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导读：近日,世界卫生组织（WHO）发布 质量控制实验室原则上可接受性评估程序的草案，阐述了WHO列名 质量控制实验室符合WHO《药品质量控制实验室良好规范》（GPPQCL）、《药品微生物实验室良好规范》以及《药品生产质量管理规范》（GMP）的相关部分和 WHO《国家监管机构质量管理体系实施指南》（NRA 的 QMS）的评估程序：
近日,世界卫生组织（WHO）发布 质量控制实验室原则上可接受性评估程序的草案，阐述了WHO列名 质量控制实验室符合WHO《药品质量控制实验室良好规范》（GPPQCL）、《药品微生物实验室良好规范》以及《药品生产质量管理规范》（GMP）的相关部分和 WHO《国家监管机构质量管理体系实施指南》（NRA 的 QMS）的评估程序：
以下为原文及其翻译
WHO listing of quality control laboratories:procedure for assessing the acceptability, inprinciple, of quality control laboratories for use by United Nations agencies .
世界卫生组织（WHO）质量控制实验室列名：联合国机构所用质量控制实验室原则性可接受性评估程序
Table of contents
目录
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 Confidentiality undertaking
1.12 Conflict of interest
程序步骤
1.1 发布意向征集公告
1.2 提交意向书及实验室信息
1.3 筛选提交的实验室信息
1.4 评估实验室信息
1.5 实地考察
1.6 考察报告及结果
1.7 评估结果
1.8 对世界卫生组织合作中心实验室（WLQCLs）的监测
1.9 对投诉的监测
1.10 成本回收
1.11 保密承诺
1.12 利益冲突
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.
本文件是对最初作为世界卫生组织（WHO）《技术报告系列》（TRS）第 961 号（2011 年）附件 12 发布，并在 WHO《技术报告系列》第 1003 号（2017 年）附件 3 中首次更新的程序的最新修订。应要求，WHO 向联合国（UN）各机构、其合作伙伴、为国家当局和联合国机构服务的采购机构以及 WHO 会员国的国家当局，就被认定符合 WHO 为此类实验室推荐的质量标准的质量控制实验室（QCLs）在原则上的可接受性提供建议。这些标准载于《药品质量控制实验室良好规范》（GPPQCL）（1），并在适用情况下包括《药品微生物实验室良好规范》（2），以及《药品生产质量管理规范》（GMP）（3）的相关部分和 WHO《国家监管机构质量管理体系实施指南》（NRA 的 QMS）（4）。这是通过标准化的质量评估程序完成的。质量评估程序的目的是评估用于药品质量控制的 QCLs 是否符合 WHO 为此类实验室推荐的要求。
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.
参与被指定为WHO列名质量控制实验室（WLQCL）的程序是自愿的，任何为联合国机构、其合作伙伴、为国家当局和联合国机构服务的采购机构以及 / 或世界卫生组织会员国的国家当局提供药品质量控制服务的药品质量控制实验室（政府或私人性质）均有资格参与。
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.
鼓励通过认证（如符合 ISO/IEC17025 标准的 ISO 认证），且该认证也会在指定为 WLQCL 的程序中予以考虑。建议实验室致力于获得认证。此外，对于官方（政府）质量控制实验室，WLQCL 列名要求该实验室所属的监管体系通过 WHO 全球基准工具（GBT）（5）评估，在实验室职能方面达到成熟度 3 级。更广泛地说，鼓励负责国家医疗产品总体监管体系的监管机构在所有监管职能方面努力达到成熟度 3 级。
The assessment procedure established by WHO is based on the following principles:
世界卫生组织制定的评估程序基于以下原则：
•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;
•实验室提供或承诺为联合国机构及其合作伙伴、为国家当局和联合国机构服务的采购机构以及 / 或世界卫生组织会员国的国家当局提供药品质量控制服务的证据；
•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;
•对实验室文件化质量管理体系和质量控制检测活动的总体了解，包括对《国际药典》及其他公认药典的使用；
•evaluation of information submitted by the laboratory
•对实验室提交信息的评估；
•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);
•对符合世界卫生组织推荐的质量控制实验室（QCLs）质量标准（即《药品质量控制实验室良好规范》（GPPQCL，编号 1））的合规性评估，适用时包括《药品微生物实验室良好规范》（编号 2），以及《药品生产质量管理规范》（GMP，编号 3）和《国家监管机构质量管理体系实施指南》（编号 4）的相关部分；
•monitoring of performance of WLQCLs and their compliance with WHO requirements.
•对世界卫生组织列名质量控制实验室（WLQCLs）的性能及其遵守世卫组织要求的情况进行监测。
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 official medicines control laboratories network) of their submission for designation as a WLQCL.
世卫组织邀请对参与 WLQCL 程序的实验室具有监管监督权的国家监管机构（NRA）作为观察员参与实验室是否符合世卫组织推荐的 QCL 标准的检查。世卫组织建议，有兴趣参与 WLQCL 程序的实验室应将其申请指定为 WLQCL 的事宜通知其所在国家的监管机构以及相关网络（例如，欧洲官方药品控制实验室通用网络）。
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.
本程序适用于将质量控制实验室（QCLs）列入世界卫生组织清单（WLQCL），以供联合国机构及其合作伙伴、为国家当局和联合国机构服务的采购机构以及 / 或世界卫生组织会员国的国家当局使用。
1. Steps of the procedure
1. 程序步骤
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评估的实验室提供与其活动及药品质量控制相关的信息。感兴趣的 QCLs 应按 WHO 要求（见下文 1.2 点）提交其活动信息。除了评估提交的信息外，还可能进行一次或多次现场检查。
If, due to insufficient 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.
如果由于资源不足和时间限制，WHO 必须在评估感兴趣的实验室时确定优先顺序，那么将优先考虑联合国机构及其合作伙伴、为国家当局和联合国机构服务的采购机构，以及 WHO 成员国的国家当局确定有药品质量检测需求地区的 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.
属于或附属于药品制造商的实验室提交的申请，尤其是那些希望其一种或多种产品获得 WHO 预认证，或其产品已获得 WHO 预认证的实验室，其申请可能会被给予较低优先级，甚至可能不予评估。
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 specified time period.
如果实验室无法提供或未能提供所需信息，提供的信息不足以有效完成质量评估，以及实验室未能配合 WHO 要求的检查，和 / 或未能在规定时间内实施 WHO 可能要求的纠正措施，WHO 保留终止对该实验室质量评估的权利。
1.1 Publication of invitation for Expressions of Interest
1.1 发布意向征集邀请
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 将发布邀请，邀请 QCLs 提交参与 WLQCL 程序的意向书（EOI）。该邀请将明确受 WLQCL 清单约束的质量控制检测范围，并将广泛发布，即在 WHO 网站上发布，也可能通过其他媒体，如国际新闻媒体发布。邀请将公开透明，邀请所有感兴趣的 QCLs 提交列入 WLQCL 清单的 EOI。
1.2 Submission of EOIs and laboratory information
1.2 提交意向书及实验室信息
Each interested laboratory should provide the WHO focal point indicated in the invitation for EOIs with:
各有意向的实验室应按意向书邀请中注明的方式，向世界卫生组织（WHO）联络点提供以下内容：
• 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.
• 一封表明有兴趣参与世界卫生组织药品质量控制实验室程序（WLQCL）的求职信；
• 证据证明实验室已向或承诺向联合国机构及其合作伙伴、为国家当局和联合国机构提供服务的采购机构，以及（或）世界卫生组织成员国的国家当局提供药品质量控制服务；• 相关实验室信息。
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 file (LIF) (see below) that is not provided in the quality manual.
世卫组织将把每个实验室提交的意向书收讫情况记录在登记册中。若实验室已通过质量手册对其质量体系进行了文件化说明，则可提交该手册，但需补充质量手册中未包含的实验室信息档案（LIF）所需信息（见下文）。
The information should be submitted as described in the document Guidelines for preparing a laboratory information file (6) and cover the areas listed below, which are based on and complement the content of the Guidelines:
相关信息应按照《实验室信息档案编制指南》（6）文件中的说明提交，并涵盖以下所列领域，这些领域基于该指南的内容并对其进行补充：
general information on the laboratory, including activities proposed for WLQCL listing;
实验室的基本信息，包括拟列入世界卫生组织药品质量控制实验室程序（WLQCL）的活动清单；
riskmanagement
风险管理
performancemanagement;
绩效管理
crisis management
危机管理
communication management
沟通管理
participation in proficiency testing schemes and/or collaborative trials;
参与能力验证计划和 / 或协作试验
internal audits
内部审计
control of data, documentation and records;
数据、文件和记录的控制
personnel
人员
premises
场所
equipment
设备
reagents, reference substances and reference materials;
试剂、参考物质和标准物质
subcontracting of testing (where applicable);
检测分包（如适用）；
handling of samples;
样品处理
validation and verification of analytical procedures;
分析程序的验证和确认
evaluation and reporting of results;
结果的评估与报告；
investigation of out-of-specification (OOS) results;
超标（OOS）结果的调查
uncertainty of measurement;
测量不确定度
stability testing (where applicable)
稳定性测试（如适用）
microbiological testing (where applicable);
微生物检测（如适用）
testing of vaccines (where applicable);
疫苗检测（如适用）
testing of biologicals and advanced therapy medicinal products (where applicable) .
生物制品和先进治疗药品的检测（如适用）。
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.
关于提交意向书（EOI）以及相关信息的准备和提交指南，可在世卫组织网站（http://apps.who.int/prequal/）上获取，也可根据申请向感兴趣的实验室发送。
1.3 Screening of submitted laboratory information
1.3 所提交实验室信息的筛选
The Guidelines for preparing alaboratoryinformation file(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.
实验室信息文件编制指南（6）将用于对所提供信息的初步筛选。若信息不完整，将不予评估。在此情况下，将要求实验室在指定时间内提供补充信息。若未在截止日期前收到补充信息，申请将被驳回。
1.4 Evaluation of the laboratory information
1.4 实验室信息评估
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 节规定要求的实验室信息，将根据世界卫生组织（WHO）制定的标准操作规程（SOP）进行评估，以确保信息评估的一致性。该信息将对照 WHO 为合格评定实验室（QCLs）推荐的质量标准进行评估，即《药品质量控制实验室良好实践》（GPPQCL，参考文献 1），包括适用情况下的《制药微生物学实验室良好实践》（参考文献 2），以及《药品生产质量管理规范》（GMP，参考文献 3）和《国家监管机构质量管理体系实施指南》（参考文献 4）的相关部分。实验室可能会被考虑进行现场检查。
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.
实验室可提交由监管机构依据至少等同于世界卫生组织（WHO）为合格评定实验室（QCLs）推荐的质量标准 [即《药品质量控制实验室良好实践》（GPPQCL，参考文献 1），包括适用情况下的《制药微生物学实验室良好实践》（参考文献 2）、《药品生产质量管理规范》（GMP，参考文献 3）相关部分，以及《国家监管机构质量管理体系实施指南》（参考文献 4）相关部分] 开展的检查或审计报告，连同实验室针对监管机构在检查或审计过程中提出的意见所作的回应。
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.
根据世界卫生组织（WHO）制定的外部检查和审计审查标准操作规程（SOP），若实验室被认定在符合 WHO 推荐标准方面达到可接受的合规水平，WHO 可能会决定无需进行现场检查。
1.5 Site inspection
1.5 现场检查
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 qualifications and experience in the field of quality control of pharmaceutical products.
根据对实验室信息的评估结果，世界卫生组织（WHO）可能会规划并协调对实验室的检查，以评估其是否符合 WHO 为这类实验室推荐的质量标准，即《药品质量控制实验室良好实践》（GPPQCL，参考文献 1），包括适用情况下的《制药微生物学实验室良好实践》（参考文献 2），以及《药品生产质量管理规范》（GMP，参考文献 3）和《国家监管机构质量管理体系实施指南》（参考文献 4）的相关部分。检查工作将由具备药品质量控制领域相关资质和经验的一名或一组检查员执行。
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 confidentiality and conflict 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 findings in accordance with SOPs established by WHO to ensure a standard harmonized approach.
外部检查员将根据世卫组织（WHO）程序任命，并担任世卫组织的临时顾问。外部检查员必须遵守本程序相关章节规定的世卫组织保密和利益冲突规则。世卫组织工作人员将对检查小组进行协调。检查员或检查小组将按照世卫组织制定的标准操作规程（SOP）开展检查并报告检查结果，以确保采用统一的标准方法。
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.
对参与世界卫生组织合格评定实验室（WLQCL）程序的实验室负有监管职责的国家监管机构（NRA），其一名或多名代表将被邀请作为观察员随同检查小组参与检查。
With a view to coordinating inspection activities, avoiding duplication and promoting information sharing without prejudice to the protection of any confidential 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.
为协调检查活动、避免重复工作并促进信息共享，同时根据本程序条款保护实验室的任何机密和专有信息，世界卫生组织（WHO）可向其成员国监管机构、联合国机构以及欧洲药品和保健质量局披露与检查相关的信息。
1.6 Report and outcome of inspection
1.6 检查报告与结果
The inspector or inspection team will finalize a report describing the findings 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.
检查员或检查小组将根据世卫组织（WHO）既定的标准操作规程（SOP）和格式，完成一份描述检查结果的报告。世卫组织将把该报告传达给实验室，并向对该实验室负有监管职责的国家监管机构（NRA）发送副本。
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.
若需要补充信息，或实验室必须采取纠正措施，世卫组织（WHO）将暂缓对相关实验室是否合格的决定，直至补充信息评估完毕或纠正措施已落实且结果令人满意。若根据所收到的信息仍无法作出决定，则将进行后续检查。
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.
若实验室与世界卫生组织（WHO）之间出现任何分歧，应遵循处理此类分歧的标准操作规程（SOP）来讨论并解决相关问题。
As WHO is responsible for the quality assessment procedure, the ownership of the reports lies with WHO (without prejudice, however, to any confidentialand 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 confidential and proprietary information of the laboratory. “Confidential information” in this context means:
由于世界卫生组织（WHO）负责质量评估程序，报告的所有权归 WHO 所有（但不影响报告中包含的实验室任何机密和专有信息）。因此，WHO 有权使用和发布此类报告，但始终需保护实验室的任何机密和专有信息。此处 “机密信息” 指：
• confidential intellectual property, “know-how” and trade secrets (including, for example, programmes, processes or methods, unpublished aspects of trademarks and patents); • commercial confidences (for example, structures and development plans).
•机密知识产权、“专有技术” 和商业秘密（包括例如程序、工艺或方法，以及未公开的商标和专利内容）；•商业机密（例如企业架构和发展规划）。
Provisions of confidentiality 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.
世界卫生组织（WHO）与实验室之间往来的信函中将包含保密条款，这些条款需在信息评估和现场检查前达成一致。
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.
尽管有上述规定，世界卫生组织（WHO）仍保留向本组织任何相关成员国的主管部门及相关联合国机构分享完整报告的权利。
1.7 Results of assessment
1.7 评估结果
Once WHO is satisfied 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 specified site will be included in a list referred to as “List of WHO-listed quality control laboratories” .
一旦世界卫生组织（WHO）确认该实验室的质量评估流程已完成，且原则上认可其可供联合国机构及其合作伙伴、为国家当局和联合国机构服务的采购机构，以及 / 或 WHO 成员国的国家当局使用（即认定其符合 WHO 为质量控制实验室推荐的质量标准），该指定地点的实验室将被列入 “WHO 认证质量控制实验室清单”。
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).
清单上的实验室将被视为有能力按照世界卫生组织（WHO）为质量控制实验室（QCLs）推荐的质量标准对产品进行检测。然而，列入该清单并不意味着 WHO 对这些实验室的任何认可（此乃国家当局的专属职权）。
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.
在其名称公布于世界卫生组织认证质量控制实验室清单（WLQCLs）之前，每个实验室将收到世卫组织的信函，告知其专项质量评估流程的结果。
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.
此信函的副本将被发送至实验室所在国家的国家监管机构（NRA）。世界卫生组织认证质量控制实验室清单（WLQCLs）将公布于世卫组织官网，并详细列明所评估的专业领域及被认定纳入清单的领域。该清单将在获取新的相关信息时及时更新。
In accordance with World Health Assembly Resolution WHA57.14 of 22 May 2004, WHO will – subject to the protection of any confidential 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.
根据 2004 年 5 月 22 日世界卫生大会第 WHA57.14 号决议，世界卫生组织（WHO）将在保护所有机密及专有信息的前提下，公布针对被认定符合 WHO 为质量控制实验室（QCLs）推荐的质量标准的实验室的公开检查报告。这些报告将在世卫组织官网发布。
1.8 Monitoring of WLQCLs
1.8 世界卫生组织认证质量控制实验室（WLQCLs）的监管
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.
一旦实验室被列入世界卫生组织认证质量控制实验室清单（WLQCLs），应立即通知世卫组织任何可能影响其清单资质的变更情况（如设施、设备或关键人员变动），并提交更新后的实验室信息表（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.
每个世界卫生组织认证质量控制实验室（WLQCLs）均需定期（每年）重新评估；若世卫组织获取到表明有必要重新评估的信息，则可提前进行评估。
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:
为使世界卫生组织（WHO）能够开展重新评估，所有世界卫生组织认证质量控制实验室（WLQCLs）需提交其活动的年度简要报告。该报告应涵盖过去三年与药品质量控制相关的全部活动，并应于次年 3 月底前提交。报告应包含以下内容：
•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;
•向联合国机构及其合作伙伴、为国家当局和联合国机构服务的采购机构，以及 / 或世界卫生组织成员国国家当局提供服务的概述；
•a summary of number of samples analysed, differentiating between compliant and noncompliant samples including anyOOS/out-of-trend investigations;
•分析样品数量的概述，区分合规与不合规样品，包括任何超标（OOS）/ 趋势外调查；
•a list of analytical methods used, including testing parameters and reference documents、
•所用分析方法的清单，包括检测参数和参考文件；
•a summary of complaints received from customers concerning results of analyses performed by the laboratory;
•实验室收到的客户关于分析结果的投诉概述；
•brief details of participation in proficiency testing schemes (organizing party, methods involved,outcomes and, if appropriate, corrective measures adopted);
•参加能力验证计划的简要详情（组织方、涉及的方法、结果，以及适当情况下采取的纠正措施）；
•listing of inspections and audits performed by external parties, identifying the party and the scope of the inspection and audit;
•外部机构开展的检查和审计清单，列明机构名称及检查审计范围；
•confirmation of the primary and secondary contact points;
•主要和次要联络点的确认信息；
•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.
•若已实施对实验室信息表（LIF）内容有影响的变更，报告中应包含这些变更的概述，并附上更新后的 LIF。
•WHO will conduct re-inspections of WLQCLs in accordance with SOPs established by WHO
.•世界卫生组织（WHO）将根据其制定的标准操作程序（SOPs）对世界卫生组织认证质量控制实验室（WLQCLs）进行重新检查。
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:
此类重新检查的频率取决于世界卫生组织（WHO）对下述质量风险管理因素的评估。不过，通常情况下，此类重新检查至少每三年进行一次。规划检查时将考虑以下因素：
• major changes, for example, to premises, equipment or key personnel;
• 重大变更，例如场所、设备或关键人员的变更；
• 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;
• 世界卫生组织（WHO）或其他外部机构先前检查 / 审计的结果，以及实验室遵守 WHO 推荐质量标准的历史记录；
• the outcomes of participation of the laboratory in proficiency testing schemes;
• 实验室参加能力验证计划的结果；
• number and significance of complaints made known to the QCL by customers;
• 客户向质量控制实验室（QCL）反馈的投诉数量及其重要性；
• laboratory experience with testing of pharmaceutical products
• 实验室在药品检测方面的经验；
• WHO has experience with testing services provided by the laboratory.
• 世界卫生组织（WHO）在该实验室提供的检测服务方面的经验。
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.
世界卫生组织（WHO）保留权利，基于其收到的信息或投诉，在认为必要时随时对世界卫生组织认证质量控制实验室（WLQCL）进行重新检查。对该实验室负有监管职责的国家监管机构（NRA）将被邀请作为观察员参与重新检查。
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.
若有证据表明世界卫生组织认证质量控制实验室（WLQCL）未遵守世界卫生组织（WHO）针对此类实验室推荐的质量标准及 / 或本程序，WHO 可暂停其在 WHO 质量控制实验室清单中的资质，或将其从该清单中除名。
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.
若质量控制实验室（QCL）连续三年以上未向联合国机构及其合作伙伴、为国家当局和联合国机构服务的采购机构，以及 / 或世界卫生组织成员国国家当局提供药品质量控制服务，则其世界卫生组织认证质量控制实验室（WLQCL）资格的重新评估可能不被优先考虑。在此类情况下，WHO 将要求该 QCL 提供证据，证明其已向上述机构提供此类服务，或作出承诺继续向联合国机构及其合作伙伴、为国家当局服务的采购机构和 / 或国家当局提供此类服务。
1.9 Monitoring of complaints1.9 投诉监控
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.
若世界卫生组织（WHO）收到针对世界卫生组织认证质量控制实验室（WLQCL）所执行的药品分析结果或其提供的服务的投诉，将根据 WHO 制定的标准操作程序（SOP）开展调查。对该实验室负有监管职责的国家监管机构（NRA）将被邀请作为观察员参与投诉调查。
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.
世界卫生组织（WHO）在完成调查后，将出具关于该问题的书面报告，适当时可在报告中向受调查实验室及对该实验室负有监管职责的国家监管机构（NRA）提出行动建议。
1.10 Cost recovery
WHO reserves the right to charge for the quality assessment procedure on a cost-recovery basis.
世界卫生组织（WHO）保留基于成本回收原则对质量评估程序收取费用的权利。
1.11 Confidentiality undertaking
1.11 保密承诺
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 confidentialand proprietary to WHO or parties collaborating with WHO in accordance with the terms set out below.
世界卫生组织（WHO）将要求所有外部检查员（作为 WHO 的临时顾问），将其在实验室检查期间获取的所有信息，或在履行与 WLQCL 程序相关职责过程中以其他方式获取的信息，视为 WHO 或与 WHO 合作方的机密和专有信息，并按照以下条款规定的条件进行处理。
Such inspectors will be required to take all reasonable measures to ensure that confidential information:
此类检查员将被要求采取所有合理措施，以确保机密信息：
•is not used for any purpose other than the activities described in this document;
•仅用于本文件所述活动，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 confidentiality and non-use as contained herein.
•不向未受本文件所载类似保密及非使用义务约束的任何人士披露或提供。
External inspectorswillnot,however,beboundbyanyobligationsofconfidentialityandnon-useto the extent they are clearlyable todemonstrate thatanypartof theconfidential information:
External inspectors will not, however, be bound by any obligations of confidentiality and non-use to the extent they are clearly able to demonstrate that any part of the confidential information:然而，外部检查员在以下情形下不受保密及非使用义务的约束，且需明确证明相关机密信息的任何部分：
•was known to them prior to any disclosure by or on behalf of WHO (including by laboratories); or
•在世界卫生组织（或其代表，包括实验室）披露相关信息之前，该部分机密信息已为其所知；
•was in the public domain at the time of disclosure by or on behalf of WHO (including by laboratories); or
•在世界卫生组织（或其代表，包括实验室）披露相关信息时，该部分机密信息已属于公开领域信息；
•has become part of the public domain through no fault of theirs; or
•然而，外部检查员若能明确证明以下情形，则不受保密及非使用义务的约束：
•has become part of the public domain through no fault of theirs; or
•该部分机密信息因非自身过错已进入公开领域；
1.12 Conflict of interest
1.12 利益冲突
Before undertaking the work, each external inspector will also (in addition to the above-mentioned confidentiality 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 conflict of interest (or it is felt that there is only an insignificant and/or irrelevant conflict 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 confirm 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.
在开展工作前，每位外部检查员除需作出上述保密承诺外，还需签署一份利益声明。若基于该利益声明，认为不存在实际或潜在的利益冲突风险（或仅存在微不足道和 / 或不相关的利益冲突），并因此认定相关检查员适合从事此项工作，则其应仅以世界卫生组织顾问的身份履行职责。就此，每位检查员需确认其在利益声明中披露的信息准确且完整，并承诺若该信息发生任何变化，将立即通知世界卫生组织。
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，所有外部检查员同意：若实验室提出请求，世界卫生组织（WHO）将提前告知实验室每位检查员的身份、现场检查团队的组成，并提供外部检查员的简历。随后，实验室有权在检查前就任何外部检查员向 WHO 提出可能的疑虑。若相关疑虑无法通过与 WHO 协商解决，实验室可反对某一外部检查员参与现场检查。此类反对意见须在实验室收到拟议团队组成通知后的 10 天内告知 WHO。若出现该类反对情况，WHO 保留取消与相关检查员的协议及该检查员全部或部分工作内容的权利。
来源：Internet
关键词： 实验室
