title>Advisory document for good laboratory practice - Requesting and carrying out inspections and study audits in another country - GB/T 22276-2008 - Chinese standardNet - bzxz.net
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Advisory document for good laboratory practice - Requesting and carrying out inspections and study audits in another country
Basic Information
Standard ID:
GB/T 22276-2008
Standard Name:Advisory document for good laboratory practice - Requesting and carrying out inspections and study audits in another country
Standard ICS number:Sociology, Services, Organization and Management of Companies (Enterprises), Administration, Transport>>Quality>>03.120.20 Product Certification and Agency Certification, Conformity Assessment
Standard Classification Number:General>>Standardization Management and General Regulations>>A00 Standardization, Quality Management
associated standards
Procurement status:IDT ENV/JM/MONO(2000)3
Publication information
publishing house:China Standards Press
Plan number:20075204-T-469
Publication date:2009-04-01
other information
Release date:2008-08-04
drafter:Song Zhenqian, Liu Xuehui, You Ruihua, Wang Xiaobing, Yu Lixin
Drafting unit:Shandong Entry-Exit Inspection and Quarantine Bureau, etc.
Focal point unit:National Technical Committee on Hazardous Chemicals Management Standardization
This standard is equivalent to the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) principles and compliance monitoring series document No. 12: "Requesting and performing inspections and research audits in another country" [ENV/JM/MONO (2000) 3]. This standard applies to the request and performance of inspections and research audits in another country in accordance with the principles of Good Laboratory Practice (GLP). When inspections and research audits are requested and performed in another country, they should be carried out in accordance with the corresponding procedures. This standard has been edited as follows: - The foreword and introduction of the original text have been deleted. GB/T 22276-2008 Good Laboratory Practice Recommended Document Requesting and Performing Inspections and Research Audits in Another Country GB/T22276-2008 Standard Download Decompression Password: www.bzxz.net
This standard is equivalent to the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) Principles and Conformity Monitoring Series Document No. 12: "Requesting and Performing Inspections and Research Audits in Another Country" [ENV/JM/MONO(2000)3].
This standard applies to requesting and performing inspections and research audits in another country in accordance with the principles of good laboratory practice (GLP). When requesting and performing inspections and research audits in another country, they should be carried out in accordance with the corresponding procedures.
This standard has been edited as follows:
——The foreword and introduction of the original text have been deleted. class="f14" style="padding-top:10px; padding-left:12px; padding-bottom:10px;">
This standard is equivalent to the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) principles and compliance monitoring series document No.12: "Requirements and implementation of inspections and research audits in another country" [ENV/JM/MONO(2000)3].
This standard has been edited as follows:
--- The foreword and introduction of the original text have been deleted.
This standard was proposed and managed by the National Technical Committee for the Administration of Hazardous Chemicals (SAC/TC251).
The drafting units of this standard: Shandong Entry-Exit Inspection and Quarantine Bureau, National Technical Committee for the Administration of Hazardous Chemicals.
The main drafters of this standard: Song Zhenqian, Liu Xuehui, You Ruihua, Wang Xiaobing, Yu Lixin. The clauses in the following documents become the clauses of this standard through reference in this standard. For dated references, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties to agreements based on this standard are encouraged to study whether the latest versions of these documents can be used. For undated references, the latest versions apply to this standard.
GB/T22274.1 Guidelines for Good Laboratory Practice Supervision Departments Part 1: Guidelines for Good Laboratory Practice Compliance Supervision Programs
GB/T22278 Principles of Good Laboratory Practice
Some standard content:
ICS 03. 120. 20 National Standard of the People's Republic of China GB/T 22276—2008 Advisory document for good laboratory practiceRequesting and carrying out inspections and study audits in another countryIssued on August 4, 2008Www.bzxZ.net General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of ChinaAdministration of Standardization of the People's Republic of China Digital image Implementation on April 1, 2009 GB/T 22276—2008 This standard is equivalent to the Organization for Economic Cooperation and Development (OFCD) Good Laboratory Practice (GLP) Principles and Conformity Monitoring Series Document Na.12: Requesting and carrying out inspections and study audits in another country [ENV/JM/MONO(2000)3]. This standard has been edited as follows: 1. The foreword and introduction of the original text have been removed. This standard was proposed and managed by the National Technical Committee for Standardization of Dangerous Chemicals (SAC/TC251). The drafting units of this standard: Shandong Exit-Entry Inspection and Quarantine Bureau, National Technical Committee for Standardization of Dangerous Chemicals. The main drafters of this standard: Song Zhenqian, Liu Xuehui, You Ruihua, Wang Xiaobing, Yu Lixin 1 Scope Good Laboratory Practice Recommended Documents Requirement and Implementation of Inspections and Research Audits in Another Country GB/T 22276—2008 This standard applies to the requirement and implementation of inspections and research audits in another country in accordance with the principles of Good Laboratory Practice (GLP). When inspections and research audits are required and implemented in another country, they should be implemented in accordance with the corresponding procedures. 2 Normative References The clauses in the following documents become the clauses of this standard through reference in this standard. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties to an agreement based on this standard are encouraged to investigate whether the latest versions of these documents can be used. For any undated referenced document, the latest version applies to this standard. GB/T 22274.1 Guidance for Good Laboratory Practice Supervision Departments Part 1: Guidance for Good Laboratory Practice Compliance Supervision Procedures GB/T 22278 Principles of Good Laboratory Practice 3 Terms and Definitions Terms and definitions in G3/T 22278 and G3/T 22274.1 apply to this standard. 4 Recommended procedures for requesting and performing inspections and research audits in another country 4.1 Requests for performing inspections and research audits in another country should be made in writing and with justification. Both countries should make timely arrangements to coordinate this request and provide appropriate materials. 4.2 The GLP supervision departments of both countries should serve as channels for mutual liaison and communication. 4.3 Inspections or research audits should usually be led by the supervision department where the test organization and/or test site is located. One or more inspectors from the applicant country may participate in the inspection or research audit. Departments of the host country may also participate if appropriate. The applicant country shall bear all expenses of its personnel. 4.4 Inspection and research review reports shall be provided to the applicant country (in a language agreed upon by both parties) under the condition that appropriate measures have been taken to protect commercial and industrial secrets as required by national law. 4.5 Any major findings in the inspection or research audit shall be followed up by the appropriate supervisory department. 4.6 The financial arrangements for the inspections and research audits referred to in this standard will be made by the country where the inspection takes place. No payment shall be made to the applicant country for this work. 4.7 The inspections and research audits referred to in this standard shall appear in the annual report of the country responsible for leading the inspections and research audits. 1 GB/T 22276-2008 People's Republic of China National Standard Good Laboratory Practice Recommended Document Requirements and Implementation of Inspections and Research Audits in Another CountryGB/T22276-2008 Published and Distributed by China Standards Publishing House No. 16, Sanlihebei Street, Fuxingmenwai, Beijing Postal Code: 100045 Website: spc.net.cn Tel: 6852 394668517548 China Standard Press, Anhuangdao Printing, Guangdian Printing, distributed by Xinhua Bookstores all over the country Format 880×12301/16 Printing sheet 0.5 Word count 4,000 words First edition in November 2008 First printing in November 2008* Book number: 155066·1-33861 Price 10.00 yuan If there is any printing error, our distribution center will replace it. 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