WHO 发布 TRS 1067 附录5：质量控制实验室列名程序（第二次修订）
TRS 1067 - Annex 5: WHO listing of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies
WHO 在 TRS 1067 附录5 发布质量控制实验室列名程序，将原“预认证”名称改为 WHO 列名（WLQCL）。该文件是 TRS No. 961（2011）附录12 的第二次修订，首次修订见 TRS No. 1003（2017）附录3。
该程序将实验室预认证更名为WHO列名，并列出信息提交、评估、现场审计与年度复查等环节，可供实验室对照准备材料。
译文尚不完整，完整内容请切换到原文。
WHO 正式技术报告附录：TRS 1067 - 附录 5：WHO 质量控制实验室列名：评估联合国机构使用的质量控制实验室原则上可接受性的程序
官方目录发布日期：2026-06-09（原文 9 June 2026）；报告年份、会议日期及适用范围请以文件正文为准。
官方出版页：https://www.who.int/publications/m/item/trs-1067---annex-5--who-listing-of-quality-control-laboratories--procedure-for-assessing-the-acceptability--in-principle--of-quality-control-laboratories-for-use-by-united-nations-agencies
PDF 文字版；图形和原始排版请参阅官方 PDF。
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附件5
WHO 质量控制实验室列名：评估联合国机构拟用质量控制实验室在原则上可接受性的程序
质量控制实验室预认证更新：评估联合国机构拟用质量控制实验室在原则上可接受性的程序，WHO 技术报告系列第1003号，2017年，附件3。
如需任何进一步信息或提出请求，请发送电子邮件至 WHO 药品标准与规范（NSP）团队，邮箱：[email protected]。
目录
缩略语 170
1. 引言 170
2. 程序步骤 172
2.1 发布意向征询邀请 172
2.2 提交意向书和实验室信息 173
2.3 对提交的实验室信息进行筛选 174
2.4 评估实验室信息 174
2.5 现场审计 175
2.6 审计报告和结果 175
2.7 评估结果 176
2.8 对 WLQCL 的监测 177
2.9 投诉监测 178
2.10 成本回收 179
2.11 保密承诺 179
2.12 利益冲突 179
参考文献 181
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WHO 药物制剂规格专家委员会 第五十九次报告
缩写
QCL 质量控制实验室
WHO 世界卫生组织
WLA WHO 列名机构
WLQCL WHO 列名质量控制实验室
1. 引言
本文件是对最初作为附件 12 发表于《世界卫生组织（WHO）技术报告系列第 961 号，2011 年》的程序的第二次修订，该程序首次修订于《WHO 技术报告系列第 1003 号，2017 年》附件 3。在本次第二次修订中，原称为“质量控制实验室资格预审”的程序现更名为“WHO 质量控制实验室列名”，以确保与 WHO 更广泛的监管术语和列名机制（如 WHO 列名机构（WLA））保持一致。与以产品为中心的资格预审不同，列名模式更好地反映了实验室作为服务提供者的角色，认可了已在 WLA 框架下开展的评估，并减少了重复评估。
WHO 应请求向联合国机构及其合作伙伴、WHO 成员国的国家主管机构，以及为国家主管机构和联合国机构提供服务的采购机构，提供关于质量控制实验室（QCL）原则上可接受性的建议，前提是这些实验室被认定符合 WHO 为此类实验室推荐的质量标准。这些标准载于 WHO 药物质量控制实验室良好规范
WHO 技术报告系列，第 1067 号，2026 年
（1），并在适用时包括药物微生物学实验室良好规范（2），以及药品生产质量管理规范（3）的相关部分和 WHO 关于国家监管机构质量管理体系实施指南（4）的相关部分。这是通过标准化评估程序完成的。评估程序的目的是评价拟用于药品质量控制的质量控制实验室是否符合 WHO 为此类实验室推荐的要求。
参与 WHO 列名质量控制实验室（WLQCL）指定程序是自愿的，任何为联合国机构及其合作伙伴、WHO 成员国的国家主管机构，以及为国家主管机构和联合国机构提供服务的采购机构提供药品质量控制服务的药品质量控制实验室（政府或私营）均有资格参与。
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鼓励进行认可，例如依据 ISO/IEC 17025 进行的认可。虽然认可并非强制性前提条件，但建议实验室努力获得认可，因为认可表明质量管理体系已得到实施，并有助于其推进 WHO 列名程序。此外，认可涉及定期监督和重新评估，这有助于实验室质量管理的可持续性并推动持续改进，而这两者也是 WLQCL 框架下的要求，因此有利于维持 WHO 列名状态。
此外，对于官方（政府）质量控制实验室，WLQCL 列名要求实验室所属的监管体系在实验室职能方面达到成熟度 3 级，该等级通过 WHO 全球基准评估工具进行评估（5）。更广泛而言，鼓励监管机构作为国家医疗产品监管体系中的牵头机构，在所有监管职能方面努力达到成熟度 3 级。
WHO 建立的评估程序基于以下原则：
■ 有证据表明该实验室向联合国机构及其合作伙伴、WHO 成员国的国家主管当局，以及为国家主管当局和联合国机构提供服务的采购机构，提供或承诺提供药品质量控制服务；
■ 全面了解实验室成文的质量管理体系和检测活动，包括使用公认的药典（例如《国际药典》）；
■ 对提交的文件进行评估；
■ 符合 WHO 推荐的 QCL 质量标准，即药品质量控制实验室良好规范（1），包括在适用情况下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（3）和 WHO 国家监管机构质量管理体系实施指南（4）的相关部分；
■ 对 WLQCL 的绩效及其对 WHO 要求的符合情况进行监测。
WHO 邀请对参与 WLQCL 程序的实验室负有监管监督职责的国家监管机构作为……加入 171
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WHO 药物制剂规格专家委员会第五十九次报告
作为观察员参与对实验室符合 WHO 推荐的
QCL 标准的审计。WHO 建议，有意
参与 WLQCL 程序的实验室，应告知其所在
国家的监管机构以及相关网络（例如，
欧洲官方药品检验实验室网络），其
提交指定为 WLQCL 的申请。
2. 程序步骤
WHO 要求提供有意在本程序下接受评估的实验室的
活动及药品质量控制相关信息。
有意向的 QCL 应按 WHO 的要求（见下文第 2.2 点）提交
其活动信息。除对所提交信息进行评估外，
还可能进行一次或多次现场审计。
如果由于资源不足和时间限制，WHO 必须
在对有意向的实验室进行评估时确定优先次序，则将优先考虑
位于联合国机构及其合作伙伴、WHO 成员国国家
主管机构，以及为国家主管机构和联合国机构服务的采购机构
确定需要开展药品质量检验的地区的 QCL。
来自隶属于或附属于药品生产商的实验室的
申请，尤其是那些有意使其一种或多种产品通过 WHO
预认证或其产品已通过 WHO 预认证的实验室，
可能被给予较低的优先次序，或者可能完全
不予评估。
WHO 保留在以下情况下终止对实验室质量评估的权利：
（a）实验室无法提供或未能提供所需
信息；（b）所提供的信息不足以有效完成
质量评估；（c）实验室未能或拒绝在
WHO 技术报告系列，No. 1067，2026
WHO 审计期间予以配合；或（d）实验室无法在
规定期限内实施 WHO 可能要求的纠正
措施。
2.1 发布意向征询邀请
WHO 将发布邀请，请 QCL 提交参与
WLQCL 程序的意向书。该邀请将明确
须进行 WLQCL 列名的质量控制检验范围，并将
广泛发布，即在 WHO 网站上，也可能通过其他媒体，例如
国际新闻界。该邀请将公开透明，邀请所有
有意向的 QCL 提交 WLQCL 列名意向书。
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2.2 提交意向书
和实验室信息
每个有意向的实验室应向意向书邀请函中指定的 WHO 联络点提供：
■ 一封表明有意参与 WLQCL
程序的附函；
■ 证明该实验室提供或承诺提供
面向联合国机构及其合作伙伴、WHO
成员国的国家主管当局，以及服务于国家
主管当局和联合国机构的采购机构的
药品质量控制服务的证据；
■ 相关实验室信息。
WHO 将在登记册中记录收到每个
实验室的意向书。如果实验室已将其质量体系记录为
质量手册，则可以提交，前提是补充提供
实验室信息档案（见下文）所需但
质量手册中未提供的信息。
信息应按照 WHO《编制实验室信息档案
指南》(6) 所述提交，并应涵盖下列
领域，这些领域基于该指南的内容并对其加以补充：
■ 实验室的一般信息，包括拟
列入 WLQCL 的活动，以及适用时与
疫苗、生物制品或先进治疗药品
检测相关的活动；
■ 认可或认证状态（如适用）；
■ 已实施的质量管理体系，以及实验室
所接受的检查与外部审计；
■ 风险管理；
■ 绩效管理；
■ 危机管理；
■ 沟通管理；
■ 参加能力验证计划或协作试验；
■ 内部审计；
■ 数据、文件和记录的控制；
■ 人员；
■ 厂房设施；
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WHO 药物制剂规格专家委员会第五十九次报告
■ 具有确认程序的设备；
■ 试剂、标准物质和参考物质；
■ 检测的分包（适用时）；
■ 样品的处理；
■ 分析方法的验证与确认；
■ 结果的评价与报告；
■ 非典型结果（超出质量标准、超出趋势或
超出预期结果）的调查；
■ 测量不确定度；
■ 稳定性试验（适用时）；
■ 微生物学检验（适用时）。
关于提交意向书以及编写和提交相关信息的
指南可在 WHO 网站上获取，并将在收到请求时发送给
感兴趣的实验室。
2.3 对提交的实验室信息的筛选
将使用 WHO《实验室信息文件编写指南》(6) 对所提供的
信息进行初步筛选。如果信息不完整，将不予
评价。在此类情况下，将要求实验室在
规定时间内提供补充信息。如果未在截止日期前
收到补充信息，申请将被拒绝。
2.4 对实验室信息的评价
符合第 2.2 节所列要求的实验室信息
将按照 WHO 为确保信息评价一致性而制定的
WHO 技术报告系列，No. 1067, 2026
标准操作规程进行评价。将依据 WHO 推荐的
QCL 质量标准对该信息进行评价，即药品质量控制实验室
良好规范 (1)，包括在适用情况下药品微生物学
实验室良好规范 (2)，以及药品生产质量管理规范
(3) 的相关部分和 WHO 关于国家监管机构实施质量管理
体系指南 (4) 的相关部分。评价结果应
决定该实验室是否会被考虑进行可能的现场审计。
实验室可提交由监管机构实施的检查报告，
或由认可机构或其他主管机构实施的审计报告，
连同实验室对任何观察项的回应。
这些检查或审计应按照至少等同于上述
所概述标准的标准进行。
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Annex 5
Based on a standard operating procedure 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 audit.
2.5 Site audit
Depending on the outcome of the evaluation of the laboratory information, WHO
may plan and coordinate audits of the laboratory to assess compliance with the
applicable WHO-recommended quality standards described above.8 The audit will
be performed by an auditor, or a team of auditors, having the relevant qualifications
and experience in the field of quality control of pharmaceutical products.
External auditors will be appointed in accordance with WHO procedures
and will act as temporary advisers to WHO. The external auditors 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 auditor or audit team will perform the audits and report on the
findings in accordance with standard operating procedures established by WHO
to ensure a standard harmonized approach.
A representative or representatives of the national regulatory authority
having regulatory oversight over a laboratory participating in the WLQCL
procedure will be invited to accompany the team as an observer.
With a view to coordinating audit 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 audit-related information to
regulatory authorities of WHO Member States, United Nations agencies and the
European Directorate for the Quality of Medicines and HealthCare.
2.6 Report and outcome of audit
The auditor or audit team will finalize a report describing the findings according
to the established WHO standard operating procedure and format. The report
will be communicated by WHO to the laboratory and a copy will be sent to the
national regulatory authority having regulatory oversight over the laboratory.
If any additional information is required, or if corrective action has to be
taken 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 audit will be performed.
8
Training modules can be found on the WHO prequalification website (https://www.who.int/tools/health-
products-regulation-and-prequalification-learning-catalogue).
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WHO Expert Committee on Specifications for Pharmaceutical Preparations Fifty-ninth report
In the event of any disagreement between a laboratory and WHO, a
standard operating procedure for the handling of such disagreements will be
followed to discuss and resolve the issue.
As WHO is responsible for the quality assessment procedure, the
ownership of the reports lies with WHO (without prejudice, however, to any
confidential and 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:
■ 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).
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 audit.
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 United Nations agencies. In such cases, the
concerned QCL shall be informed.
2.7 Results of assessment
Once WHO requirements are met, and the laboratory is considered acceptable in
principle for use by United Nations agencies and their partners, national authorities
of WHO Member States, and procurement agencies serving national authorities
and United Nations agencies (that is, it has been found to meet the WHO-
WHO Technical Report Series, No. 1067, 2026
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”.
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 certification by WHO of the laboratories
(which is the sole prerogative of national authorities).
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.
A copy of this letter will be sent to the national regulatory authority 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.
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Annex 5
In line with World Health Assembly resolution WHA57.14 of 22 May
2004, WHO will – subject to the protection of any confidential and proprietary
information – publish open-access reports on the laboratories considered to
meet WHO-recommended quality standards for QCLs. These reports will be
published on the WHO website.
2.8 Monitoring of WLQCLs
Once the laboratory is included in the list of WLQCLs, it should inform WHO
without delay about the implementation of any subsequent 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 laboratory
information file.
Each WLQCL will be re-evaluated at regular intervals (annually), or earlier
if information indicating the necessity for re-evaluation is obtained by WHO.
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 year and should be submitted by the end of March of the subsequent
year. The following items should be included in the report:
■ a summary of services provided to United Nations agencies and
their partners, national authorities of WHO Member States, and
procurement agencies serving national authorities and United
Nations agencies;
■ the number of samples analysed, differentiating between compliant
and non-compliant samples, including any out-of-specification or
out-of-trend investigations;
■ a list of analytical methods used, including testing parameters and
reference documents;
■ a summary of customer complaints concerning results of analyses
performed by the laboratory;
■ brief details of participation in proficiency testing schemes
(organizing party, methods involved, outcomes and, if appropriate,
corrective measures adopted);
■ listing of inspections and audits performed by external parties,
identifying the party and the scope of the inspection and audit;
■ confirmation of the primary and secondary contact points;
■ in the case that changes have been implemented that have an impact
on the content of the laboratory information file, a summary of
these changes should be included in the report and an updated
laboratory information file should be attached.
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WHO Expert Committee on Specifications for Pharmaceutical Preparations Fifty-ninth report
WHO will conduct re-auditing of WLQCLs in accordance with standard
operating procedures established by WHO. The frequency of such re-audits
depends on WHO’s assessment of the quality risk management factors described
below. Normally, however, such re-audits will take place at least once every three
years. The following factors will be taken into account when planning audits:
■ major changes, for example, to premises, equipment or key personnel;
■ the results of previous inspections or audits by WHO or another
external party, and history of compliance of the laboratory with
WHO-recommended quality standards;
■ the outcomes of participation of the laboratory in proficiency testing
schemes;
■ number and significance of customer complaints:
■ laboratory experience with testing of pharmaceutical products;
■ WHO’s experience with testing services provided by the laboratory.
WHO reserves the right to proceed with the re-auditing of a WLQCL at
any time this is considered necessary based on information or complaints received
by WHO. The national regulatory authority that has regulatory oversight over the
laboratory will be invited to participate in the re-auditing as an observer.
WHO may suspend or withdraw a WLQCL from the list of WHO-listed
quality control laboratories when there is evidence of non-compliance with the
WHO-recommended quality standards for such laboratories or this procedure.
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 United Nations agencies
and their partners, national authorities of WHO Member States, and procurement
agencies serving national authorities and United Nations agencies. In such cases,
WHO Technical Report Series, No. 1067, 2026
WHO will request the QCL to provide evidence that such services had been offered,
or commitments made to continue to offer such services, to the aforementioned
entities. In addition, continued compliance with WHO requirements shall be
verified before the laboratory can resume providing services.
2.9 Monitoring of complaints
Complaints concerning the results of analysis of pharmaceutical products
performed by the WLQCL or concerning the service provided by the WLQCL
that are communicated to WHO will be investigated in accordance with
WHO’s standard operating procedure. The national regulatory authority that
has regulatory oversight over the laboratory will be invited to participate in the
investigation of the complaint.
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Annex 5
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 national regulatory authority
having the regulatory oversight over the laboratory.
2.10 Cost recovery
WHO reserves the right to charge for the quality assessment procedure on a cost
recovery basis.
2.11 Confidentiality undertaking
WHO will require any external auditors (acting as temporary advisers to WHO) to
treat all information to which they gain access during the audits of the laboratory,
or otherwise in connection with the discharge of their responsibilities in regard
to the WLQCL procedure, as confidential and proprietary to WHO or parties
collaborating with WHO in accordance with the terms set out below.
Such auditors will be required to take all reasonable measures to ensure
that confidential information:
■ is not used for any purpose other than the activities described in this
document;
■ is not disclosed or provided to any person who is not bound by
similar obligations of confidentiality and non-use as contained herein.
External auditors 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:
■ was known to them prior to any disclosure by or on behalf of WHO
(including by laboratories); or
■ was in the public domain at the time of disclosure by or on behalf of
WHO (including by laboratories); or
■ has become part of the public domain through no fault of theirs; or
■ has become available to them from a third party not in breach of any
legal obligations of confidentiality.
2.12 Conflict of interest
Before undertaking the work, each external auditor 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 a
real or perceived conflict of interest (or it is felt that there is only an insignificant or
irrelevant conflict of interest), and it is thus deemed appropriate for the auditor in
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WHO Expert Committee on Specifications for Pharmaceutical Preparations Fifty-ninth report
question to undertake this work, they will discharge their functions exclusively as
an adviser to WHO. In this connection, each auditor is required to confirm that the
information disclosed by them in the declaration of interest is correct and complete,
and that they will immediately notify WHO of any change in this information.
All external auditors furthermore agree that, at the laboratory’s request,
WHO will advise the laboratory in advance of the identity of each auditor and the
composition of the team performing the site audit and provide curricula vitae of
the external auditors. The laboratory then has the opportunity to express possible
concerns regarding any of the external auditors to WHO prior to the visit. If
such concerns cannot be resolved in consultation with WHO, the laboratory may
object to an external auditor’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 auditor in question and the
activities to be undertaken by that auditor, in whole or in part.
Fig. A5.1
Flowchart of WHO listing of quality control laboratories
WHO publishes an Quality control laboratory
invitation for Expression submits Expression of interest
of Interest and Laboratory Information File
No Initial screening for
Laboratory Information
File completeness
Yes
WHO Technical Report Series, No. 1067, 2026
Desk assessment if other No File evaluation and Yes
external audit or inspection determination of the need Conduct a site audit
present for a site audit
Outcome of the site audit
Assessment Notify the quality control
No
outcome on laboratory laboratory of negative
acceptability outcome and conclusions
Yes
Listing a WHO-listed quality
control laboratory (WHOLQCL)
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Annex 5
References
1. WHO good practices for pharmaceutical quality control laboratories. In: WHO Expert Committee
on Specifications for Pharmaceutical Preparations: fifty-seventh report (Annex 4). Geneva:
World Health Organization; 2024 (WHO Technical Report Series, No. 1052; https://iris.who.int/
handle/10665/376607).
2. WHO good practices for pharmaceutical microbiology laboratories. In: WHO Expert Committee
on Specifications for Pharmaceutical Preparations: forty-fifth report (Annex 2). Geneva:
World Health Organization; 2011 (WHO Technical Report Series, No. 961; https://iris.who.int/
handle/10665/44079).
3. Quality assurance of pharmaceuticals: a compendium of guidelines and related materials:
volume 1: Good practices and related regulatory guidance, 10th edition. Geneva: World Health
Organization; 2024 (https://iris.who.int/handle/10665/379334).
4. WHO guideline on the implementation of quality management systems for national regulatory
authorities. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations: fifty-
fourth report (Annex 13). Geneva: World Health Organization; 2020 (WHO Technical Report Series,
No. 1025; https://iris.who.int/handle/10665/331814).
5. WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory Systems of
Medical Products, revision VI. Geneva: World Health Organization; 2021 (https://iris.who.int/
handle/10665/341243).
6. Guidelines for preparing a laboratory information file. In: WHO Expert Committee on Specifications
for Pharmaceutical Preparations: thirty-eighth report (Annex 5). Geneva: World Health Organization;
2004 (WHO Technical Report Series, No. 917; https://iris.who.int/handle/10665/42851).
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来源：WHO 药品质量技术报告与指南 · cdn.who.int