GB/T 22272-2008Advisory document for good laboratory practice: Establishment and control of archives that operate in compliance with the principles of GLP (English PDF)
良好实验室规范建议性文件 建立和管理符合良好实验室规范原则的档案
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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 22272-2008 is the English-translated version of 良好实验室规范建议性文件 建立和管理符合良好实验室规范原则的档案.
GB/T 22272-2008 — A non-clinical health and environmental safety studies are archived material and recording production, is in line with the principles of Good Laboratory Practices Important content.
Save the original sample data and research related to specific research produced, it is the only way to reproduce the research process, verifiable final Information in the report, and confirmed that studies with GLP requirements.
The standard test is designed to help institutions to file management in line with the principles of Good Laboratory Practice requirements. This standard does not replace national regulations and/or laws related requirements, such as the period of record-keeping requirements.
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Document preview — GB/T 22272-2008
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 applies to follow the principles of GLP testing facility, signing files, contract quality assurance or information technology services and the commissioning party, as well as GLP compliance monitoring authorities and receiving department. Trial-related organizations should ensure that control their business needs, to assess the applicable regulatory requirements. File components and some aspects of the operation, may be associated with the establishment of public health and safety regulations or laws related to these areas are not within the scope of this standard. Testing agencies and other organizations on the implementation of GLP file records and materials management, from the use of approved standard file management benefit, including those associated metadata.
Document data
International classification (ICS): 03.120.20.
Chinese classification (CCS): A00.
Estimated length of the Chinese original: 12,110 words.
Adopted international standard: OECD GLP, IDT; OECD ENVJMMONO (2007)10, IDT.
Standards quoted by this document
GB/T 22278-2008
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 8 pages — is available in the English PDF.
Referenced standards
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