WHO 第961号技术报告 附件12 化验室预确认程序 2011（中英文）

毒手药王邓智先

WHO 第961号技术报告 附件12 化验室预确认程序 2011（中英文）
来自Julia

World Health Organization

WHO Technical Report Series, No. 961, 2011

Annex 12 附件12

Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies

联合国机构可使用化验室预确认，可接受性评估程序

Introduction 介绍

1. Steps of the procedure 程序步骤

1.1 Publication of invitation for Expressions of Interest 表示有兴趣的邀请出版物

1.2 Submission of Expressions of Interest and laboratory information 提交化验室信息和兴趣表达

1.3 Screening of submitted laboratory information 提交的化验室信息的筛选

1.4 Evaluation of the laboratory information 化验室信息的评估

1.5 Site inspection 现场检查

1.6 Report and outcome of inspection 检查结果报告

1.7 Results of assessment 评估结果

1.8 Monitoring of prequalified quality control laboratories 通过预确认的化验室的监控

1.9 Monitoring of complaint(s) 投诉监控

1.10 Cost recovery 成本回收

1.11 Confidentiality undertaking 保密责任

1.12 Conflict of interest 利益冲突

References 参考文献


Introduction 介绍

The World Health Organization (WHO) provides United Nations agencies, on request, with advice on the acceptability, in principle, of quality control laboratories that are found to meet WHO recommended quality standards for such laboratories, i.e. Good practices for pharmaceutical quality control laboratories (GPCL) (1) and the relevant parts of good manufacturing practices (GMP) (2). This is done through a standardized quality assessment procedure. The purpose of the quality assessment procedure is to evaluate whether the quality control laboratories to be used for the quality control of pharmaceutical products meet the requirements recommended by WHO for such laboratories.

WHO，在收到要求时，向联合国机构，建议采用其认为符合WHO推荐的质量标准，即，优良药品质量控制化验室规范（GPCL），和优良药品生产规范（GMP）相关部分，原则上可以接受的化验室。这个过程所采用的是一个标准化的质量评估程序，它的目的是评估化验室是否符合WHO对该类化验室推荐的要求。

Participation in the prequalification procedure is voluntary and any pharmaceutical quality control laboratory (governmental or private) could participate. Certification such as ISO (in terms of ISO/IEC17025) is encouraged and will also be considered in the prequalification procedure.

参与预确认程序是自愿的，任何化验室（政府所属的和私人的）均可以申请。我们鼓励化验室获取ISO（按照ISO/IEC17025）证书，在预确认程序中也会加以考虑。

It is recommended that laboratories should work towards obtaining certification.

建议化验室朝着获得认证的方向努力。

The quality assessment procedure established by WHO is based on the following principles:

质量评估程序由WHO基于以下原则建立

— commitment of the laboratory to providing services of testing of pharmaceutical products to United Nations agencies;

— 化验室承诺向联合国机构提供药品测试服务

— a general understanding of the quality assurance management and quality control testing activities of the laboratory;

— 对化验室的质量保证管理和质量控制检测活动具有常规了解

— evaluation of information submitted by the laboratory;

— 对化验室提交的信息进行评估

— assessment of compliance with WHO recommended quality standards for quality control laboratories, i.e. GPCL (1) and the relevant parts of GMP (2); and

— 评估是否符合WHO推荐的质量控制化验室，即GPCL的质量标准，及符合GMP相关部分，以及

— monitoring of performance of prequalified laboratories.

— 对预确认的化验室表现进行监控

WHO invites the national medicines regulatory authority (NMRA) having regulatory oversight over a laboratory participating in the prequalification procedure, to join as an observer in the inspection of the laboratory’s compliance with WHO recommended standards for quality control laboratories. WHO recommends that laboratories expressing an interest in participating in the prequalification procedure, inform the regulatory authority of the country in which they are established as well as relevant networks (e.g. the Official Medicines Control Laboratories (OMCL) network) of their submission for prequalification.

WHO邀请化验室所在国家或地区药品法规当局（NMRA）参与预确认过程，作为观察员陪同审计。WHO推荐化验室表达其参与预确认程序的兴趣，通知所在国家法规当局以及相关的网络（例如OMCL网络）关于其提交预确认的事情。

This procedure is to be followed for prequalification of quality control laboratories for use by the United Nations agencies.

在对联合国机构采用的化验室进行预确认时需要遵守本程序。

1. Steps of the procedure 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 quality control laboratories should submit the information about their activities as requested by WHO (see point 1.2 below).

WHO向有兴趣根据此程序进行评估的化验室索取有关药品质量控制活动信息。化验室应根据WHO的要求（参见以下1.2），提交关于其活动的信息。

In addition to the evaluation of the information submitted, a site inspection (or inspections) may be performed.

除了对所提交的信息进行评估外，可能需要进行现场检查。

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 quality control laboratories in areas where United Nations agencies identify the need for testing of the quality of pharmaceutical products, and to national quality control laboratories and laboratories providing testing services to governments.

如果，由于资源不够或时间限制，WHO不得不设定化验室评估的优先顺序，则优先权会给予处于联合国代理认为需要对药品质量进行检测的地区的质量控制化验室，以及给予国家质量控制化验室，和向政府部门提供检测服务的化验室。

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, the laboratory fails to collaborate in inspections required by WHO and/or is unable to implement corrective actions which WHO may require within a specified time period.

如果化验室不能提供所要求的信息，或所提供的化验室信息不完整，无法有效地完成评估，或化验室无法接受由WHO组织的检查，和/或化验室不能完成WHO要求在一定时间内要求完成的整改措施，WHO保留中止质量评估的权利。

1.1 Publication of invitation for Expressions of Interest 兴趣表达邀请函

WHO will publish an invitation to quality control laboratories to submit an Expression of Interest (EOI) to participate in the prequalification procedure. Such an invitation will specify the scope of quality control testing which is subject to prequalification and will be published widely, i.e. on the WHO web site and possibly also through other media, such as the international press. The invitation will be open and transparent, inviting all interested quality control laboratories to submit the EOI for prequalification.

WHO会发化验室发出邀请，表示有兴趣请这些化验室参与预确认程序。该邀请会指明要进行预确认的检验项目的范围，邀请通知会广泛发布，即，在WHO网站上，也可能通过其它媒体，如国际出版物。邀请是公开透明的，所有有兴趣的化验室均可以提交其EOI申请预确认。

1.2 Submission of Expressions of Interest and laboratory information 表达兴趣和提交化验室信息

Each interested laboratory should provide the WHO focal point indicated in the invitation for EOIs with:

每个感兴趣的化验室应提供WHO在EOI邀请上的关注要点，提供

— a letter expressing interest in participating in the prequalification procedure; and

— 一封信函，表明想要参与预确认程序，和

— the relevant laboratory information.

— 相关的化验室信息

WHO will record the receipt of the EOI from each laboratory in a register.

WHO会登记所有收到的EOI。

Guidelines for the submission of EOIs and for the preparation and submission of the relevant information are available on the WHO web site at apps.who.int/prequal/ and will be sent to interested laboratories upon request.

提交EOI，准备和提交相关信息的指南可以在WHO网站上找到，如有需要，WHO可以发送给化验室。

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.

如果化验室已制作质量手册来记录其质量体系，可以直接与所需要，但未包括在质量手册里的化验室信息（LIF，参见下文）一起提交。

If there is no quality manual, the information should be submitted as described in the document Guidelines for preparing laboratory information file (3) and contain information on the areas listed below:

如果没有质量手册，所提交的信息应按照“化验室信息准备指南”中的要求提交，并包括以下信息

— general information on the laboratory, including activities proposed for prequalification;

— 化验室一般信息，包括预确认的检验项目

— quality management system implemented, and inspections and external audits performed in the laboratory;

— 所采用的质量管理体系，化验室接受的检查和外部审计

— participation in proficiency testing schemes and/or collaborative trials;

— 参与熟练检测项目和/或综合测试的情况

— internal audits;

— 内审

— control of documentation and records;

— 文件和记录控制

— personnel;

— 人员

— premises;

— 设施

— equipment;

— 仪器

— reagents, reference substances and reference materials;

— 试剂、对照物质和对照物料

— subcontracting of testing (where applicable);

— 检测外包（如适用）

— handling of samples;

— 样品处理

— validation of analytical procedures;

— 分析方法验证

— investigation of out-of-specification (OOS) results;

— 不符合结果的调查

— stability testing (where applicable); and

— 稳定性检测（适用时），和

— microbiological testing (where applicable).

— 微生物检测（适用时）

1.3 Screening of submitted laboratory information 提交的化验室信息的筛选

The information submitted by the laboratory will be screened for completeness against the Guidelines for preparing a laboratory information file (3). Incomplete information will not be considered for evaluation. The laboratory will be informed that incomplete information has been received, and be requested to complete it within a specified time period. In the event of noncompliance with this request, the laboratory information will in principle be rejected on grounds of incompleteness and returned to the laboratory.

由化验室提交的信息会根据“化验室信息文件准备指南”进行完整性筛选。不完整的信息不会进入评估。化验室会收到通知，被告知其信息不完整，被要求在指定的时间内补充完整。如果不符合要求，化验室信息在原则上会被因为不完整被拒收，退回化验室。

1.4 Evaluation of the laboratory information 化验室信息的评估

Laboratory information that complies with the requirements set out in section 1.2 above 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 quality control laboratories, i.e. GPCL (1) and the relevant parts of GMP (2), and the laboratory will be considered for a possible site inspection.

WHO会根据SOP对符合上述1.2要求的化验室信息进行评估，以保证信息评估的一致性。信息会根据WHO推荐的化验室质量标准，即GPCL和GMP相关部分，进行评估，对化验室可能会进行现场检查。

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 quality control laboratories, i.e. GPCL (1) and the relevant parts of GMP (2), and the response of the laboratory to the observations made by the authority during inspection or audit.

化验室可能提交检查报告或由法规当局实施的审计报告，该审计标准应至少等同WHO推荐的化验室质量标准，即，GPCL和GMP相关部分，化验室对药监部门检查/审计中发现的缺陷的回复。

Based on WHO’s assessment of the report and response, 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.

基于对报告和回复的评估，如果化验室被认为符合WHO推荐标准下运行，WHO可能会决定不需要进行现场检查。

1.5 Site inspection 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. GPCL (1) and the relevant parts of GMP (2).[1]

根据对化验室信息评估的结果，WHO可能会计划安排一次对化验室的现场检查，以评估该化验室是否符合WHO推荐的质量标准，即GPCL和相关的GMP要求。

34 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 medicines.

检查由在药品检测领域具有相关资质和经验一个检查员，或一个检查组进行。

External inspectors will be appointed in accordance with a SOP established by WHO 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.

WHO可能会根据WHO的SOP聘用外部检查官作为临时顾问。外部检查官必须遵守保密要求，不得与WHO在本程序中相关部分设定的利益原则相冲突。一个WHO成员会协调组成检查团。检查官或检查团会进行检查，根据WHO的SOP将发现的问题上报，保证标准的协调方式。

A representative or representatives of the NMRA having regulatory oversight over a laboratory participating in the prequalification procedure, is invited to accompany the team as an observer.

WHO会邀请化验室所在国家/地区的药监部门派出一位代表作为观察员，陪同审计。

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, United Nations agencies and to the European Directorate for the Quality of Medicines & HealthCare (EDQM).

在协调检查活动时，根据本程序的相关规定，为避免重复检查，无偏见地共享信息，保护化验室知识产权，WHO会将检查相关的信息共享给WHO成员国药监机构、联合国机构和EDQM。

1.6 Report and outcome of inspection 检查结果的报告

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 NMRA having regulatory oversight over the laboratory.

检查官或检查组会形成一份报告，按WHO的SOP的格式，描述根据WHO的SOP所规定的要求发现的缺陷。WHO会与化验室就报告内容进行沟通，发会送一份报告副本给监督该化验室的药监部门。

If any additional information is required, or if a 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 inspection will be performed.

如果需要额外的信息，或如果需要化验室采取整改措施，WHO会推迟决定该化验室是否可以接受，直到对额外的信息进行评估，或整改措施已完成，并认为是满意的。如果根据所收到的信息无法做出决定，可能会需要再进行一次跟踪检查。

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.

如果在有些事情上化验室与WHO持有不同意见，则按照处理该不同意见的WOP进行讨论，并解决该问题。

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:

由于WHO对预确认程序负有责任，报告所有权归属WHO（对报告中化验室的所有保密和知识产权信息没有偏见）。因此，WHO需要被授权使用和出版这些报告，这时，化验室的“保密信息”具有以下含义

— confidential intellectual property, “know-how” and trade secrets (including, e.g. programs, processes or methods, unpublished aspects of trade marks, patents, etc.); and

— 保密的知识产权，“技术诀窍”和贸易机密（包括，例如，计划、工艺或方法，贸易标识未出版方面、专利等），和

— commercial confidences (e.g. structures and development plans).

— 商业机密（例如结构和发展计划）

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.

在开始对信息进行评估和进行现场检查之前，WHO和化验室会通过交换信件来约定保密条款。

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.

根据之前的解释，WHO保留与所有组织内利益相关成员国和联合国机构利益相关机构共享完整报告的权利。

1.7 Results of assessment 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 United Nations agencies (i.e. it has been found to meet the WHO recommended quality standards for quality control laboratories), the laboratory at the specified site will be included in a list referred to as “List of prequalified quality control laboratories”.

如果WHO对质量评估全部完成，结果满意，化验室则被接受（即认为符合WHO推荐的化验室质量标准）可以由联合国机构采用，化验室会被加入索引名单“通过预确认化验室名单”。

Laboratories on the list will be considered to be able to test products in compliance with WHO recommended quality standards for quality control laboratories. Inclusion in the list does not, however, imply any approval by WHO of the laboratories (which is the sole prerogative of national authorities).

在名单上的化验室被认为是可以根据WHO推荐的标准进行药品检测。名字出现在名单上并不表示是由WHO进行了批准（批准是国家机构特有的权利）

Each laboratory will receive a letter from WHO informing it of the outcome of the quality assessment process for that particular laboratory.

每个化验室会收到WHO的一封通知函，告知对该化验室质量评估的结果。

A copy of this letter will be sent to the NMRA of the country where the laboratory is located. The list of prequalified laboratories will be published on the WHO web site and will specify the areas of expertise assessed and considered prequalified. The list will be updated whenever new relevant information is obtained.

这封通知函也会被抄送给该化验室所有国家的NMRA。预确认名单会在WHO网站上公布。名单上，同时会指明专家评估和认为通过预确认的检测项目。一旦有新的相关信息，则清单会进行更新。

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 (WHOPIR(s)) on the laboratories considered to meet WHO recommended quality standards for quality control laboratories. These reports will be published on the WHO web site.

根据2004年5月22日世界卫生条约WHA57.14，WHO会—不违反所有保密和知识信息前提下---出版关于符合WHO推荐的质量标准的化验室的WHO公开检查报告（WHOPIR(s)）。这些报告会公布的WHO网站上。

1.8 Monitoring of prequalified quality control laboratories 预确认化验室的监控

Once the laboratory is included in the list of prequalified quality control laboratories, it should inform WHO without delay about any implemented changes which may have an impact on the prequalification of the laboratory (such as changes to facility, equipment or key personnel) and should submit an updated LIF.

一旦化验室被加入预确认化验室名单，化验室如果有任何会对预确认形成影响的变更（例如对设施、设备或关键人员），应立即通知WHO，并提交更新的LIF。

Each prequalified quality control laboratory will be re-evaluated on a routine basis at regular intervals (annually) or earlier, when information requiring re-evaluation is obtained by WHO.

如果WHO所获得的信息表示需要进行再评估，则每个通过预确认的化验室均需要进行常规再评估，每年或更短。

To enable WHO to carry out re-evaluation, all prequalified laboratories are requested to submit a brief annual report on their activities. The report should cover all activities related to quality control of medicines within the preceding calendar year and should be submitted by the end of March of the subsequent year. The following items should be included in the report:

为使WHO能进行再评估，所有预确认化验室被要求提交一份关于其活动的摘要。该报告应包括该自然年度内所有与药品检测相关的活动，应在第二年的三月底前提交。报告中应报告以下内容

— a summary of services provided to United Nations agencies, other public health organizations procuring medicines and other customers;

— 向联合国机构、其它公共健康组织和其它客户提供的药品检测服务总结

— a summary of number of samples analysed, differentiating between compliant and non-compliant samples;

— 所检测的样品数据总结，将投诉与非投诉样品分开统计

— a list of analytical methods used;

— 所用分析方法清单

— a summary of complaints concerning results of analyses performed by the laboratory received from customers;

— 化验室收到的客户投诉相关结果的总结

— brief details of participation in proficiency testing schemes (organizing party, methods involved, outcomes and, if appropriate, adopted corrective measures);

— 参与熟练检测计划的简要细节（组织方、所涉及方法、结果，和，适当时，所采用的纠正措施）

— listing of inspections and audits performed by external parties, identifying the party and scope of the inspection and audit; and

— 由外部实施的审计和检测清单，检查机构，检查和审计所涉及的范围，和

— 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.

— 如果实施了变更，如果变更对LIF内容产生影响，则这些变更的摘要要包括在报告中，并附上更新过的LIF

WHO will conduct re-inspections of prequalified laboratories in accordance with SOPs established by WHO. 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 be taken into account when planning inspections:

WHO会根据WHO已有的SOP对预确认化验室进行再次检查。这种再次检查的频次取决于WHO对以下所述的质量风险管理因子的评估。一般来说，这种再次检查会至少每三年进行一次。以下因素会在制订检查计划时考虑

— major changes to e.g. premises, equipment, key personnel;

— 对，例如，设施、仪器、关键人员的主要变更

— 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;

— 由WHO或另一个外方机构进行的预审结果，是否符合WHO建议的化验标准的历史

— the outcomes of participation of the laboratory in proficiency testing schemes;

— 化验室参与熟练检测计划的结果

— number and significance of known complaints by customers;

— 已知客户投诉的数量和严重性

— laboratory experience with testing of medicines; and

— 化验室对药物检测的经验，和

— WHO experience with testing services provided by the laboratory.

— 化验室向WHO提供检测服务的经验

WHO reserves the right to proceed with the re-inspection of a prequalified laboratory at any time, when considered necessary based on information or complaints received by WHO. The NMRA which has regulatory oversight over the laboratory will be invited to participate in the re-inspection as an observer.

如果根据所收集的信息或WHO收到的投诉，WHO认为必要时，WHO保留对预确认化验室在任何时候进行再次检查的权利。WHO会邀请负责监管该化验室的NMRA作为观察员陪同检查。

WHO may suspend or withdraw a prequalified quality control laboratory from the List of prequalified quality control laboratories when there is evidence of non-compliance with the WHO recommended quality standards for such laboratories and/or this procedure.

如果有证据证明化验室不符合WHO推荐的质量标准，和/或本程序，WHO可能会暂停或撤销预确认化验室的资格。

1.9 Monitoring of complaint(s) 符合性监控

Complaint(s) concerning the results of analysis of pharmaceutical product(s) performed by the prequalified laboratory or concerning the service provided by the prequalified laboratory, which are communicated to WHO, will be investigated in accordance with an SOP established by WHO. The NMRA which has regulatory oversight over the laboratory will be invited to participate in the investigation of the complaint.

关于预确认化验室检测的药品结果，或关于其提供服务的投诉，会与WHO沟通，由WHO根据其SOP进行调查。化验室所在国的NMRA会被邀请参与投诉的调查。

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 NMRA having the regulatory oversight over the laboratory.

在调查结束后，WHO会提供一份该问题的书面报告，适当时，在其中包括向受调查化验室和NMRA推荐的措施。

1.10 Cost recovery 成本回收

WHO reserves the right to charge for the quality assessment procedure on a cost-recovery basis.

WHO保留索取质量评估所花费用的权利。

1.11 Confidentiality undertaking 保密性

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 prequalification procedure, as confidential and proprietary to WHO or parties collaborating with WHO in accordance with the terms set out below.

WHO会要求所有外部检查官（作为WHO临时顾问）将检查过程中获得的信息，预确认程序中履行职责相关的信息作为保密和知识产权信息对待，根据以下条款对WHO及相关方以外保守机密。

Such inspectors will be required to take all reasonable measures to ensure that confidential information:

这些检查官会被要求采取任何合理的措施以保证这些保密信息

— is not used for any purpose other than the activities described in this document; and

— 不被用于除本文件描述的活动以外的任何目的，以及

— is not disclosed or provided to any person who is not bound by similar obligations of confidentiality and non-use as contained herein.

— 不被公开，不被提供给任何不受类似保密条款约束的人

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:

外部检查官的以下信息不受保密条款责任约束

— was known to them prior to any disclosure by or on behalf of WHO (including by laboratories); or

— 他们在WHO或代表WHO（包括化验室）之前已知的信息，或

— was in the public domain at the time of disclosure by or on behalf of WHO (including by laboratories); or

— 由WHO或代表WHO（包括化验室）获得该信息时，已为公众所知的信息，或

— has become part of the public domain through no fault of theirs; or

— 已因为非外部检查官的原因成为公众所知的一部分信息，或

— has become available to them from a third party not in breach of any legal obligations of confidentiality.

— 外部检查官可以从不负有法定保密责任的第三方获得的信息

1.12 Conflict of interest 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 a real or 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 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.

在接受该工作前，每个外部检查官还（除上述保密要求外）被要求签署一份无利益冲突申明。如果，基于利益冲突申明，没有已存或可预期的利益冲突（或仅有不重要的和/或不相关的利益冲突），因此该检查官适于担任此工作，他/她会排外地承担该WHO的顾问工作。在此情况下，每个检查官均被要求确认其在申明中提供的信息正确完整，他/或会立即通知该类信息的变更。

All external inspectors furthermore agree that, at the laboratory’s request, WHO will advise the laboratory in advance of the identity of each such 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 receipt 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.

所有的外部检查员还要同意，在化验室要求下，WHO会告知化验室各参与现场检查的检查官和检查组成员身份，提供外部检查官简历。化验室有机会在检查开始前向WHO表达其对外部检查官的意见。如果该意见无法通过WHO解决，化验室可以反对该外部检查参加现场检查。化验室必须在收到WHO的检查组成员名单后10天内告知WHO其反对意见。这种情况下，WHO有权取消该检查官的协议，或取消其部分或全部活动。

References 参考文献

1. Good practices for pharmaceutical quality control laboratories. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-fourth report. Geneva, World Health Organization, 2010 (WHO Technical Report Series, No. 957), Annex 1.

药品化验室优良检验规范，WHO第44号报告，技术报告第957号，附件1，2010

2. Quality assurance of pharmaceuticals. A compendium of guidelines and related materials. Vol. 2, Second updated edition. Good manufacturing practices and inspection. Geneva, World Health Organization, 2007; Quality assurance of pharmaceuticals. A compendium of guidelines and related materials. World Health Organization, 2010 (CD-ROM) (apps.who.int/medicinedocs/en/q/).

药品质量保证，指南和相关文献摘要，第二卷，第二更新版本，优良生产和检查规范，2007

3. WHO guidelines for preparing a laboratory information file. Revision. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-eighth report. Geneva, World Health Organization, 2011 (WHO Technical Report Series, No. 961), Annex 13.

WHO化验室信息准备指南，第38号报告，技术报告第961号，附件13，2011

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