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GB/T 22278-2008Principles of good laboratory practice (English PDF)

良好实验室规范原则

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Issued by

Standardization Administration of China

Level / Type

National · Recommended

Issue date

August 4, 2008

Implementation date

April 1, 2009

Scope

GB/T 22278-2008 is the English-translated version of 良好实验室规范原则.

GB/T 22278-2008 — This standard specifies the Good Laboratory Practice (GoodLaboratoryPractice, hereinafter referred to as GLP) related terms and definitions to and main technical specifications, including test organizations and personnel agencies, quality assurance programs, facilities, equipment, materials and reagents, test systems, test Report samples and reference standard operating procedures, the implementation of research findings, and the recording material storage and safekeeping.

Non-clinical health and environmental safety studies covered by the principles of GLP specified in this standard, including the laboratory, greenhouse and field trials of jobs.

Except as expressly exempted national legislation, the provisions of this standard GLP principles apply to all non-clinical health and the requirements in the regulations Environmental safety studies, including registration or apply for a license in medicine, pesticides, food additives and feed additives, cosmetics, veterinary drugs and similar products, and industrial chemicals management.

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Document preview — GB/T 22278-2008

National Standard of the People's Republic of China

ICS: 03.120.20
Classification: A 00

Issued by: Standardization Administration of China

What this standard covers1
Document data2

What this standard covers

This standard specifies the Good Laboratory Practices related terms and definitions, as well as the main technical specifications, including testing the organization and personnel, quality assurance programs, facilities, equipment, materials and reagents, test systems, test samples and reference, standard operating program, the implementation of the study, the findings of the reports, records and materials storage and safekeeping. This standard covers the principles stipulated in the non-clinical GLP health and environmental safety studies, including in the laboratory, greenhouse and field work carried out. In addition to national legislation explicitly exempted under this standard GLP principles apply to regulations required all non- clinical health and environmental safety studies, including pharmaceuticals, pesticides, food additives and feed additives, cosmetics, veterinary drugs and similar products registered or applied permits, and industrial chemicals management.

Document data

International classification (ICS): 03.120.20.

Chinese classification (CCS): A00.

Estimated length of the Chinese original: 1,316 words.

Adopted international standard: OECD GLP, IDT; ENVMCCHEM (98)17, IDT.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 1 pages — is available in the English PDF.

Referenced standards

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