GB/T 22272-2008 Advisory document for Good Laboratory Practice: Establishment and control of archives that operate in compliance with principles of GLP (English Version)
General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
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GB/T 22272-2008
Scope
This standard is applicable to testing institutions, contracting archives, contracting quality assurance or information technology (IT) service institutions and entrusting parties that follow GLP principles, as well as GLP compliance supervision departments and receiving departments. Organizations involved in trials should ensure that applicable regulatory requirements are assessed against their business needs. Certain aspects of the construction and operation of records that may be relevant to establishing regulations or laws for public health and safety are outside the scope of this standard. Testing bodies and other organizations implementing GLP records and materials for records and materials can benefit from using recognized standards for records management, including those related metadata.
2008GB/T 22272-2008 Advisory document for Good Laboratory Practice: Establishment and control of archives that operate in compliance with principles of GLP