRA (4), and the laboratory will be considered for a possible site inspection
符合第 1.2 節(jié)規(guī)定要求的實驗室信息，將根據(jù)世界衛(wèi)生組織（WHO）制定的標(biāo)準(zhǔn)操作規(guī)程（SOP）進(jìn)行評估，以確保信息評估的一致性。該信息將對照 WHO 為合格評定實驗室（QCLs）推薦的質(zhì)量標(biāo)準(zhǔn)進(jìn)行評估，即《藥品質(zhì)量控制實驗室良好實踐》（GPPQCL，參考文獻(xiàn) 1），包括適用情況下的《制藥微生物學(xué)實驗室良好實踐》（參考文獻(xiàn) 2），以及《藥品生產(chǎn)質(zhì)量管理規(guī)范》（GMP，參考文獻(xiàn) 3）和《國家監(jiān)管機(jī)構(gòu)質(zhì)量管理體系實施指南》（參考文獻(xiàn) 4）的相關(guān)部分。實驗室可能會被考慮進(jìn)行現(xiàn)場檢查。
A laboratory may submit the report of the inspection or audit performed by a regulatory authority applying standards at least equivalent to WHO-recommended quality standards for QCLs,i.e. GPPQCL (1), including, where applicable, good practices for pharmaceutical microbiology laboratories (2), as well as the relevant parts of GMP (3) and of the guideline on the implementation of QMS for NRA (4), and the response of the laboratory to the observations made by the authority during inspection or audit.
實驗室可提交由監(jiān)管機(jī)構(gòu)依據(jù)至少等同于世界衛(wèi)生組織（WHO）為合格評定實驗室（QCLs）推薦的質(zhì)量標(biāo)準(zhǔn) [即《藥品質(zhì)量控制實驗室良好實踐》（GPPQCL，參考文獻(xiàn) 1），包括適用情況下的《制藥微生物學(xué)實驗室良好實踐》（參考文獻(xiàn) 2）、《藥品生產(chǎn)質(zhì)量管理規(guī)范》（GMP，參考文獻(xiàn) 3）相關(guān)部分，以及《國家監(jiān)管機(jī)構(gòu)質(zhì)量管理體系實施指南》（參考文獻(xiàn) 4）相關(guān)部分] 開展的檢查或?qū)徲媹蟾?，連同實驗室針對監(jiān)管機(jī)構(gòu)在檢查或?qū)徲嬤^程中提出的意見所作的回應(yīng)。
Based on an SOP established by WHO for review of external inspections and audits, if the laboratory is considered to be operating at an acceptable level of compliance with WHO-recommended standards, WHO may decide that it is not necessary to conduct a site inspection.
根據(jù)世界衛(wèi)生組織（WHO）制定的外部檢查和審計審查標(biāo)準(zhǔn)操作規(guī)程（SOP），若實驗室被認(rèn)定在符合 WHO 推薦標(biāo)準(zhǔn)方面達(dá)到可接受的合規(guī)水平，WHO 可能會決定無需進(jìn)行現(xiàn)場檢查。
1.5 Site inspection
1.5 現(xiàn)場檢查
Depending on the outcome of the evaluation of the laboratory information, WHO may plan and coordinate inspections of the laboratory to assess compliance with WHO-recommended quality standards for such laboratories, i.e. GPPQCL (1), including where applicable good practices for pharmaceutical microbiology laboratories (2), as well as the relevant parts of GMP (3) and of the guideline on the implementation of QMS for NRA (4).1 The inspection will be performed by an inspector, or a team of inspectors, having the relevant quali?cations and experience in the ?eld of quality control of pharmaceutical products.
根據(jù)對實驗室信息的評估結(jié)果，世界衛(wèi)生組織（WHO）可能會規(guī)劃并協(xié)調(diào)對實驗室的檢查，以評估其是否符合 WHO 為這類實驗室推薦的質(zhì)量標(biāo)準(zhǔn)，即《藥品質(zhì)量控制實驗室良好實踐》（GPPQCL，參考文獻(xiàn) 1），包括適用情況下的《制藥微生物學(xué)實驗室良好實踐》（參考文獻(xiàn) 2），以及《藥品生產(chǎn)質(zhì)量管理規(guī)范》（GMP，參考文獻(xiàn) 3）和《國家監(jiān)管機(jī)構(gòu)質(zhì)量管理體系實施指南》（參考文獻(xiàn) 4）的相關(guān)部分。檢查工作將由具備藥品質(zhì)量控制領(lǐng)域相關(guān)資質(zhì)和經(jīng)驗的一名或一組檢查員執(zhí)行。
External inspectors will be appointed in accordance with WHO procedures and will act as temporary advisers to WHO. The external inspectors must comply with the con?dentiality and con?ict of interest rules of WHO, as laid down in the relevant sections of this procedure. A WHO staff member will coordinate the team. The inspector or inspection team will perform the inspections and report on the ?ndings in accordance with SOPs established by WHO to ensure a standard harmonized approach.
外部檢查員將根據(jù)世衛(wèi)組織（WHO）程序任命，并擔(dān)任世衛(wèi)組織的臨時顧問。外部檢查員必須遵守本程序相關(guān)章節(jié)規(guī)定的世衛(wèi)組織保密和利益沖突規(guī)則。世衛(wèi)組織工作人員將對檢查小組進(jìn)行協(xié)調(diào)。檢查員或檢查小組將按照世衛(wèi)組織制定的標(biāo)準(zhǔn)操作規(guī)程（SOP）開展檢查并報告檢查結(jié)果，以確保采用統(tǒng)一的標(biāo)準(zhǔn)方法。
A representative or representatives of the NRA having regulatory oversight over a laboratory participating in the WLQCL procedure will be invited to accompany the team as an observer.
對參與世界衛(wèi)生組織合格評定實驗室（WLQCL）程序的實驗室負(fù)有監(jiān)管職責(zé)的國家監(jiān)管機(jī)構(gòu)（NRA），其一名或多名代表將被邀請作為觀察員隨同檢查小組參與檢查。
With a view to coordinating inspection activities, avoiding duplication and promoting information sharing without prejudice to the protection of any con?dential and proprietary information of the laboratory in accordance with the terms of this procedure, WHO may disclose inspection-related information to regulatory authorities of WHO Member States, UN agencies and to the European Directorate for the Quality of Medicines & HealthCare.
為協(xié)調(diào)檢查活動、避免重復(fù)工作并促進(jìn)信息共享，同時根據(jù)本程序條款保護(hù)實驗室的任何機(jī)密和專有信息，世界衛(wèi)生組織（WHO）可向其成員國監(jiān)管機(jī)構(gòu)、聯(lián)合國機(jī)構(gòu)以及歐洲藥品和保健質(zhì)量局披露與檢查相關(guān)的信息。
1.6 Report and outcome of inspection
1.6 檢查報告與結(jié)果
The inspector or inspection team will ?nalize a report describing the ?ndings according to the established WHO SOP and format. The report will be communicated by WHO to the laboratory and a copy will be sent to the NRA having regulatory oversight over the laboratory.
檢查員或檢查小組將根據(jù)世衛(wèi)組織（WHO）既定的標(biāo)準(zhǔn)操作規(guī)程（SOP）和格式，完成一份描述檢查結(jié)果的報告。世衛(wèi)組織將把該報告?zhèn)鬟_(dá)給實驗室，并向?qū)υ搶嶒炇邑?fù)有監(jiān)管職責(zé)的國家監(jiān)管機(jī)構(gòu)（NRA）發(fā)送副本。
If any additional information is required, or if a corrective action has to betaken by the laboratory, WHO will postpone its decision on the acceptability of the laboratory concerned until the additional information has been evaluated, or the corrective action has been taken, and found satisfactory. If the decision cannot be made based on the information received,a follow-up inspection will be performed.
若需要補(bǔ)充信息，或?qū)嶒炇冶仨毑扇〖m正措施，世衛(wèi)組織（WHO）將暫緩對相關(guān)實驗室是否合格的決定，直至補(bǔ)充信息評估完畢或糾正措施已落實且結(jié)果令人滿意。若根據(jù)所收到的信息仍無法作出決定，則將進(jìn)行后續(xù)檢查。
In the event of any disagreement between a laboratory and WHO, an SOP for the handling of such disagreements will be followed to discuss and resolve the issue.
若實驗室與世界衛(wèi)生組織（WHO）之間出現(xiàn)任何分歧，應(yīng)遵循處理此類分歧的標(biāo)準(zhǔn)操作規(guī)程（SOP）來討論并解決相關(guān)問題。
As WHO is responsible for the quality assessment procedure, the ownership of the reports lies with WHO (without prejudice, however, to any con?dentialand proprietary information of the laboratory contained in this report). Thus, WHO shall be entitled to use and publish such reports subject always, however, to the protection of any con?dential and proprietary information of the laboratory. “Con?dential information” in this context means:
由于世界衛(wèi)生組織（WHO）負(fù)責(zé)質(zhì)量評估程序，報告的所有權(quán)歸 WHO 所有（但不影響報告中包含的實驗室任何機(jī)密和專有信息）。因此，WHO 有權(quán)使用和發(fā)布此類報告，但始終需保護(hù)實驗室的任何機(jī)密和專有信息。此處 “機(jī)密信息” 指：
• con?dential intellectual property, “know-how” and trade secrets (including, for example, programmes, processes or methods, unpublished aspects of trademarks and patents); • commercial con?dences (for example, structures and development plans).
•機(jī)密知識產(chǎn)權(quán)、“專有技術(shù)” 和商業(yè)秘密（包括例如程序、工藝或方法，以及未公開的商標(biāo)和專利內(nèi)容）；•商業(yè)機(jī)密（例如企業(yè)架構(gòu)和發(fā)展規(guī)劃）。
Provisions of con?dentiality will be contained in the letters exchanged between WHO and the laboratory, to be agreed upon before the evaluation of the information and site inspection.
世界衛(wèi)生組織（WHO）與實驗室之間往來的信函中將包含保密條款，這些條款需在信息評估和現(xiàn)場檢查前達(dá)成一致。
Notwithstanding the foregoing, WHO reserves the right to share the full reports with the relevant authorities of any interested Member State of the Organization and interested UN agencies.
盡管有上述規(guī)定，世界衛(wèi)生組織（WHO）仍保留向本組織任何相關(guān)成員國的主管部門及相關(guān)聯(lián)合國機(jī)構(gòu)分享完整報告的權(quán)利。
1.7 Results of assessment
1.7 評估結(jié)果
Once WHO is satis?ed that the quality assessment process for the laboratory is complete, and that the laboratory is acceptable in principle for use by UN agencies and their partners, procurement agencies serving national authorities and UN agencies and/or national authorities of WHO Member States (i.e. it has been found to meet the WHO-recommended quality standards for QCLs), the laboratory at the speci?ed site will be included in a list referred to as “List of WHO-listed quality control laboratories” .
一旦世界衛(wèi)生組織（WHO）確認(rèn)該實驗室的質(zhì)量評估流程已完成，且原則上認(rèn)可其可供聯(lián)合國機(jī)構(gòu)及其合作伙伴、為國家當(dāng)局和聯(lián)合國機(jī)構(gòu)服務(wù)的采購機(jī)構(gòu)，以及 / 或 WHO 成員國的國家當(dāng)局使用（即認(rèn)定其符合 WHO 為質(zhì)量控制實驗室推薦的質(zhì)量標(biāo)準(zhǔn)），該指定地點的實驗室將被列入 “WHO 認(rèn)證質(zhì)量控制實驗室清單”。
Laboratories on the list will be considered to be able to test products in compliance with WHO- recommended quality standards for QCLs. Inclusion in the list does not, however, imply any approval by WHO of the laboratories (which is the sole prerogative of national authorities).
清單上的實驗室將被視為有能力按照世界衛(wèi)生組織（WHO）為質(zhì)量控制實驗室（QCLs）推薦的質(zhì)量標(biāo)準(zhǔn)對產(chǎn)品進(jìn)行檢測。然而，列入該清單并不意味著 WHO 對這些實驗室的任何認(rèn)可（此乃國家當(dāng)局的專屬職權(quán)）。
Before publication of its name on the list of WLQCLs, each laboratory will receive a letter from WHO informing it of the outcome of the quality assessment process for that particular laboratory.
在其名稱公布于世界衛(wèi)生組織認(rèn)證質(zhì)量控制實驗室清單（WLQCLs）之前，每個實驗室將收到世衛(wèi)組織的信函，告知其專項質(zhì)量評估流程的結(jié)果。
A copy of this letter will be sent to the NRA of the country where the laboratory is located. The list of WLQCLs will be published on the WHO website and will specify the areas of expertise assessed and considered listed. The list will be updated whenever new relevant information is obtained.
此信函的副本將被發(fā)送至實驗室所在國家的國家監(jiān)管機(jī)構(gòu)（NRA）。世界衛(wèi)生組織認(rèn)證質(zhì)量控制實驗室清單（WLQCLs）將公布于世衛(wèi)組織官網(wǎng)，并詳細(xì)列明所評估的專業(yè)領(lǐng)域及被認(rèn)定納入清單的領(lǐng)域。該清單將在獲取新的相關(guān)信息時及時更新。
In accordance with World Health Assembly Resolution WHA57.14 of 22 May 2004, WHO will – subject to the protection of any con?dential and proprietary information – publish WHO Public Inspection Reports on the laboratories considered to meet WHO-recommended quality standards for QCLs. These reports will be published on the WHO website.
根據(jù) 2004 年 5 月 22 日世界衛(wèi)生大會第 WHA57.14 號決議，世界衛(wèi)生組織（WHO）將在保護(hù)所有機(jī)密及專有信息的前提下，公布針對被認(rèn)定符合 WHO 為質(zhì)量控制實驗室（QCLs）推薦的質(zhì)量標(biāo)準(zhǔn)的實驗室的公開檢查報告。這些報告將在世衛(wèi)組織官網(wǎng)發(fā)布。
1.8 Monitoring of WLQCLs
1.8 世界衛(wèi)生組織認(rèn)證質(zhì)量控制實驗室（WLQCLs）的監(jiān)管
Once the laboratory is included in the list of WLQCLs, it should inform WHO without delay about the implementation of any changes that may have an impact on the WLQCL listing of the laboratory (such as changes to facility, equipment or key personnel) and should submit an updated LIF.
一旦實驗室被列入世界衛(wèi)生組織認(rèn)證質(zhì)量控制實驗室清單（WLQCLs），應(yīng)立即通知世衛(wèi)組織任何可能影響其清單資質(zhì)的變更情況（如設(shè)施、設(shè)備或關(guān)鍵人員變動），并提交更新后的實驗室信息表（LIF）。
Each WLQCL will be re-evaluated at regular intervals (annually) or earlier, when information indicating the necessity for re-evaluation is obtained by WHO.
每個世界衛(wèi)生組織認(rèn)證質(zhì)量控制實驗室（WLQCLs）均需定期（每年）重新評估；若世衛(wèi)組織獲取到表明有必要重新評估的信息，則可提前進(jìn)行評估。
To enable WHO to carry out re-evaluation, all WLQCLs are requested to submit a brief annual report on their activities. The report should cover all activities related to quality control of pharmaceutical products within the preceding three years and should be submitted by the end of March of the subsequent year. The following items should be included in the report:
為使世界衛(wèi)生組織（WHO）能夠開展重新評估，所有世界衛(wèi)生組織認(rèn)證質(zhì)量控制實驗室（WLQCLs）需提交其活動的年度簡要報告。該報告應(yīng)涵蓋過去三年與藥品質(zhì)量控制相關(guān)的全部活動，并應(yīng)于次年 3 月底前提交。報告應(yīng)包含以下內(nèi)容：
•a summary of services provided to UN agencies and their partners, procurement agencies serving national authorities and UN agencies and/or national authorities of WHO Member States;
•向聯(lián)合國機(jī)構(gòu)及其合作伙伴、為國家當(dāng)局和聯(lián)合國機(jī)構(gòu)服務(wù)的采購機(jī)構(gòu)，以及 / 或世界衛(wèi)生組織成員國國家當(dāng)局提供服務(wù)的概述；
•a summary of number of samples analysed, differentiating between compliant and noncompliant samples including anyOOS/out-of-trend investigations;
•分析樣品數(shù)量的概述，區(qū)分合規(guī)與不合規(guī)樣品，包括任何超標(biāo)（OOS）/ 趨勢外調(diào)查；
•a list of analytical methods used, including testing parameters and reference documents、
•所用分析方法的清單，包括檢測參數(shù)和參考文件；
•a summary of complaints received from customers concerning results of analyses performed by the laboratory;
•實驗室收到的客戶關(guān)于分析結(jié)果的投訴概述；
•brief details of participation in pro?ciency testing schemes (organizing party, methods involved,outcomes and, if appropriate, corrective measures adopted);
•參加能力驗證計劃的簡要詳情（組織方、涉及的方法、結(jié)果，以及適當(dāng)情況下采取的糾正措施）；
•listing of inspections and audits performed by external parties, identifying the party and the scope of the inspection and audit;
•外部機(jī)構(gòu)開展的檢查和審計清單，列明機(jī)構(gòu)名稱及檢查審計范圍；
•confirmation of the primary and secondary contact points;
•主要和次要聯(lián)絡(luò)點的確認(rèn)信息；
•in the case that changes have been implemented, which have an impact on the content of the LIF, a summary of these changes should be included in the report and an updated LIF should be attached.
•若已實施對實驗室信息表（LIF）內(nèi)容有影響的變更，報告中應(yīng)包含這些變更的概述，并附上更新后的 LIF。
•WHO will conduct re-inspections of WLQCLs in accordance with SOPs established by WHO
.•世界衛(wèi)生組織（WHO）將根據(jù)其制定的標(biāo)準(zhǔn)操作程序（SOPs）對世界衛(wèi)生組織認(rèn)證質(zhì)量控制實驗室（WLQCLs）進(jìn)行重新檢查。
The frequency of such re- inspections depends on WHO’s assessment of the quality risk management factors described below. Normally, however, such re-inspections will take place at least once every three years. The following factors will betaken into account when planning inspections:
此類重新檢查的頻率取決于世界衛(wèi)生組織（WHO）對下述質(zhì)量風(fēng)險管理因素的評估。不過，通常情況下，此類重新檢查至少每三年進(jìn)行一次。規(guī)劃檢查時將考慮以下因素：
• major changes, for example, to premises, equipment or key personnel;
• 重大變更，例如場所、設(shè)備或關(guān)鍵人員的變更；
• the results of previous inspection(s)/audit(s) by WHO or another external party, and history of compliance of the laboratory with WHO-recommended quality standards;
• 世界衛(wèi)生組織（WHO）或其他外部機(jī)構(gòu)先前檢查 / 審計的結(jié)果，以及實驗室遵守 WHO 推薦質(zhì)量標(biāo)準(zhǔn)的歷史記錄；
• the outcomes of participation of the laboratory in pro?ciency testing schemes;
• 實驗室參加能力驗證計劃的結(jié)果；
• number and signi?cance of complaints made known to the QCL by customers;
• 客戶向質(zhì)量控制實驗室（QCL）反饋的投訴數(shù)量及其重要性；
• laboratory experience with testing of pharmaceutical products
• 實驗室在藥品檢測方面的經(jīng)驗；
• WHO has experience with testing services provided by the laboratory.
• 世界衛(wèi)生組織（WHO）在該實驗室提供的檢測服務(wù)方面的經(jīng)驗。
WHO reserves the right to proceed with the re-inspection of a WLQCL at anytime this is considered necessary based on information or complaints received by WHO. The NRA that has regulatory oversight over the laboratory will be invited to participate in the re-inspection as an observer.
世界衛(wèi)生組織（WHO）保留權(quán)利，基于其收到的信息或投訴，在認(rèn)為必要時隨時對世界衛(wèi)生組織認(rèn)證質(zhì)量控制實驗室（WLQCL）進(jìn)行重新檢查。對該實驗室負(fù)有監(jiān)管職責(zé)的國家監(jiān)管機(jī)構(gòu)（NRA）將被邀請作為觀察員參與重新檢查。
WHO may suspend or withdraw aWLQCL from the list of WHO-listed quality control laboratories when there is evidence of noncompliance with the WHO-recommended quality standards for such laboratories and/or this procedure.
若有證據(jù)表明世界衛(wèi)生組織認(rèn)證質(zhì)量控制實驗室（WLQCL）未遵守世界衛(wèi)生組織（WHO）針對此類實驗室推薦的質(zhì)量標(biāo)準(zhǔn)及 / 或本程序，WHO 可暫停其在 WHO 質(zhì)量控制實驗室清單中的資質(zhì)，或?qū)⑵鋸脑撉鍐沃谐?/span>
The re-evaluation of the WLQCL status of a QCL may not be prioritized if the laboratory has not, for a continuous period of more than three years, provided quality control services for pharmaceutical products to UN agencies, their partners, procurement agencies serving national authorities and UN agencies and/or national authorities of WHO Member States. In such cases, WHO will request the QCL to provide evidence that such services had been offered to, or commitments made to continue to offer such services, to UN agencies, their partners, procurement agencies serving national authorities and/or national authorities.
若質(zhì)量控制實驗室（QCL）連續(xù)三年以上未向聯(lián)合國機(jī)構(gòu)及其合作伙伴、為國家當(dāng)局和聯(lián)合國機(jī)構(gòu)服務(wù)的采購機(jī)構(gòu)，以及 / 或世界衛(wèi)生組織成員國國家當(dāng)局提供藥品質(zhì)量控制服務(wù)，則其世界衛(wèi)生組織認(rèn)證質(zhì)量控制實驗室（WLQCL）資格的重新評估可能不被優(yōu)先考慮。在此類情況下，WHO 將要求該 QCL 提供證據(jù)，證明其已向上述機(jī)構(gòu)提供此類服務(wù)，或作出承諾繼續(xù)向聯(lián)合國機(jī)構(gòu)及其合作伙伴、為國家當(dāng)局服務(wù)的采購機(jī)構(gòu)和 / 或國家當(dāng)局提供此類服務(wù)。
1.9 Monitoring of complaints1.9 投訴監(jiān)控
Complaints concerning the results of analysis of pharmaceutical products performed by the WLQCLor concerning the service provided by the WLQCL, which are communicated to WHO, will be investigated in accordance with an SOP established by WHO. The NRA that has regulatory oversight over the laboratory will be invited to participate in the investigation of the complaint.
若世界衛(wèi)生組織（WHO）收到針對世界衛(wèi)生組織認(rèn)證質(zhì)量控制實驗室（WLQCL）所執(zhí)行的藥品分析結(jié)果或其提供的服務(wù)的投訴，將根據(jù) WHO 制定的標(biāo)準(zhǔn)操作程序（SOP）開展調(diào)查。對該實驗室負(fù)有監(jiān)管職責(zé)的國家監(jiān)管機(jī)構(gòu)（NRA）將被邀請作為觀察員參與投訴調(diào)查。
After conducting its investigation, WHO will provide a written report of the problem, which may, where appropriate, include recommendations for action to the laboratory under investigation and to the NRA having the regulatory oversight over the laboratory.
世界衛(wèi)生組織（WHO）在完成調(diào)查后，將出具關(guān)于該問題的書面報告，適當(dāng)時可在報告中向受調(diào)查實驗室及對該實驗室負(fù)有監(jiān)管職責(zé)的國家監(jiān)管機(jī)構(gòu)（NRA）提出行動建議。
1.10 Cost recovery
WHO reserves the right to charge for the quality assessment procedure on a cost-recovery basis.
世界衛(wèi)生組織（WHO）保留基于成本回收原則對質(zhì)量評估程序收取費(fèi)用的權(quán)利。
1.11 Con?dentiality undertaking
1.11 保密承諾
WHO will require any external inspectors (acting as temporary advisers to WHO) to treat all information to which they gain access during the inspections of the laboratory, or otherwise in connection with the discharge of their responsibilities in regard to the WLQCL procedure, as con?dentialand proprietary to WHO or parties collaborating with WHO in accordance with the terms set out below.
世界衛(wèi)生組織（WHO）將要求所有外部檢查員（作為 WHO 的臨時顧問），將其在實驗室檢查期間獲取的所有信息，或在履行與 WLQCL 程序相關(guān)職責(zé)過程中以其他方式獲取的信息，視為 WHO 或與 WHO 合作方的機(jī)密和專有信息，并按照以下條款規(guī)定的條件進(jìn)行處理。
Such inspectors will be required to take all reasonable measures to ensure that con?dential information:
此類檢查員將被要求采取所有合理措施，以確保機(jī)密信息：
•is not used for any purpose other than the activities described in this document;
•僅用于本文件所述活動，不得作任何其他用途；
•is not disclosed or provided to any person who is not bound by similar obligations of con?dentiality and non-use as contained herein.
•不向未受本文件所載類似保密及非使用義務(wù)約束的任何人士披露或提供。
External inspectorswillnot,however,beboundbyanyobligationsofcon?dentialityandnon-useto the extent they are clearlyable todemonstrate thatanypartof thecon?dential information:
External inspectors will not, however, be bound by any obligations of con?dentiality and non-use to the extent they are clearly able to demonstrate that any part of the con?dential information:然而，外部檢查員在以下情形下不受保密及非使用義務(wù)的約束，且需明確證明相關(guān)機(jī)密信息的任何部分：
•was known to them prior to any disclosure by or on behalf of WHO (including by laboratories); or
•在世界衛(wèi)生組織（或其代表，包括實驗室）披露相關(guān)信息之前，該部分機(jī)密信息已為其所知；
•was in the public domain at the time of disclosure by or on behalf of WHO (including by laboratories); or
•在世界衛(wèi)生組織（或其代表，包括實驗室）披露相關(guān)信息時，該部分機(jī)密信息已屬于公開領(lǐng)域信息；
•has become part of the public domain through no fault of theirs; or
•然而，外部檢查員若能明確證明以下情形，則不受保密及非使用義務(wù)的約束：
•has become part of the public domain through no fault of theirs; or
•該部分機(jī)密信息因非自身過錯已進(jìn)入公開領(lǐng)域；
1.12 Conflict of interest
1.12 利益沖突
Before undertaking the work, each external inspector will also (in addition to the above-mentioned con?dentiality undertaking) be required to sign a declaration of interest. If, based on this declaration of interest, it is felt that there is no risk of arealor perceived con?ict of interest (or it is felt that there is only an insigni?cant and/or irrelevant con?ict of interest), and it is thus deemed appropriate for the inspector in question to undertake this work, he/she will discharge his/her functions exclusively as an adviser to WHO. In this connection, each inspector is required to con?rm that the information disclosed by him/her in the declaration of interest is correct and complete, and that he/she will immediately notify WHO of any change in this information.
在開展工作前，每位外部檢查員除需作出上述保密承諾外，還需簽署一份利益聲明。若基于該利益聲明，認(rèn)為不存在實際或潛在的利益沖突風(fēng)險（或僅存在微不足道和 / 或不相關(guān)的利益沖突），并因此認(rèn)定相關(guān)檢查員適合從事此項工作，則其應(yīng)僅以世界衛(wèi)生組織顧問的身份履行職責(zé)。就此，每位檢查員需確認(rèn)其在利益聲明中披露的信息準(zhǔn)確且完整，并承諾若該信息發(fā)生任何變化，將立即通知世界衛(wèi)生組織。
All external inspectors furthermore agree that, at the laboratory’s request, WHO will advise the laboratory in advance of the identity of each inspector and the composition of the team performing the site inspection and provide curricula vitae of the external inspectors. The laboratory then has the opportunity to express possible concerns regarding any of the external inspectors to WHO prior to the visit. If such concerns cannot be resolved in consultation with WHO, the laboratory may object to an external inspector’s participation in the site visit. Such an objection must be made known to WHO by the laboratory within 10 days of being notified of the proposed team composition. In the event of such an objection, WHO reserves the right to cancel its agreement with the inspector in question and the activities to be undertaken by that inspector, in whole or in part.
此外，所有外部檢查員同意：若實驗室提出請求，世界衛(wèi)生組織（WHO）將提前告知實驗室每位檢查員的身份、現(xiàn)場檢查團(tuán)隊的組成，并提供外部檢查員的簡歷。隨后，實驗室有權(quán)在檢查前就任何外部檢查員向 WHO 提出可能的疑慮。若相關(guān)疑慮無法通過與 WHO 協(xié)商解決，實驗室可反對某一外部檢查員參與現(xiàn)場檢查。此類反對意見須在實驗室收到擬議團(tuán)隊組成通知后的 10 天內(nèi)告知 WHO。若出現(xiàn)該類反對情況，WHO 保留取消與相關(guān)檢查員的協(xié)議及該檢查員全部或部分工作內(nèi)容的權(quán)利。
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