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。
WHO 正式技術報告附錄：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
官方目錄發布日：2026-06-09（原文 9 June 2026）；報告年份、會議日期及適用範圍請以文件正文為準。
官方出版頁：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。
第 1 页
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
Update of Prequalification of quality control laboratories: procedure for assessing
the acceptability, in principle, of quality control laboratories for use by United
Nations agencies, WHO Technical Report Series No. 1003, 2017, Annex 3.
For any further information or request, please send an email to the Norms
and Standards for Pharmaceuticals (NSP) Team at WHO, at email [email protected].
Contents
Abbreviations 170
1. Introduction 170
2. Steps of the procedure 172
2.1 Publication of invitation for expressions of interest 172
2.2 Submission of expressions of interest and laboratory information 173
2.3 Screening of submitted laboratory information 174
2.4 Evaluation of the laboratory information 174
2.5 Site audit 175
2.6 Report and outcome of audit 175
2.7 Results of assessment 176
2.8 Monitoring of WLQCLs 177
2.9 Monitoring of complaints 178
2.10 Cost recovery 179
2.11 Confidentiality undertaking 179
2.12 Conflict of interest 179
References 181
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WHO Expert Committee on Specifications for Pharmaceutical Preparations Fifty-ninth report
Abbreviations
QCL quality control laboratory
WHO World Health Organization
WLA WHO-listed authority
WLQCL WHO-listed quality control laboratory
1. Introduction
This document provides a second revision of the procedure originally published
as Annex 12 in World Health Organization (WHO) Technical Report Series
No. 961, 2011, and revised for the first time in Annex 3 of WHO Technical
Report Series No. 1003, 2017. In this second revision, the procedure formerly
referred to as “prequalification of quality control laboratories” is now designated
“WHO listing of quality control laboratories”, ensuring alignment with WHO’s
broader regulatory terminology and listing mechanisms, such as the WHO-
listed authorities (WLAs). Unlike product-focused prequalification, the listing
model better reflects the role of laboratories as service providers, acknowledges
evaluations already conducted under the WLA framework and reduces
duplication of assessment.
WHO provides United Nations agencies and their partners, national
authorities of WHO Member States, and procurement agencies serving national
authorities and United Nations agencies, 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 WHO good practices for pharmaceutical quality control
WHO Technical Report Series, No. 1067, 2026
laboratories (1) and include, where applicable, good practices for pharmaceutical
microbiology laboratories (2), as well as the relevant parts of good manufacturing
practices (3) and of the WHO guideline on the implementation of quality
management systems for national regulatory authorities (4). This is done through a
standardized assessment procedure. The purpose of the 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.
Participation in the procedure for 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 United Nations agencies and their partners, national authorities of
WHO Member States, and procurement agencies serving national authorities
and United Nations agencies is eligible.
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Accreditation, for example under ISO/IEC 17025, is encouraged. While
accreditation is not a mandatory prerequisite, laboratories are recommended to
work towards obtaining accreditation, as it demonstrates the implementation
of a quality management system and supports their efforts towards the WHO
listing process. Moreover, accreditation involves periodic surveillance and
reassessment, which supports the sustainability of quality management
within the laboratory and drives continuous improvement, both of which are
also required under the WLQCL framework and are therefore beneficial for
maintaining WHO-listed status.
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 (5). More broadly, the regulatory
authority, as the leading institution within the national regulatory system of
medical products, is encouraged to strive towards maturity level 3 across all
regulatory functions.
The assessment procedure established by WHO is based on the following
principles:
■ evidence that the laboratory provides or is committed to offering
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;
■ a comprehensive understanding of the laboratory’s documented
quality management system and testing activities, including the
use of recognized pharmacopoeias (for example, The International
Pharmacopoeia);
■ evaluation of submitted documentation;
■ compliance with WHO-recommended quality standards for
QCLs, that is, good practices for pharmaceutical quality control
laboratories (1), including, where applicable, good practices for
pharmaceutical microbiology laboratories (2), as well as the relevant
parts of good manufacturing practices (3) and of the WHO guideline
on the implementation of quality management systems for national
regulatory authorities (4);
■ monitoring of performance of WLQCLs and their compliance with
WHO requirements.
WHO invites the national regulatory authority having regulatory
oversight over a laboratory participating in the WLQCL procedure to join as an
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observer in the audit 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 European Network of Official Medicines Control Laboratories) of their
submission for designation as a WLQCL.
2. Steps of the procedure
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 2.2 below). In addition to the evaluation of the
information submitted, a site audit (or audits) may be performed.
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 United Nations agencies and their partners, national
authorities of WHO Member States, and procurement agencies serving national
authorities and United Nations agencies identify the need for testing of the quality
of pharmaceutical products.
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 products
are already prequalified by WHO, may be given lower priority or may not be
evaluated at all.
WHO reserves the right to terminate the quality assessment of a laboratory
when (a) the laboratory is not able to provide, or fails to provide, the required
information; (b) when the information supplied is inadequate to complete the
quality assessment effectively; (c) when the laboratory fails or refuses to collaborate
WHO Technical Report Series, No. 1067, 2026
during WHO audits; or (d) when the laboratory is unable to implement corrective
actions that WHO may require within a specified time period.
2.1 Publication of invitation for expressions of interest
WHO will publish an invitation to QCLs to submit an expression of interest to
participate in the WLQCL procedure. Such an invitation will specify the scope
of quality control testing that is subject to WLQCL listing and will be published
widely, that is, 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 expression of interest for WLQCL listing.
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2.2 Submission of expressions of interest
and laboratory information
Each interested laboratory should provide the WHO focal point indicated in the
invitation for expressions of interest with:
■ 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 United
Nations agencies and their partners, national authorities of WHO
Member States, and procurement agencies serving national
authorities and United Nations agencies;
■ the relevant laboratory information.
WHO will record the receipt of the expression of interest 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 (see below) that is not
provided in the quality manual.
The information should be submitted as described in the WHO Guidelines
for preparing a laboratory information file (6) and should cover the areas listed
below, which are based on and complement the content of the guidelines:
■ general information on the laboratory, including the activities
proposed for WLQCL listing and, where applicable, activities related
to the testing of vaccines, biologicals or advanced therapy medicinal
products;
■ accreditation or certification status, if applicable;
■ quality management system implemented, and inspections and
external audits performed in the laboratory;
■ risk management;
■ performance management;
■ crisis management;
■ communication management;
■ participation in proficiency testing schemes or collaborative trials;
■ internal audits;
■ control of data, documentation and records;
■ personnel;
■ premises;
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■ equipment with qualification procedures;
■ reagents, reference substances and reference materials;
■ subcontracting of testing (where applicable);
■ handling of samples;
■ validation and verification of analytical procedures;
■ evaluation and reporting of results;
■ investigation of atypical results (out-of-specification, out-of-trend or
out-of-expectation results);
■ uncertainty of measurement;
■ stability testing (where applicable);
■ microbiological testing (where applicable).
Guidelines for the submission of expressions of interest and for the
preparation and submission of the relevant information are available on the
WHO website and will be sent to interested laboratories upon request.
2.3 Screening of submitted laboratory information
The WHO Guidelines for preparing a laboratory information file (6) will be used
in an initial screening of the information supplied. The information will not be
evaluated if it is not complete. In such cases the laboratory will be requested
to provide additional information within a specified time. If the additional
information is not received by the deadline, the application will be rejected.
2.4 Evaluation of the laboratory information
Laboratory information that complies with the requirements set out in section
2.2 will be evaluated in accordance with a standard operating procedure
WHO Technical Report Series, No. 1067, 2026
established by WHO to ensure uniformity in evaluation of the information. The
information will be evaluated against the WHO-recommended quality standards
for QCLs, namely good practices for pharmaceutical quality control laboratories
(1), including, where applicable, good practices for pharmaceutical microbiology
laboratories (2), as well as the relevant parts of good manufacturing practices
(3) and of the WHO guideline on the implementation of quality management
systems for national regulatory authorities (4). The outcome of the evaluation shall
determine whether the laboratory will be considered for a possible site audit.
A laboratory may submit the report of the inspection performed by a
regulatory authority, or the report of an audit conducted by an accreditation
body or another competent body, together with the laboratory’s response to
any observations. These inspections or audits should have been conducted in
accordance with standards at least equivalent to those outlined above.
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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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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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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 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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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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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