Advisory document for good laboratory practice - Requesting and carrying out inspections and study audits in another country

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

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, 2008
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of ChinaAdministration of Standardization of the People's Republic of China
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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
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