TAF-GLP-A01(1)

認證制度實施與發展計畫

OECD優良實驗室操作（GLP） 國家符合性監控系統

（OECD GLP National Compliance Monitoring System） 研究技術資料

委託機關：經濟部標準檢驗局 執行機構：財團法人全國認證基金會 中華民國九十五年十二月

TAF-GLP-A01(1)

經濟合作暨發展組織優良實驗室操作規範與符合性監控

專輯 No.2：優良實驗室操作符合性監控作業指引修訂版 No.3：實驗室查核與研究稽核施行方針修訂版 No.9：製備優良實驗室操作查核報告指引 No.12：要求在他國執行查核及研究稽核

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OECD SERIES

ON

PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE

MONITORING

經濟合作暨發展組織優良實驗室操作規範與符合性監控專輯

Number 2 (Revised)

第 2號 (修訂版)

Guidance for GLP Monitoring Authorities 權責機構監控優良實驗室操作指引

REVISED GUIDES FOR COMPLIANCE MONITORING PROCEDURES FOR GOOD LABORATORY PRACTICE 優良實驗室操作符合性監控作業指引修訂版

ENVIRONMENT MONOGRAPH NO. 110

環境專刊第 110號

Environment Directorate

環境董事會

ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT

Paris 1995

經濟合作發展組織，巴黎 1995

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FOREWORD

前言

The 1981 Council Decision on Mutual Acceptance of Data [C(81)30(Final)], of which the OECD Principles of Good Laboratory Practice[1] are an integral part, includes an instruction for OECD to undertake activities "to facilitate internationally-harmonized approaches to assuring compliance" with the GLP Principles. Consequently, in order to promote the implementation of comparable compliance monitoring procedures, and international acceptance, among Member countries the Council adopted in 1983 the Recommendation concerning the Mutual Recognition of Compliance with Good Laboratory Practice [C(83)95(Final)], which set out basic characteristics of the procedures for monitoring compliance.

在 1981 年理事會在「互相接受數據 [C(81)30(Final)]」的決議中，很重要的「經濟合作發展組織(OECD)優良實驗室操作(GLP)規範」包含了一個 OECD的行動方針，以促進國際間共同保證遵守 GLP規範。隨後，為促使會員國間實施同調而能互相接受的符合性監控做法，理事會在 1983 年正式通過關於「互相承認遵守 GLP」的建議案 [C(83)95(Final)]，此案確立了監控符合做法的基礎。

[1] See The OECD Principles of Good Laboratory Practice, No. 1 in this OECD series on Principles of

GLP and Compliance Monitoring. [1] 見「OECD GLP規範與符合性監控專輯」第 1號，「OECD GLP規範」。

A Working Group on Mutual Recognition of Compliance with GLP was established in 1985, under the chairmanship of Professor V. Silano (Italy), to facilitate the practical implementation of the Council acts on GLP, develop common approaches to the technical and administrative problems related to GLP compliance and its monitoring, and develop arrangements for the mutual recognition of compliance monitoring procedures. The following countries and organisations participated in the Working Group: Australia, Belgium, Canada, Denmark, the Federal Republic of Germany, Finland, France, Italy, Japan, Norway, the Netherlands, Portugal, Spain, Sweden, Switzerland, the United Kingdom, the United States, the Commission of the European Communities, the International Organization for Standardization, the Pharmaceuticals Inspections Convention, and the World Health Organization.

1985 年，在義大利籍 V. Silano 教授主持下，成立了「互相承認遵守 GLP」工作小組，以促使理事會落實 GLP 相關法案，推展有關遵守與監控 GLP 的共用技術和管理問題的方法，並達到互相承認符合性監控做法的共識。此工作小組由下列國家和

國際組織共同參與：澳洲、比利時、加拿大、丹麥、德國、芬蘭、法國、義大利、

日本、挪威、荷蘭、葡萄牙、西班牙、瑞典、瑞士、英國、美國、歐盟委員會、國

際標準化組織、藥檢協會、和世界衛生組織。

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The Working Group developed, inter alia, Guides for Compliance Monitoring Procedures for Good Laboratory Practice, which concern the requisites of administration, personnel and GLP compliance monitoring programmes. These were first published in 1988 in the Final Report of the Working Group.[2] A slightly abridged version was annexed to the 1989 Council Decision-Recommendation on Compliance with Principles of Good Laboratory Practice [C(89)87(Final)], which superseded and replaced the 1983 Council Act.

工作小組特別提出了有關管理、人事與 GLP 符合性監控計畫等要件之「GLP 符合性監控作業指引」。這些資訊首次出版於 1988 年的工作小組總結報告中[2]，經微幅刪訂後附於 1989年理事會關於「遵守 GLP規範」之建議決議案 [C(89)87(Final)]，以取代 1983年的理事會法案。

[2] Final Report of the Working Group on Mutual Recognition of Compliance with Good Laboratory

Practice, OECD Environment Monograph No. 15, March 1988. [2] 互相承認遵守 GLP工作小組總結報告，OECD環境專刊第 15號，1988年 3月。

In adopting that Decision-Recommendation, the Council in Part III.1 instructed the Environment Committee and the Management Committee of the Special Programme on the Control of Chemicals to ensure that the "Guides for Compliance Monitoring Procedures for Good Laboratory Practice" and the "Guidance for the Conduct of Laboratory Inspections and Study Audits" set out in Annexes I and II thereto were updated and expanded, as necessary, in light of developments and experience of Member countries and relevant work in other international organisations.

採納理事會此建議決議案 III.1之內容，責成環境委員會和化學品管制專案計畫之管理委員會，保證在必要時依會員國之發展和經驗及其它國際組織的相關成果，將附

錄 I與 II之「GLP符合性監控作業指引」與「實驗室查核與試驗稽核施行方針」予以更新和補充。

The OECD Panel on Good Laboratory Practice developed proposals for amendments to these Annexes, as well as to Annex III which provides "Guidance for the Exchange of Information concerning National Programmes for Monitoring of Compliance with the Principles of Good Laboratory Practice" and which was amended essentially to include an appendix on "Guidance for Good Laboratory Practice Monitoring Authorities for the Preparation of Annual Overviews of Test Facilites Inspected". These revised Annexes were approved by the Council in a Decision "Amending the Annexes to the Council Decision-Recommendation on Compliance with Principles of Good Laboratory Practice on 9th March, 1995 [C(95)8(Final)].

OECD 之 GLP 小組對上述附錄和附錄 III 提出修訂，附錄 III 提出有關「國家 GLP規範符合性監控計畫之資訊交流指引」，該修訂增加一項附錄「GLP 監控權責機構製備查核試驗單位年報指引」。這些修訂版的附錄由理事會於 1995年 3月 9日對「修訂遵守 GLP規範建議決議案附錄 [C(95)8(Final)]」所批准。

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Part I of this Publication consists of the Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice, as annexed to the 1989 Council Act [C(89)87(Final)] and revised by Council in 1995 [C(95)8(Final)]. The text of that Council Act will be found in Part Two, together with revised Annex III.

本刊第 I 部分包括「GLP 符合性監控作業指引修訂版」，此為 1989 理事會法案 [C(89)87(Final)] 的附錄，並於 1995年經理事會修訂 [C(95)8(Final)]，見本刊與修訂之附錄 III放一起的第二部分。

This document cancels and replaces the Environment Monograph no. 46 entitled "Guides for Compliance Monitoring Procedures for Good Laboratory Practice", published in 1992.

本文取代 1992年出版的環境專刊第 46號標題為「GLP符合性監控作業指引」之內容。

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CONTENTS

目錄

Part One: Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice

第一部分：GLP符合性監控作業指引修訂版

Part Two: Council Decision-Recommendation on Compliance with Principles of Good Laboratory Practice ([C(89)87(Final)]

第二部分：理事會對於「遵守 GLP規範」之建議決議案

Annex III: Revised Guidance for the Exchange of Information concerning National Procedures for Monitoring Compliance

附錄 III： 關於國家符合性監控做法之資訊交流指引修訂版

TAF-GLP-A01(1)

PART ONE:

第一部份

REVISED GUIDES FOR COMPLIANCE MONITORING PROCEDURES FOR

GOOD LABORATORY PRACTICE [3]

GLP符合性監控作業指引修訂版[3]

(As revised by the Council, on 9th March, 1995)

理事會於 1995年 3月 9日修訂

To facilitate the mutual acceptance of test data generated for submission to Regulatory Authorities of OECD Member countries, harmonization of the procedures adopted to monitor good laboratory practice compliance, as well as comparability of their quality and rigour, are essential. The aim of this document is to provide detailed practical guidance to OECD Member countries on the structure, mechanisms and procedures they should adopt when establishing national Good Laboratory Practice compliance monitoring programmes so that these programmes may be internationally acceptable.

為利於互相承認提交給 OECD 會員國主管機關的試驗數據，採取同調的 GLP 符合性監控做法與對等的品質和嚴謹度是有必要的。本文旨在提供詳細的實用指引給

OECD會員國在制定國家的 GLP符合性監控計畫時，所應採取的組織架構、機制與做法，以便為國際間所接受。

[3] The Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice are contained in the revision of Annex I to the Council Decision-Recommendation on Compliance with Principles of Good Laboratory Practice [C(89)87(Final)] and [C(95)8(Final)].

[3] GLP 符合性監控作業指引修訂版被包含在理事會「遵守 GLP 規範」建議決議案之附錄 I 修訂版之中 ([C(89)87(Final)] 和 [C(95)8(Final)])。

It is recognised that Member countries will adopt GLP Principles and establish compliance monitoring procedures according to national legal and administrative practices, and according to priorities they give to, e.g., the scope of initial and subsequent coverage concerning categories of chemicals and types of testing. Since Member countries may establish more than one Good Laboratory Practice Monitoring Authority due to their legal framework for chemicals control, more than one Good Laboratory Practice Compliance Programme may be established. The guidance set forth in the following paragraphs concerns each of these Authorities and Compliance Programmes, as appropriate.

眾所週知，會員國在採用「GLP規範」和制定符合性監控作業時，會取決於國家的

TAF-GLP-A01(1)

法律與行政慣例、及其設定的優先順序，例如有關化學品分類的最初和之後的涵蓋

範圍、與試驗的類型。由於會員國對於化學品管制之法律架構可能有一個以上的

GLP 監控主管機關，因此可能會制定一個以上的 GLP 符合性計畫。以下說明各相關主管機關與符合計畫之指導。

TAF-GLP-A01(1)

DEFINITIONS OF TERMS

專有名詞之定義

The definitions of terms in the "OECD Principles of Good Laboratory Practice" [Annex 2 to Council Decision C(81)30(Final)] are applicable to this document. In addition, the following definitions apply:

在「OECD GLP規範 (理事會決議案 C(81)30(Final) 附錄 2)」中的專有名詞定義亦適用於本文。此外，還應用下列定義：

GLP Principles: Principles of good laboratory practice that are consistent with the OECD Principles of Good Laboratory Practice as set out in Annex 2 of Council Decision C(81)30(Final)[4].

GLP規範：同理事會決議 C(81)30(Final)[4] 附錄 2之「OECD GLP規範」。 [4] See The OECD Principles of Good Laboratory Practice, No.1 in this OECD series on Principles of

GLP and Compliance Monitoring. [4] 見「OECD GLP規範與符合性監控」專輯第 1號，OECD GLP規範。

GLP Compliance Monitoring: The periodic inspection of test facilities and/or auditing of studies for the purpose of verifying adherence to GLP Principles.

GLP 符合性監控：為驗證是否遵守 GLP 規範之目的而為之試驗單位定期查核與/或試驗稽核。

(National) GLP Compliance Programme: The particular scheme established by a Member country to monitor good laboratory practice compliance by test facilities within its territories, by means of inspections and study audits.

(國家) GLP符合計畫：由會員國制定的特定方案，透過查核與試驗稽核以監控其國內的試驗單位是否遵守 GLP。

(National) GLP Monitoring Authority: A body established within a Member country with responsibility for monitoring the good laboratory practice compliance of test facilities within its territories and for discharging other such functions related to good laboratory practice as may be nationally determined. It is understood that more than one such body may be established in a Member country.

(國家) GLP監控權責機構：會員國內成立的某機關組織，負責監控其國內之試驗單位是否符合 GLP，以及其它可能由國家賦予執行類似 GLP 監控功能的職責。而在一個會員國之內可能不只成立一個這樣的機關組織。

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Test Facility Inspection: An on-site examination of the test facility’s procedures and practices to assess the degree of compliance with GLP Principles. During inspections, the management structures and operational procedures of the test facility are examined, key technical personnel are interviewed, and the quality and integrity of data generated by the facility are assessed and reported.

試驗單位查核：對試驗單位之作業與作為的一種現場檢查，以評估其符合 GLP規範的程度。查核時，檢查試驗單位的管理架構與操作程序、訪談主要技術人員、評估

試驗單位所產出之數據的品質與完整性、並做報告。

Study Audit: A comparison of raw data and associated records with the interim or final report in order to determine whether the raw data have been accurately reported, to determine whether testing was carried out in accordance with the study plan and Standard Operating Procedures, to obtain additional information not provided in the report, and to establish whether practices were employed in the development of data that would impair their validity.

試驗稽核：比較原始數據與初稿或完稿報告之相關紀錄，以確定原始數據是否被正確地報告、試驗是否依試驗計畫與標準操作程序執行、是否有報告以外的資料、以

及數據的產出過程是否真實。

Inspector: A person who performs the test facility inspections and study audits on behalf of the (National) GLP Monitoring Authority.

查核員：代表(國家) GLP監控權責機構，執行試驗單位查核與試驗稽核之人員。

GLP Compliance Status: The level of adherence of a test facility to the GLP Principles as assessed by the (National) GLP Monitoring Authority.

GLP符合狀態：由(國家)GLP監控權責機構對某試驗單位遵循GLP規範程度之評價。

Regulatory Authority: A national body with legal responsibility for aspects of the control of chemicals.

主管機關：法律上負責有關化學物品管制的一個國家機構。

TAF-GLP-A01(1)

COMPONENTS OF GOOD LABORATORY PRACTICE

COMPLIANCE MONITORING PROCEDURES

GLP符合性監控作業的內容要件

Administration行政管理

A (National) GLP Compliance Programme should be the responsibility of a properly constituted, legally identifiable body adequately staffed and working within a defined administrative framework.

國家的「GLP符合計畫」應由一個含適當編制職員的法定機構負責推動並在明確的體制內運作。

Member countries should: 會員國應該：

— ensure that the (National) GLP Monitoring Authority is directly responsible for an adequate "team" of inspectors having the necessary technical/scientific expertise or is ultimately responsible for such a "team";

確保此 (國家的) GLP監控權責機構對一個由適量科技專家組成之 "查核員團隊" 負直接或最終之責任。

— publish documents relating to the adoption of GLP Principles within their territories;

出版其國內有關採用「GLP規範」之文件；

— publish documents providing details of the (National) GLP Compliance Programme, including information on the legal or administrative framework within which the programme operates and references to published acts, normative documents (e.g., regulations, codes of practice), inspection manuals, guidance notes, periodicity of inspections and/or criteria for inspection schedules, etc.;

出版 (國家的) GLP符合計畫，提供詳盡文件，包括符合計畫運作之法律或行政架構，以及已頒佈法令的參考文獻、規範文件 (如法規、施行細則)、查核手冊、指引註記、查核週期、與/或查核日程等。

— maintain records of test facilities inspected (and their GLP Compliance Status) and of studies audited for both national and international purposes.

TAF-GLP-A01(1)

為國內及國際之目的，保存試驗單位查核 (及其 GLP 符合狀態) 與試驗稽核之記錄。

Confidentiality保密

(National) GLP Monitoring Authorities will have access to commercially valuable information and, on occasion, may even need to remove commercially sensitive documents from a test facility or refer to them in detail in their reports.

(國家) GLP監控權責構將得以取得具商業價值的資訊，有時，甚至必須從試驗單位取走敏感的商業性文件或在報告中引用細節。

Member countries should: 會員國應該

— make provision for the maintenance of confidentiality, not only by Inspectors but also by any other persons who gain access to confidential information as a result of GLP Compliance Monitoring activities;

制定保密規約。不僅是查核員，凡是因從事「GLP 符合性監控」活動而獲得機密資料的人員皆需遵守。

— ensure that, unless all commercially sensitive and confidential information has been excised, reports of Test Facility Inspections and Study Audits are made available only to Regulatory Authorities and, where appropriate, to the test facilities inspected or concerned with Study Audits and/or to study sponsors.

除非所有商業上的敏感性與機密性資訊已被解除，應確保試驗單位查核與試

驗稽核之報告僅可供主管機關、受檢試驗單位、及/或試驗委託者獲得。

Personnel and Training人員與訓練

(National) GLP Monitoring Authorities should:

(國家) GLP監控權責機構應該：

— ensure that an adequate number of Inspectors is available

確保有足夠的查核人員可用

The number of Inspectors required will depend upon:

需要之查核員人數取決於：

i) the number of test facilities involved in the (National) GLP Compliance Programme;

牽涉到 (國家) GLP符合計畫的試驗單位之數量

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ii) the frequency with which the GLP Compliance Status of the test facilities is to be assessed;

評估試驗單位的 GLP符合狀態之次數

iii) the number and complexity of the studies undertaken by those test facilities

所有試驗單位所執行之試驗項目的數量和複雜程度

iv) the number of special inspections or audits requested by Regulatory Authorities.

主管機關所要求之特別查核或稽核之數量

— ensure that Inspectors are adequately qualified and trained

保證查核員的確稱職且經充分訓練

Inspectors should have qualifications and practical experience in the range of scientific disciplines relevant to the testing of chemicals. (National) GLP Monitoring Authorities should:

查核員應在化學物品試驗相關科學領域方面，具備資格與實務經驗。(國家) GLP監控權責機構應該：

i) ensure that arrangements are made for the appropriate training of GLP Inspectors, having regard to their individual qualifications and experience;

確保依 GLP查核員之資歷與經驗，安排適當訓練；

ii) encourage consultations, including joint training activities where necessary, with the staff of (National) GLP Monitoring Authorities in other Member countries in order to promote international harmonization in the interpretation and application of GLP Principles, and in the monitoring of compliance with such Principles.

鼓勵與其它會員國之 (國家) GLP 監控權責機構成員交流，包括必要時舉辦聯合訓練活動，以促進國際間在解釋與應用 GLP規範，及監控這些規範時的步調一致。

— ensure that inspectorate personnel, including experts under contract, have no financial or other interests in the test facilities inspected, the studies audited or the firms sponsoring such studies

確保查核人員 (包括約聘專家) 與其查核之試驗單位、試驗研究、或試驗委託者之間沒有財務或其他利害關係。

— provide Inspectors with a suitable means of identification (e.g., an identity card).

提供查核員適當的身份證明 (如識別證)

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Inspectors may be: 查核員可能是：

— on the permanent staff of the (National) GLP Monitoring Authority;

(國家) GLP監控權責機構之正式職員；

— on the permanent staff of a body separate from the (National) GLP Monitoring Authority; or

與 (國家) GLP監控權責機構無關之組織機構的正式職員；或者

— employed on contract, or in another way, by the (National) GLP Monitoring Authority to perform Test Facility Inspections or Study Audits.

由 (國家) GLP監控權責機構為執行試驗單位查核或試驗稽核而約聘，或以其它方式僱用之人員。

In the latter two cases, the (National) GLP Monitoring Authority should have ultimate responsibility for determining the GLP Compliance Status of test facilities and the quality/acceptability of a Study Audit, and for taking any action based on the results of Test Facility Inspections or Study Audits which may be necessary.

在後兩者的情況下，(國家) GLP監控權責機構應對評鑑試驗單位的 GLP符合狀態與其試驗稽核之品質/可接受性，以及因試驗單位查核或試驗稽核結果而採取的行動負最後責任。

(National) GLP Compliance Programmes (國家) GLP符合計畫

GLP Compliance Monitoring is intended to ascertain whether test facilities have implemented GLP Principles for the conduct of studies and are capable of assuring that the resulting data are of adequate quality. As indicated above, Member countries should publish the details of their (National) GLP Compliance Programmes. Such information should, inter alia:

GLP 符合性監控之目的在於：確定試驗單位是否在執行試驗時已實施了 GLP 規範與是否能夠確保其得到的數據具有適當的品質。如前所述，會員國應出版他們(國家) 的 GLP符合計畫細節。這些資訊尤其應該：

— define the scope and extent of the Programme

定義符合性監控計畫的範圍和程度

A (National) GLP Compliance Programme may cover only a limited range of chemicals, e.g., industrial chemicals, pesticides, pharmaceuticals, etc., or may include all chemicals. The scope of the monitoring for compliance should be defined, both with respect to the categories of chemicals and to the types of tests subject to it, e.g., physical, chemical, toxicological and/or ecotoxicological.

TAF-GLP-A01(1)

一項 (國家) GLP符合計畫可能僅包含有限範圍的化學品 (如化工產品、農藥及環衛用藥、醫藥等)，亦可能包含所有的化學物品。監控符合性之範圍應明訂關於化學品之類別與試驗項目之類型，如物理的、化學的、毒理的、

及/或生態毒理等。

— provide an indication as to the mechanism whereby test facilities enter the Programme

提供試驗單位有關加入此計畫之機制的指示

The application of GLP Principles to health and environmental safety data generated for regulatory purposes may be mandatory. A mechanism should be available whereby test facilities may have their compliance with GLP Principles monitored by the appropriate (National) GLP Monitoring Authority.

將 GLP 規範應用在為登記註冊目的而做的健康與環境安全數據可以是強制性的。應有一項機制讓適當的 (國家) GLP監控權責機構來監控試驗單位符合 GLP規範的情況。

— provide information on categories of Test Facility Inspections/Study Audits

提供「試驗單位查核/試驗稽核」類別之資訊

A (National) GLP Compliance Programme should include:

一項 (國家) GLP符合計畫應該包括：

i) provision for Test Facility Inspections. These inspections include both a general Test Facility Inspection and a Study Audit of one or more on-going or completed studies;

試驗單位查核之款項。這些查核包括試驗單位的一般查核與一或多項進

行中或已完成之試驗研究的試驗稽核；

ii) provision for special Test Facility Inspections/Study Audits at the request of a Regulatory Authority - e.g., prompted by a query arising from the submission of data to a Regulatory Authority.

應主管機關要求之特定「試驗單位查核/試驗稽核」款項，如來自主管機關依繳交之數據而提出疑問時。

— define the powers of Inspectors for entry into test facilities and their access to data held by test facilities (including specimens, SOP’s, other documentation, etc.)

明訂查核員進入試驗單位及其取得試驗單位持有之數據的權限 (包括檢體、標準操作程序書、其它文件等)。

While Inspectors will not normally wish to enter test facilities against the will of

TAF-GLP-A01(1)

the facility’s management, circumstances may arise where test facility entry and access to data are essential to protect public health or the environment. The powers available to the (National) GLP Monitoring Authority in such cases should be defined.

查核員一般不希望在違背試驗單位管理階層的意願下進入試驗單位，但為了

保護公眾健康或環境而進入試驗單位取得數據的情況是可能出現的。在這種

狀況下，必須明訂 (國家) GLP監控權責機構所具有的權限。

— describe the Test Facility Inspection and Study Audit procedures for verification of GLP compliance

敘述試驗單位查核和試驗稽核作業以驗證 GLP符合性

The documentation should indicate the procedures which will be used to examine both the organisational processes and the conditions under which studies are planned, performed, monitored and recorded. Guidance for such procedures is available in Guidance for the Conduct of Test Facility Inspections and Study Audits (No. 3 in the OECD series on Principles of GLP and Compliance Monitoring).

這類文件應指明用來檢查組織運作與試驗研究之計畫、執行、監控和記錄等

條件的做法。此類作業的指引可見於「試驗單位查核與試驗稽核施行方針」

(OECD專輯第 3號「GLP規範與符合性監控」)。

— describe actions that may be taken as follow-up to Test Facility Inspections and Study Audits.

敘述在完成試驗單位查核和試驗稽核之後可能採取之後續行動。

Follow-up to Test Facility Inspections and Study Audits

試驗單位查核和試驗稽核之後續行動

When a Test Facility Inspection or Study Audit has been completed, the Inspector

TAF-GLP-A01(1)

should prepare a written report of the findings.

在完成試驗單位查核或試驗稽核之後，查核員應準備撰寫一份查核結果報告。

Member countries should take action where deviations from GLP Principles are found during or after a Test Facility Inspection or Study Audit. The appropriate actions should be described in documents from the (National) GLP Monitoring Authority.

在試驗單位查核或試驗稽核期間或之後，當發現有偏離 GLP規範的情形時，會員國應採取措施。而 (國家) GLP監控權責機構應於文件之中說明此因應措施。

If a Test Facility Inspection or Study Audit reveals only minor deviations from GLP Principles, the facility should be required to correct such minor deviations. The Inspector may need, at an appropriate time, to return to the facility to verify that corrections have been introduced.

如果試驗單位查核或試驗稽核只有些微偏離 GLP規範時，試驗單位應被要求改正這些微幅偏離。而查核員可能需要在適當的時機回到試驗單位查驗確已改正。

Where no or where only minor deviations have been found, the (National) GLP Monitoring Authority may:

當發現到無或只有些微偏離時，(國家) GLP監控權責機構可以：

— issue a statement that the test facility has been inspected and found to be operating in compliance with GLP Principles. The date of the inspections and, if appropriate, the categories of test inspected in the test facility at that time should be included. Such statements may be used to provide information to (National) GLP Monitoring Authorities in other Member countries; and/or

發佈一份聲明，說明該試驗單位業經查核且確依 GLP 規範運作，應包括查核日期及當時在試驗單位查核中的試驗類別(若有的話)。此聲明可被用來提供資料給其它會員國之(國家) GLP監控權責機構。並且/或者

— provide the Regulatory Authority which requested a Study Audit with a detailed report of the findings.

提供一份查核結果的詳細報告給要求試驗稽核的主管機關。

Where serious deviations are found, the action taken by (National) GLP Monitoring Authorities will depend upon the particular circumstances of each case and the legal or administrative provisions under which GLP Compliance Monitoring has been established within their countries. Actions which may be taken include, but are not limited to, the following:

當發現嚴重偏離 GLP規範時，(國家) GLP監控權責機構將依個案之特別情況以及該

TAF-GLP-A01(1)

國制定 GLP符合性監控所依據的法律或行政條款來採取行動。所可能採取的行動包括 (但不限於) 如下所列：

— issuance of a statement, giving details of the inadequacies or faults found which might affect the validity of studies conducted in the test facility;

發佈一項聲明，提出所發現之不妥或缺失的細節，這些缺點可能會影響到試

驗單位中所執行之試驗的有效性。

— issuance of a recommendation to a Regulatory Authority that a study be rejected;

發佈一項建議給主管機關，否決某項試驗研究。

— suspension of Test Facility Inspections or Study Audits of a test facility and, for example and where administratively possible, removal of the test facility from the (National) GLP Compliance Programme or from any existing list or register of test facilities subject to GLP Test Facility Inspections;

中止一個試驗單位的實驗室查核或試驗稽核，並且，例如在行政上許可下，

將該試驗單位由 (國家的) GLP 符合計畫或任何接受 GLP 試驗單位查核的現存名冊中除名。

— requiring that a statement detailing the deviations be attached to specific study reports;

要求一份詳述偏離的聲明附在特定的試驗報告中；

— action through the courts, where warranted by circumstances and where legal/ administrative procedures so permit.

在有事實根據以及法律或行政程序許可下，透過法院採取行動。

Appeals Procedures訴願程序

Problems, or differences of opinion, between Inspectors and test facility management will normally be resolved during the course of a Test Facility Inspection or Study Audit. However, it may not always be possible for agreement to be reached. A procedure should exist whereby a test facility may make representations relating to the outcome of a Test Facility Inspection or Study Audit for GLP Compliance Monitoring and/or relating to the action the GLP Monitoring Authority proposes to take thereon.

查核員與試驗單位管理階層之間有問題或意見相左時，通常會在試驗單位查核或試

驗稽核期間得到解決。但是，雙方不可能總是可以達成協議。應有一套辦法，使試

驗單位得以就實驗室查核或試驗稽核的結果，以及/或者有關 GLP 符合性監控權責機構因檢查結果所打算採取之行動做說明。

TAF-GLP-A01(1)

PART TWO:

第二部份

COUNCIL DECISION-RECOMMENDATION

on Compliance with Principles of Good Laboratory Practice

[C(89)87(Final)]

理事會對遵守 GLP規範之建議決議案

(Adopted by the Council at its 717th Session on 2nd October 1989)

(1989年 10月 2日理事會第 717會議正式通過)

The Council, 理事會

Having regard to Articles 5a) and 5b) of the Convention on the Organisation for Economic Cooperation and Development of 14th December 1960;

有關 1960年 12月 14日「OECD全體代表大會」第 5a) 與 5b) 條款；

Having regard to the Recommendation of the Council of 7th July 1977 Establishing Guidelines in Respect of Procedure and Requirements for Anticipating the Effects of Chemicals on Man and in the Environment [C(77)97(Final)];

有關 1977年 7月 7日理事會建議案：「制定有關預估化學品對人體與環境影響之做法與要求的指引 [C(77)97(Final)]」；

Having regard to the Decision of the Council of 12th May 1981 concerning the Mutual Acceptance of Data in the Assessment of Chemicals [C(81)30(Final)] and, in particular, the Recommendation that Member countries, in the testing of chemicals, apply the OECD Principles of Good Laboratory Practice, set forth in Annex 2 of that Decision;

有關理事會在 1981年 5月 12日的決議：關於「互相接受化學品之安全性評估數據 [C(81)30(Final)]」，以及，特別是列於該決議附錄 2，會員國在測試化學物品時，採用「OECD GLP規範」之建議；

Having regard to the Recommendation of the Council of 26th July 1983 concerning the Mutual Recognition of Compliance with Good Laboratory Practice [C(83)95(Final)];

TAF-GLP-A01(1)

有關 1983年 7月 26日之理事會建議案：關於「互相認同遵守 GLP [C(83)95(Final)]」；

Having regard to the conclusions of the Third High Level Meeting of the Chemicals Group (OECD, Paris, 1988);

有關「化學組第三屆高層會議」之結論 (OECD, 巴黎 1988)；

Considering the need to ensure that test data on chemicals provided to regulatory authorities for purposes of assessment and other uses related to the protection of human health and the environment are of high quality, valid and reliable;

考量向主管機關提交登記之化學品的試驗數據，作為評估人體和環境保護用途者，

有確保高品質、有效與可靠之必要性；

Considering the need to minimise duplicative testing of chemicals, and thereby to utilise more effectively scarce test facilities and specialist manpower, and to reduce the number of animals used in testing;

考量有必要減少化學品重複相同的試驗，從而更有效利用有限的試驗單位與專家人

力，同時也減少試驗動物的使用量；

Considering that recognition of procedures for monitoring compliance with good laboratory practice will facilitate mutual acceptance of data and thereby reduce duplicative testing of chemicals;

考量認同監控 GLP符合性之做法，將有助於促進互相接受數據，也因而減少重複的化學品之試驗；

Considering that a basis for recognition of compliance monitoring procedures is an understanding of, and confidence in, the procedures in the Member country where the data are generated;

考量認同符合性監控做法是理解與信賴會員國產出數據過程的基礎；

Considering that harmonized approaches to procedures for monitoring compliance with good laboratory practice would greatly facilitate the development of the necessary confidence in other countries’ procedures;

考量 GLP符合性監控做法的同步化，將大幅促進信任其它國家做法的發展；

On the proposal of the Joint Meeting of the Management Committee of the Special Programme on the Control of Chemicals and the Chemicals Group, endorsed by the

TAF-GLP-A01(1)

Environment Committee;

在化學品管制與化學組特別委員會聯合會議提議下，由環境委員會簽署認可；

PART I

GLP Principles and Compliance Monitoring GLP規範與符合性監控

1. DECIDES that Member countries in which testing of chemicals for purposes of assessment related to the protection of health and the environment is being carried out pursuant to principles of good laboratory practice that are consistent with the OECD Principles of Good Laboratory Practice as set out in Annex 2 of the Council Decision C(81)30(Final) (hereafter called "GLP Principles") shall:

決議：會員國對於作為評估有關人體與環境保護目的而進行之化學品試驗，為尋

求符合理事會決議附錄 2之 OECD GLP規範 [C(81)30(Final)] (此後簡稱「GLP規範」) 所實施的優良實驗室操作，應該：

i) establish national procedures for monitoring compliance with GLP Principles, based on laboratory inspections and study audits;

根據實驗室查核和試驗稽核，制定國家級的 GLP規範符合性監控做法；

ii) designate an authority or authorities to discharge the functions required by the procedures for monitoring compliance; and

指定一或多個權責機構執行符合性監控作業所要求之職責；以及

iii) require that the management of test facilities issue a declaration, where applicable, that a study was carried out in accordance with GLP Principles and pursuant to any other provisions established by national legislation or administrative procedures dealing with good laboratory practice.

要求試驗單位管理階層發佈一項適用的聲明，說明其試驗研究乃符合 GLP 規範實施，並遵守任何其它國家法律或有關 GLP之行政程序規定。

2. RECOMMENDS that, in developing and implementing national procedures for monitoring compliance with GLP Principles, Member countries apply the "Guides for Compliance Monitoring Procedures for Good Laboratory Practice" and the "Guidance for the Conduct of Laboratory Inspections and Study Audits," set out respectively in Annexes I and II which are an integral part of this Decision-Recommendation.[5]

TAF-GLP-A01(1)

建議：在發展並實施國家 GLP規範符合性監控做法時，會員國採用本決議及建議分別列於附錄 I 與 II 部份的「GLP 規範符合性監控作業指引」和「實驗室查核與試驗稽核施行方針」[5]。

[5] The revision of Annex I of the Council Act [set out in C(95)8](Final)] is Part One of this publication. Annex II will be found in No. 3 (Revised) in this OECD series on Principles of GLP and Compliance Monitoring (Environment Monograph No. 111).

[5] 理事會附錄 I的修訂案 [置於 C(95)8](Final)] 是本文的第一部份。附錄 II見 OECD專輯第 3號刊物「GLP規範與符合性監控(修訂版)」(或環境專刊第 111期)。

PART II

Recognition of GLP Compliance among Member countries 會員國間認同 GLP符合性

1. DECIDES that Member countries shall recognise the assurance by another Member country that test data have been generated in accordance with GLP Principles if such other Member country complies with Part I above and Part II paragraph 2 below.

決議：如果某會員國依照上述第 I部份與下列第 II部份第 2段規定的 GLP規範而產出試驗數據，則該會員國所提之保證應被其它會員國承認。

2. DECIDES that, for purposes of the recognition of the assurance in paragraph 1 above, Member countries shall:

決議：為認同上述第 1段所謂之保證，各會員國應該：

i) designate an authority or authorities for international liaison and for discharging other functions relevant to the recognition as set out in this Part and in the Annexes to this Decision-Recommendation;

指派一或多個權責機構，負責國際聯絡與執行其它列於本節與本文建議和決

議部份的附錄之有關認可的職責；

ii) exchange with other Member countries relevant information concerning their procedures for monitoring compliance, in accordance with the guidance set out in Annex III [6] which is an integral part of this Decision-Recommendation; and

依照本建議和決議部份附錄 III [6] 的指引，與其它會員國交流各自有關符合性監控做法之資料，以及

[6] For the revision of Annex III of the Council Act [Revised Guidance for the Exchange of Information concerning National Procedures for Monitoring of Compliance with Principles of

TAF-GLP-A01(1)

Good Laboratory Practice, set out in C(95)8(Final)]. [6] 理事會附錄 III 的修訂案「關於國家 GLP 規範符合性監控做法資訊交流指引修訂版，列於

C(95)8(Final)」。

iii) implement procedures whereby, where good reason exists, information concerning GLP compliance of a test facility (including information focussing on a particular study) within their jurisdiction can be sought by another Member country.

應訂辦法讓在有良好理由的情況下，會員國可以去查察其它會員國轄下之試

驗單位符合 GLP的狀態 (包括某特定試驗研究的資料)。

3. DECIDES that the Council Recommendation concerning the Mutual Recognition of Compliance with Good Laboratory Practice [C(83)95(Final)] shall be repealed.

決議：廢止理事會關於「互相承認遵守 GLP」之建議條文 [C(83)95(Final)]。

PART III

Future OECD Activities OECD的未來作為

1. INSTRUCTS the Environment Committee and the Management Committee of the Special Programme on the Control of Chemicals to ensure that the "Guides for Compliance Monitoring Procedures for Good Laboratory Practice" and the "Guidance for the Conduct of Laboratory Inspections and Study Audits" set out in Annexes I and II [7] are updated and expanded, as necessary, in light of developments and experience of Member countries and relevant work in other international organisations.

委派環境委員會與化學品管制專案管理委員會，確保附錄 I與附錄 II所列之「GLP符合性監控作業指引」和「實驗室查核與試驗稽核施行方針」，必要時可按照各

會員國的發展與經驗及其它國際組織之相關工作，進行更新及推展。 [7] See note 5. (見前述附註 5)

2. INSTRUCTS the Environment Committee and the Management Committee of the Special Programme on the Control of Chemicals to pursue a programme of work designed to facilitate the implementation of this Decision-Recommendation, and to ensure continuing exchange of information and experience on technical and administrative matters related to the application of GLP Principles and the

TAF-GLP-A01(1)

implementation of procedures for monitoring compliance with good laboratory practice.

委派環境委員會與化學品管制專案管理委員會，推行一項就促進實施此建議和

決議而設計的工作計畫，並確保有關 GLP 規範運用與 GLP 之符合性監控作業等，在技術上和行政事務上的資料與經驗能夠持續交流。

3. INSTRUCTS the Environment Committee and the Management Committee of the Special Programme on the Control of Chemicals to review actions taken by Member countries in pursuance of this Decision-Recommendation.

委派環境委員會與化學品管制專案管理委員會審閱會員國在執行這些建議和決

議時所採取的行動。

TAF-GLP-A01(1)

Annex I to C(89)87(Final)/Revised in C(95)8(Final)

C(89)87(Final) 之附錄 I / 修訂於 C(95)8(Final)

REVISED GUIDES FOR COMPLIANCE MONITORING PROCEDURES FOR GOOD LABORATORY PRACTICE

GLP符合性監控作業指引修訂版

(see PART ONE)

(見本文第一部分)

***

Annex II to C(89)87(Final)/Revised in C(95)8(Final)

C(89)87(Final) 之附錄 II / 修訂於 C(95)8(Final)

REVISED GUIDANCE FOR THE CONDUCT OF LABORATORY INSPECTIONS AND STUDY AUDITS

實驗室查核與試驗稽核施行方針修訂版

See OECD series on Principles of GLP and Compliance Monitoring, no. 3 (Revised)

(Environment Monograph No. 111)

見 OECD GLP規範符合性監控專輯，第 3號 (修訂版)

(環境專刊第 111號)

TAF-GLP-A01(1)

Annex III to C(89)87(Final)/Revised in C(95)8(Final)

C(89)87(Final) 之附錄 III / 修訂於 C(95)8(Final)

REVISED GUIDANCE FOR THE EXCHANGE OF INFORMATION CONCERNING NATIONAL PROGRAMMES FOR MONITORING OF

COMPLIANCE WITH PRINCIPLES OF GOOD LABORATORY PRACTICES

關於國家 GLP規範符合性監控計畫資訊交流指引修訂版

(As revised by the Council, on 9th March, 1995)

(1995年 3月 9日理事會修訂)

Part II, paragraph 2 of the Council Act contains a Decision that Member countries exchange information related to their programmes for monitoring of compliance with GLP Principles. This Annex provides guidance concerning the types of information which should be exchanged. While information concerning all of the aspects covered in the "Guides for Compliance Monitoring Programmes procedures for Good Laboratory Practice" (Annex I) are relevant to an understanding of other Member countries’ programmes for GLP Compliance Monitoring, certain types of information are of particular importance. These include:

理事會法案第 II部分第 2段包含一項會員國交流有關「GLP規範符合性監控計畫」資訊之決議。本附錄提供有關應被交流之資訊類型的指引。雖然在「GLP符合性監控作業計畫指引 (附錄 I)」中提到的所有資訊對理解其他會員國的 GLP符合性監控作業很重要，但某些類型的資訊顯得特別重要。包括：

— the GLP Principles adopted nationally;

國家採用的 GLP規範

— the scope of the national programme for monitoring compliance with GLP Principles in terms of the types of chemicals and tests covered;

國家的 GLP規範符合性監控計畫所涵括的化學品類別和試驗類型；

— the identity, legal status, and organisational structure of the (National) GLP Monitoring Authority(ies);

(國家) GLP監控權責機構之身分、法律地位與組織架構；

— the procedures followed during Test Facility Inspections and Study Audits, and the periodicity of inspections and/or criteria for inspection schedules;

TAF-GLP-A01(1)

試驗單位查核和試驗稽核時之程序、查核週期、與/或查核行程的標準；

— the number and qualifications of Inspectors;

查核員之數量與資格；

— the actions available to the (National) GLP Monitoring Authority(ies) in cases of noncompliance, including the ability to inform other Member countries, when necessary, of the results of Test Facility Inspections and Study Audits;

當發生不符合規範案例時，(國家) GLP 監控權責機構可採取之行動，包括必要時可以告知其它會員國有關試驗單位查核和試驗稽核的結果；

— the arrangements for protecting confidentiality of information;

資訊保密之安排；

— the procedures for initiating, conducting and reporting on Test Facility Inspections and Study Audits at the request of other Member countries;

應其它會員國要求時，啟動、實施和報告試驗單位查核和試驗稽核的作業；

— the procedures for obtaining information on test facilities which have been inspected by a (National) GLP Monitoring Authority of another Member country, including such facilities’ compliance status; and

獲得其它會員國 (國家) GLP監控權責機構已查核之試驗單位資訊的程序，包括該試驗單位的符合狀態；以及

— the nature of test facility certifications that studies were carried out following GLP Principles.

試驗單位依照 GLP規範執行試驗研究之證明實物。

Where serious deviations which may have affected specific studies are found, the (National) GLP Monitoring Authority should consider the need to inform relevant (National) GLP Monitoring Authorities in other Member countries of their findings.

當發現可能影響到特定試驗的嚴重偏離時，(國家) GLP監控權責機構應考慮需要通知其它會員國相關之 (國家) GLP監控權責機構。

The names of test facilities subject to Test Facility Inspections within a (National) GLP Compliance Programme, their levels of compliance with the national GLP

TAF-GLP-A01(1)

Principles and the date(s) the Inspections were conducted should be made available annually to (National) GLP Monitoring Authorities in other Member countries upon request (see "Guidance for GLP Monitoring Authorities for the Preparation of Annual Overviews of Test Facilities Inspected" set out in the Appendix to this Annex.)

回應其它會員國 (國家) GLP監控權責機構之請求時，應提供年度「GLP符合計畫」所查核之試驗單位的名稱、符合 GLP規範的程度、與查核日期等資料 (見本附錄之附件「GLP監控權責機構製備試驗單位查核年報指引」)。

Recognition of national programmes for monitoring compliance with GLP Principles may not be immediately forthcoming from other Member countries. Member countries should be prepared to meet genuine concerns in a co-operative way. It may be that a Member country is unable to judge the acceptability of the GLP Compliance Monitoring programmes of another solely on the basis of the exchange of written information. In such cases, Member countries may seek the assurance they require through consultation and discussion with relevant (National) GLP Monitoring Authorities. In this context, OECD provides a forum for the discussion and solving of problems relating to the international harmonization and acceptance of GLP Compliance Monitoring programmes.

監控符合 GLP規範之國家計畫可能無法立即得到其它會員國的認同。會員國應以合作的方式面對真正關切的事件。有可能某一會員國無法單靠交流之書面資訊來判斷

其它 GLP符合性監控做法的可接受性，遇到這種情形，會員國可藉與相關 (國家的) GLP監控權責機構之咨詢和討論以尋求保證。在本文中，OECD提供了一個論壇以討論和解決有關國際間協調和接受 GLP符合性監控計畫之問題。

To facilitate international liaison and the continuing exchange of information, the establishment of a single GLP Monitoring Authority covering all good laboratory practice activities within a Member country has obvious advantages. Where more than one Authority exists, a Member country should ensure that they operate in a consistent way, and have similar GLP Compliance Programmes. The Authority or Authorities with responsibilities for international contacts should be identified by Member countries.

為促進國際聯繫與持續交流資訊，在一個會員國內成立唯一的 GLP監控權責機構以涵蓋所有 GLP的活動有明顯的好處。當有超過一個主管機關存在時，會員國應保證這些主管機關的運作具有一致性，且持有相似的 GLP符合計畫。負責與國際聯絡的主管機關或權責機構應被會員國確認。

Situations will arise where a national Regulatory Authority of a Member country will need to request information on the GLP Compliance Status of a test facility located in another Member country. On rare occasions, and where good reason exists, a particular Study Audit may be requested by a Regulatory Authority of another Member country. Arrangements should be provided whereby these requests may be fulfilled and the results reported back to the requesting Regulatory Authority.

TAF-GLP-A01(1)

一個會員國的國家主管機關要求位於其它會員國的試驗單位之 GLP 符合狀態相關資訊的情形遲早會出現。在罕見與良好理由情況下，其它會員國的主管機關可能會

要求一項特定的試驗稽核。此時應提供安排以滿足其請求，且結果應回報給申請的

主管機關。

Formal international contact should be established for the exchange of information between GLP Monitoring Authorities. However, this should not be understood to prevent informal contacts between Regulatory Authorities and the GLP Monitoring Authority in another Member country, to the extent that such contacts are accepted by the Member countries concerned.

應在 GLP監控權責機構之間建立正式的國際聯絡以交流資訊。但是，這不該被認為是避免主管機關和其它會員國之間的 GLP監控權責機構有非正式的聯絡，在相當程度上這樣的聯絡是被相關會員國所接受的。

National authorities should note that authorities from another Member country may wish to be present at a Test Facility Inspection or Study Audit that they have specifically requested; or they may wish that representative(s) from the Member country seeking a special Test Facility Inspection or Study Audit be present at that Inspection or Audit. In these cases, Member countries should enable Inspectors from another Member country to participate in facility inspections and Study Audits carried out by their GLP Monitoring Authority.

國家的權責機構應注意，其它會員國的權責機構，可能希望能夠出現在它們所特別

要求的試驗單位查核或試驗稽核現場；或者地主國會希望來自尋求特定試驗單位查

核或試驗稽核的會員國代表能夠出現在試驗單位查核或試驗稽核現場。在這些情況

下，會員國應讓其它會員國的查核員能夠參與地主國 GLP監控權責機構所執行之試驗單位查核與試驗稽核。

TAF-GLP-A01(1)

Appendix to Annex III to C(89)87(Final)/Revised in C(95)8(Final)

C(89)87(Final)附錄 III之附件/修訂於 C(95)8(Final)

GUIDANCE FOR GOOD LABORATORY PRACTICE MONITORING AUTHORITIES FOR THE PREPARATION OF ANNUAL OVERVIEWS OF

TEST FACILITIES INSPECTED

GLP監控權責機構製備試驗單位查核年報指引

Overviews of GLP inspections should be circulated to Members of the OECD Panel on GLP and the OECD Secretariat annually before the end of March. The following minimum set of information should allow harmonisation of the overviews exchanged among national GLP monitoring authorities:

GLP 查核年報應於每年三月底前遞交 OECD 之 GLP小組成員及秘書處。各國間協調交流 GLP監控權責機構之綜合報告至少可包括下列資料：

1. Identification of the facility inspected: Sufficient information should be included to make the identification of the facility unequivocal, i.e. the name of the test facility the city and country in which it is located, including inspections abroad.

受檢試驗單位的識別：應含有足夠的資訊以識別受檢單位，換言之，即試驗單

位的名稱、所在城市與國家，包括在國外的查核。

2. Dates of inspections and decisions: month and year of inspection, and, if appropriate, date of final decision on GLP compliance status.

查核與審定日期：查核之年、月，乃至 GLP符合狀態的審定日期。

3. Nature of inspection: A clear indication should be given of whether a full GLP

inspection or only a study audit was carried out, as well as whether the inspection was routine or not and any other authorities which were involved.

查核性質：應指明所執行之查核究竟為全面的 GLP 查核或只是某項試驗稽核，以及此查核是否為例行性、有否其它主管機關參與。

4. Areas of expertise of the facility inspected: Since GLP compliance is related to the tests performed by a facility, the area(s) of expertise of the test facilities inspected should be included in the annual overviews, using the following broad categories:

受檢試驗單位的專業領域：由於 GLP 符合性與試驗單位所執行的試驗有關，年報中受檢的試驗單位之專業領域可依下述大致分類：

TAF-GLP-A01(1)

1) physical-chemical testing 物理化學測試

2) toxicity studies 毒性試驗

3) mutagenicity studies 致變異性試驗

4) environmental toxicity studies on aquatic and terrestrial organisms

水生與陸生生物環境毒理試驗

5) studies on behaviour in water, soil and air; bioaccumulation

在水中、土壤、空氣中之宿命；生物累積性

6) residue studies 殘留量試驗

7) studies on effects on mesocosms and natural ecosystems

對模擬生態實驗室與天然生態之影響試驗

8) analytical and clinical chemistry testing 分析與臨床化學試驗

9) other studies, specify 其它特殊試驗

It is emphasised that these categories are to be used in a flexible manner on a case-by-case basis and that the aim is to provide information related to GLP compliance of test facilities that will be useful for other national monitoring authorities.

要強調的是，這些分類可依個案彈性運用，其目的是為了提供其它國家的監控權責

機構有關試驗單位符合 GLP之資訊。

5. Compliance status: The three following categories should be used to report the

compliance status of facilities:

符合狀態：試驗單位的符合狀態應於報告中分以下三類：

- in compliance 符合

- not in compliance 未符合

- pending (with explanation) 未定 (附說明)

In light of the fact that "pending" is interpreted differently by Member countries and that the varying legal and administrative systems do not allow for harmonised use of the term, explanations must accompany the use of the "pending " status in the national overview of test facilities inspected. Such explanations could include, e.g., "pending reinspection", "pending responses from test facility". "pending completion of administrative procedures". etc.

鑑於"未定"一詞會被會員國做不同的解釋，而多元化的法律和行政體系將無法使此措詞的使用性統一，因此在國家試驗單位查核年報中，使用"未定"狀態時必須附帶

TAF-GLP-A01(1)

說明。這些說明可以包括如 "有待複查中"、"尚待試驗單位回應中"、"等待完成行政程序" 等。

6. Comments: If appropriate, further comments can be made.

評論：如果可行，可進一步下評論。

7. Major deficiencies: At a minimum, individual studies for which a study audit has

revealed serious GLP deficiencies and which have consequently been rejected by receiving authorities should be reported in the annual overviews of test facilities inspected. Since many studies are submitted to authorities in several countries at the same time, however, it is recommended that this kind of information be circulated among national authorities as rapidly as possible on an ad hoc basis, when necessary in addition to the annual overviews.

主要缺失：至少，試驗稽核被查出嚴重缺失以及因而被受理的主管機關駁回之

個別試驗研究應於年報中加以報導。然而，由於許多試驗研究會同時提交到好幾

個國家的主管機關，因此建議，除了年報以外，必要時應以特殊個案處理，用最

快的方式通告這些國家的主管機關。

8. Statements of compliance: When statements of compliance are provided to facilities by national monitoring authorities. they should use the same terminology and categories as the annual overviews

符合性聲明：當符合性聲明由國家的監控權責機構提供給試驗單位時，應使用

與年報相同的術語及分類。

9. Circulation of annual overviews: Overviews should be circulated annually before the end of March to the Members of the GLP Panel and the OECD Secretariat. This information can be released to the public on request.

年報之發行：綜合報告應於每年三月底前遞交給 GLP小組成員與 OECD秘書處。此資訊可應要求予以公開。

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OECD SERIES

ON

PRINCIPLES OF GOOD LABORATORY PRACTICE AND

COMPLIANCE MONITORING

經濟合作暨發展組織優良實驗室操作規範與符合性監控專輯

Number 3 (Revised)

第 3號 (修訂版)

Guidance for GLP Monitoring Authorities 權責機構監控優良實驗室操作指引

REVISED GUIDANCE FOR THE CONDUCT OF LABORATORY INSPECTIONS AND STUDY AUDITS

實驗室查核與研究稽核施行方針修訂版

ENVIRONMENT MONOGRAPH NO. 111

環境專刊第 111號

Environment Directorate

環境董事會

ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT

Paris 1995

經濟合作發展組織，巴黎 1995

TAF-GLP-A01(1)

FOREWORD

前言

The 1981 Council Decision on Mutual Acceptance of Data [C(81)30(Final)], of which the OECD Principles of Good Laboratory Practice[1] are an integral part, includes an instruction for OECD to undertake activities "to facilitate internationally-harmonized approaches to assuring compliance" with the GLP Principles. Consequently, in order to promote the implementation of comparable compliance monitoring procedures, and international acceptance, among Member countries the Council adopted in 1983 the Recommendation concerning the Mutual Recognition of Compliance with Good Laboratory Practice [C(83)95(Final)], which set out basic characteristics of the procedures for monitoring compliance.

在 1981 年理事會的「互相接受數據 [C(81)30(Final)]」決議中，經濟合作發展組織 (OECD) 優良實驗室操作 (GLP) 規範是不可或缺的，包括供 OECD 採取行動之指引 "以促進國際間共同致力於保證符合 GLP 規範"。因此，為了促進在會員國間實施類似的符合性監控做法以及國際間的承認，理事會在 1983年通過有關「互相承認遵守 GLP」的建議案 [C(83)95(Final)]，此案確立了監控符合做法的基礎。

[1] See The OECD Principles of Good Laboratory Practice (No. 1 in this OECD series on Principles of GLP

and Compliance Monitoring).

參見 OECD GLP規範 (優良實驗室操作規範與符合性監控專輯第 1號)。

A Working Group on Mutual Recognition of Compliance with GLP was established in 1985 under the chairmanship of Professor V. Silano (Italy) to facilitate the practical implementation of the Council acts on GLP, develop common approaches to the technical and administrative problems related to GLP compliance and its monitoring, and develop arrangements for the mutual recognition of compliance monitoring procedures. The following countries and organisations participated in the Working Group: Australia, Belgium, Canada, Denmark, the Federal Republic of Germany, Finland, France, Italy, Japan, Norway, the Netherlands, Portugal, Spain, Sweden, Switzerland, the United Kingdom, the United States, the Commission of the European Communities, the International Organization for Standardization, the Pharmaceutical Inspection Convention, and the World Health Organization.

1985 年，在義大利籍 V. Silano 教授主持下，成立了「互相承認遵守 GLP」工作小組，以促使理事會落實 GLP 相關法案，推展有關遵守與監控 GLP 的共用技術和行政問題的方法，以及發展互相承認符合性監控程序的準備工作。有下列國家和組織

參與此工作小組：澳洲、比利時、加拿大、丹麥、德國、芬蘭、法國、義大利、日

本、挪威、荷蘭、葡萄牙、西班牙、瑞典、瑞士、英國、美國、歐洲共同體、國際

標準化組織、國際藥廠查廠協約組織、與世界衛生組織。

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The Working Group developed, inter alia, Guidance for the Conduct of Laboratory Inspections and Study Audits. The Guidance was based on a text developed by the Expert Group on GLP and presented as part of its Final Report in 1982 [2]. The current Guidance was first published in 1988 in the Final Report of the Working Group[3]. A slightly abridged version was annexed to the 1989 Council Decision-Recommendation on Compliance with Principles of Good Laboratory Practice [C(89)87(Final)], which superseded and replaced the 1983 Council Act.

此工作小組特別發展了實驗室查核與試驗稽核的施行方針，乃根據 GLP專家群所發展的內容並為其在 1982年提出之總結報告的一部分[2]。現行版的施行方針首次出版於 1988 年工作小組的總結報告中[3]。一份微幅刪節版則作為附錄附於 1989 年理事會符合 GLP 規範之建議決議案 [C(89)87(Final)] 之後，該案廢止並取代了 1983 年的理事會法案。 [2] Good Laboratory Practice in the Testing of Chemicals, OECD, 1982, out of print.

化學品測試之優良實驗室操作規範，OECD，1982，絕版。 [3] Final Report of the Working Group on Mutual Recognition of Compliance with Good Laboratory

Practice, OECD Environment Monograph No. 15, March 1988.

互相承認遵守 GLP工作小組之總結報告，OECD環境專刊第 15號，1988年 3月。

In adopting that Decision-Recommendation, the Council in Part III.1 instructed the Environment Committee and the Management Committee of the Special Programme on the Control of Chemicals to ensure that the "Guides for Compliance Monitoring Procedures for Good Laboratory Practice" and the "Guidance for the Conduct of Laboratory Inspections and Study Audits" set out in Annexes I and II thereto were updated and expanded, as necessary, in light of developments and experience of Member countries and relevant work in other international organisations.

在通過該建議決議案之後，理事會在 III.1部分中指示環境委員會與化學品管制專案計畫管理委員會確保置於附錄 I與 II之「GLP規範符合性監控作業指引」和「實驗室查核與試驗稽核施行方針」在必要時可以根據會員國的發展和經驗與在其它國際

組織之相關工作成果而予以更新和擴充。

The OECD Panel on Good Laboratory Practice developed proposals for amendments to these Annexes. These revised Annexes were approved by the Council in a Decision "Amending the Annexes to the Council Decision-Recommendation on Compliance with Principles of Good Laboratory Practice" on 9th March, 1995 [C(95)8(Final)].

OECD GLP審查小組就這些附錄提出修訂計畫。這些修訂版附錄由理事員會在 1995年 3月 9日經「理事會符合 GLP規範建議決議附錄修訂案 [C(95)8(Final)]」決議批准。

Part One of this document consists of the Revised Guidance for the Conduct of Laboratory Inspections and Study Audits as annexed to the 1989 Council Act

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[C(89)87(Final)] and revised by Council in 1995 [C(95)8(Final)]. The text of the 1989 Council Act will be found in Part Two.

本文第一部分包括作為1989年理事會法案 [C(89)87(Final)] 附錄之實驗室查核與試驗稽核施行方針修訂版，以及 1995年理事會修訂版 [C(95)8(Final)]。1989年理事會法案置於本文件第二部分。

This document cancels and replaces the Environment Monograph no. 47 entitled "Guides for Compliance Monitoring Procedures for Good Laboratory Practice", published in 1992.

本文撤銷並置換 1992年出版環境專刊第 47號，標題為「GLP符合性監控作業指引」之內容。

TAF-GLP-A01(1)

PART ONE:

第一部份

REVISED GUIDANCE FOR THE CONDUCT OF TEST FACILITY INSPECTIONS AND STUDY AUDITS [4]

試驗單位查核與研究稽核施行方針修訂版[4]

(As revised by the Council, on 9th March, 1995)

理事會於 1995年 3月 9日修訂

INTRODUCTION

緒言

The purpose of this document is to provide guidance for the conduct of Test Facility Inspections and Study Audits which would be mutually acceptable to OECD Member countries. It is principally concerned with Test Facility Inspections, an activity which occupies much of the time of GLP Inspectors. A Test Facility Inspection will usually include a Study Audit or "review" as a part of the inspection, but Study Audits will also have to be conducted from time to time at the request, for example, of a Regulatory Authority. General guidance for the conduct of Study Audits will be found at the end of this document.

本文旨在提供實施試驗單位查核與研究稽核時的指引，以便 OECD會員國可互相接受。此指引主要是有關佔 GLP查核員大部分時間的試驗單位查核。試驗單位查核通常包括某研究稽核或以"審查"作為查核的方式，但研究稽核也必須隨時回應要求而實施，例如，應主管機關之要求。實施研究稽核的指引通則置於本文最後的部分。

Test Facility Inspections are conducted to determine the degree of conformity of test facilities and studies with GLP Principles and to determine the integrity of data to assure that resulting data are of adequate quality for assessment and decision-making by national Regulatory Authorities. They result in reports which describe the degree of adherence of a test facility to the GLP Principles. Test Facility Inspections should be conducted on a regular, routine basis to establish and maintain records of the GLP compliance status of test facilities.

實施試驗單位查核是要確定試驗單位與研究符合 GLP規範的程度，並確定數據的完整性以確保所得之結果在供國家主管機關作評估和決策時具有適當的品質。查核結

果在報告中描述試驗單位遵守 GLP規範的程度。試驗單位查核應定期例行實施，以建立和維持試驗單位之 GLP符合狀況的紀錄。

TAF-GLP-A01(1)

Further clarification of many of the points in this document may be obtained by referring to the OECD Consensus Documents on GLP (on, e.g., the role and responsibilities of the Study Director).

本文中許多要點之進一步說明可參考OECD之GLP共識文件 (如研究主持人之任務與職責)。

[4] The Revised Guidance for the Conduct of Laboratory Inspections and Study Audits is contained in the revision of Annex II to the Council Decision-Recommendation on Compliance with Principles of Good Laboratory Practice [C(89)87(Final) and C(95)8(Final)]. For the text of C(89)87(Final), see page 21 of this publication.

實驗室查核與試驗稽核施行方針修訂版收錄於理事會之符合GLP規範建議決議附錄修訂案之附錄II [C(89)87(Final) and C(95)8(Final)]。C(89)87(Final) 的內容可見於本文後述。

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DEFINITIONS OF TERMS

專有名詞之定義

The definitions of terms in the "OECD Principles of Good Laboratory Practice"[5] [Annex II to Council Decision C(81)30(Final)] and in the "Guides for Compliance Monitoring Procedures for Good Laboratory Practice"[6] [Annex I to Council Decision- Recommendation C(89)87(Final)/revised in C(95)8(Final)] are applicable to this document.

在「OECD GLP規範」[5] [理事會決議案 C(81)30(Final) 附錄 II] 與「GLP符合性監控作業指引」[6] [理事會建議決議案 C(89)87(Final) 附錄 I /修訂於 C(95)8(Final)] 中所定義之專有名詞亦適用於本文。

[5] See The OECD Principles of Good Laboratory Practice (No. 1 in this OECD series on Principles of GLP

and Compliance Monitoring).

見 OECD GLP規範 (優良實驗室操作規範與符合性監控專輯第 1號)。 [6] See Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice (No. 2

(Revised) in this OECD series on Principles of GLP and Compliance Monitoring).

見 GLP符合性監控作業指引修訂版 (優良實驗室操作規範與符合性監控專輯第 2號修訂版)。

TAF-GLP-A01(1)

TEST FACILITY INSPECTIONS

試驗單位查核

Inspections for compliance with GLP Principles may take place in any test facility generating health or environmental safety data for regulatory purposes. Inspectors may be required to audit data relating to the physical, chemical, toxicological or ecotoxicological properties of a substance or preparation. In some cases, Inspectors may need assistance from experts in particular disciplines.

實施符合 GLP 規範之查核可能發生在為管理目的而產出健康或環境安全資料的試驗單位。查核員所可能需要稽核某項物質或配製品有關的物理、化學、毒理學或生

態毒理等特性的資料。在某些情況下，查核員可能需經特定訓練的專家協助。

The wide diversity of facilities (in terms both of physical layout and management structure), together with the variety of types of studies encountered by Inspectors, means that the Inspectors must use their own judgement to assess the degree and extent of compliance with GLP Principles. Nevertheless, Inspectors should strive for a consistent approach in evaluating whether, in the case of a particular test facility or study, an adequate level of compliance with each GLP Principle has been achieved.

查核員所可能遇到五花八門的試驗單位 (從具體配置與管理架構觀點) 以及各式各樣的試驗類型，這意味著查核員必需運用自己的判斷力來評估符合 GLP規範之程度和範圍。不過，查核員在評估某一特定試驗單位或研究是否達到適當 GLP規範的符合程度時，應盡力保持一致性的評估方法。

In the following sections, guidance is provided on the various aspects of the testing facility, including its personnel and procedures, which are likely to be examined by Inspectors. In each section, there is a statement of purpose, as well as an illustrative list of specific items which could be considered during the course of a Test Facility Inspection. These lists are not meant to be comprehensive and should not be taken as such.

以下章節提出之指引，係就試驗單位的各種觀點，包括人員與作業程序等可能被查

核員檢查的部分。在各章節，有一項目的聲明及有關試驗單位被查核時可能被考慮

查核之具體項目清單。這些清單並非意味完全因此不可照單全收。

Inspectors should not concern themselves with the scientific design of the study or the interpretation of the findings of studies with respect to risks for human health or the environment. These aspects are the responsibility of those Regulatory Authorities to which the data are submitted for regulatory purposes.

查核員本身不應介意研究之科學設計或研究觀察事實有關人體健康與環境風險之解

釋。這些觀點是使用數據資料之主管機關作為管理目的之責任。

TAF-GLP-A01(1)

Test Facility Inspections and Study Audits inevitably disturb the normal work in a facility. Inspectors should therefore carry out their work in a carefully planned way and, so far as practicable, respect the wishes of the management of the test facility as to the timing of visits to certain sections of the facility.

試驗單位查核和研究稽核難免會干擾到試驗單位的正常工作。因此，查核員在執行

他們的工作時應謹慎地計畫，盡可能地尊重試驗單位管理階層於設施中確定區域之

查訪時間的期望。

Inspectors will, while conducting Test Facility Inspections and Study Audits, have access to confidential, commercially valuable information. It is essential that they ensure that such information is seen by authorised personnel only. Their responsibilities in this respect will have been established within their (National) GLP Compliance Monitoring Programme.

當查核員進行試驗單位查核和研究稽核時，將得以接觸商業性之機密貴重資訊。很

重要的是，他們必需確保這些資訊僅由被授權者查看。他們在這方面的責任將被規

範在他們(國家的)GLP符合性監控計畫中。

TAF-GLP-A01(1)

INSPECTION PROCEDURES

查核程序

Pre-Inspection 查核前

PURPOSE: To familiarise the Inspector with the facility which is about to be

inspected in respect of management structure, physical layout of buildings and range of studies.

目的：使查核員熟悉被查核單位之管理架構、建築物具體被配置與研究區域。

Prior to conducting a Test Facility Inspection or Study Audit, Inspectors should familiarise themselves with the facility which is to be visited. Any existing information on the facility should be reviewed. This may include previous inspection reports, the layout of the facility, organisation charts, study reports, protocols and curricula vitae (CVs) of personnel. Such documents would provide information on:

進行試驗單位查核或研究稽核之前，查核員本身應先熟悉被查訪之單位。應先審閱

任何有關試驗單位之現存資訊。這可能包括過去的查核報告、試驗單位之配置、組

織圖、研究報告、研究計畫與人員履歷等。這些文件可提供下列之資訊：

— the type, size and layout of the facility;

試驗單位之類別、大小與配置

— the range of studies likely to be encountered during the inspection;

查核時可能會遇到的研究區域；

— the management structure of the facility.

試驗單位的管理架構。

Inspectors should note, in particular, any deficiencies from previous Test Facility Inspections. Where no previous Test Facility Inspections have been conducted, a pre-inspection visit can be made to obtain relevant information.

查核員應特別注意試驗單位前次查核之所有缺失。若未曾實施過試驗單位查核，則

可先作一次查核前拜訪以取得相關資訊。

Test Facilities may be informed of the date and time of Inspector’s arrival, the objective of their visit and the length of time they expect to be on the premises. This could allow the test facility to ensure that the appropriate personnel and documentation

TAF-GLP-A01(1)

are available. In cases where particular documents or records are to be examined, it may be useful to identify these to the test facility in advance of the visit so that they will be immediately available during the Test Facility Inspection.

試驗單位可能被告知查核員之到訪日期與時間、查訪目的、與其預計在場停留時間

。此可使試驗單位確保有適當人員與文件。若有特殊文件或紀錄需要檢查時，可在

查訪前向試驗單位確認這些資料，以便在試驗單位查核期間可立即取得。

Starting Conference 開場會議

PURPOSE: To inform the management and staff of the facility of the reason for the Test Facility Inspection or Study Audit that is about to take place, and to identify the facility areas, study(ies) selected for audit, documents and personnel likely to be involved.

目的：告知試驗單位管理階層與人員即將發生的試驗單位查核或研究稽核的理由，

並確認試驗單位地點、選定要稽核之研究、文件以及可能牽涉到的人員。

The administrative and practical details of a Test Facility Inspection or Study Audit should be discussed with the management of the facility at the start of the visit. At the starting conference, Inspectors should:

試驗單位查核或試驗稽核的行政管理和施行細節應在查訪開始時先與試驗單位管理

階層討論。在開場會議中，查核員應：

— outline the purpose and scope of the visit;

概述查訪之目的與範圍；

— describe the documentation which will be required for the Test Facility Inspection, such as lists of on-going and completed studies, study plans, standard operating procedures, study reports, etc. Access to and, if necessary, arrangements for the copying of relevant documents should be agreed upon at this time;

陳述查核時試驗單位應備的文件，如正進行中和已完成之研究清單、研究計

畫、標準操作程序、研究報告等。若有必要取得和安排複製相關文件，應在

這個時候獲得同意；

— clarify or request information as to the management structure (organisation) and personnel of the facility;

釐清或要求有關試驗單位之管理架構(組織)與人員資訊；

— request information as to the conduct of studies not subject to GLP Principles in the areas of the test facility where GLP studies are being conducted;

要求實施 GLP試驗的試驗單位有關其執行非 GLP研究的資訊；

— make an initial determination as to the parts of the facility to be covered during

TAF-GLP-A01(1)

the Test Facility Inspection;

初次決定在查核期間所要含括的設施部份；

— describe the documents and specimens that will be needed for on-going or completed study(ies) selected for Study Audit;

陳述被選中查核之進行中或已完成之研究的應備文件與檢體樣本；

— indicate that a closing conference will be held at the completion of the inspection.

指示在查核結束後會舉行一個終場會議。

Before proceeding further with a Test Facility Inspection, it is advisable for the Inspector(s) to establish contact with the facility’s Quality Assurance (QA) Unit.

在進一步繼續查核試驗單位之前，查核員最好先與試驗單位的品保部門進行交涉。

As a general rule, when inspecting a facility, Inspectors will find it helpful to be accompanied by a member of the QA unit.

概括來說，查核員在查核試驗單位時，有品保部門人員陪同是有幫助的。

Inspectors may wish to request that a room be set aside for examination of documents and other activities.

查核員可望要求撥出一個房間作為檢查文件與其它活動之用。

Organisation and Personnel 組織與人事

PURPOSE: To determine whether: the test facility has sufficient qualified personnel, staff resources and support services for the variety and number of studies undertaken; the organisational structure is appropriate; and management has established a policy regarding training and staff health surveillance appropriate to the studies undertaken in the facility.

目的：確定試驗單位是否有足夠的合格人員、人力資源、與支援服務來支應其所承

擔的不同種類與數量的研究；組織架構是否適當；以及管理階層是否已建立與其單

位內進行之研究有關的訓練與人員健康把關之適當政策。

The management should be asked to produce certain documents, such as:

管理階層被要求準備某些文件，例如：

— floor plans;

樓面配置圖；

TAF-GLP-A01(1)

— facility management and scientific organisation charts;

設施管理與技術組織系統圖；

— CVs of personnel involved in the type(s) of studies selected for the Study Audit;

與被選中稽核的研究有關之人員的履歷；

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