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GB/T 22274.1-2008Guidance for Good Laboratory Practice (GLP) monitoring authorities -- Part 1: Guides for compliance monitoring procedures for good laboratory practice (English PDF)

良好实验室规范监督部门指南 第1部分:良好实验室规范符合性监督程序指南

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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 22274.1-2008 is the English-translated version of 良好实验室规范监督部门指南 第1部分:良好实验室规范符合性监督程序指南.

GB/T 22274.1-2008 — This section GB/T 22274 specifies the administrative supervision departments of Good Laboratory Practice, confidentiality, personnel and training, GLP Compliance plan, follow-up test facility inspections and study audits, complaints procedures.

This section applies to the territory of China established GLP supervision departments.

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Document preview — GB/T 22274.1-2008

National Standard of the People's Republic of China

ICS
03.120.20
Classification
A 00

Issued by: Standardization Administration of China

Contents

  • What this standard covers1
  • Document data2
  • Standards quoted by this document3

What this standard covers

This standard specifies the good laboratory practice in supervision departments of administration, confidentiality, personnel and training, GLP compliance program audit testing facility inspections and follow-up studies, the appeals process. This section applies to the establishment in our country, GLP supervision departments.

Document data

International classification (ICS): 03.120.20.

Chinese classification (CCS): A00.

Estimated length of the Chinese original: 7,728 words.

Adopted international standard: OCDEGD (95)66, IDT.

Standards quoted by this document

GB/T 22274.2; GB/T 22278

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 5 pages — is available in the English PDF.

Referenced standards

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GB/T 22274.1-2008

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