GB/T 22275.7-2008 Active National standards

GB/T 22275.7-2008 Requirements of conduct for Good Laboratory Practice(GLP)—Part 7:The application of the GLP principles to the organisation and management of multi-site studies

Publish Date: 2008-08-04 Implement Date: 2009-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 22275.7-2008

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Standardized management and general provisions

ICS Name: Product certification, institutional certification, and conformity assessment

Publish Date: 2008-08-04

Implement Date: 2009-04-01

Pages: 8 pages

Scope

This part of GB/T 22275 specifies the management and control of multi-site studies, quality assurance, master schedules, study plans, study implementation, reporting of study results, standard operating procedures, and the storage and custody of records and materials. Except for the explicit exemptions provided by national legislation, the principles of good laboratory practice (hereinafter referred to as GLP principles) specified in this part apply to all non-clinical health and environmental safety studies required by regulations, including the registration or application for licenses of pharmaceuticals, pesticides, food additives and feed additives, cosmetics, veterinary drugs, and similar products, as well as the management of industrial chemicals.

Development Information

Word Count: 13 Thousand words Pages: 8 pages

Same series standard

GB/T 22275.1-2008 Requirements of conduct for Good Laboratory Practice(GLP)—Part 1:Quality assurance and GLP GB/T 22275.2-2008 Requirements of conduct for Good Laboratory Practice(GLP)—Part 2:The role and responsibilities of the study director in GLP studies GB/T 22275.3-2008 Requirements of conduct for Good Laboratory Practice(GLP)—Part 3:Compliance of laboratory suppliers with GLP principles GB/T 22275.4-2008 Requirements of conduct for Good Laboratory Practice(GLP)—Part 4:The application of the GLP principles to field studies GB/T 22275.5-2008 Requirements of conduct for Good Laboratory Practice(GLP)—Part 5:The application of the GLP principles to short term studies GB/T 22275.6-2008 Requirements of conduct for Good Laboratory Practice(GLP)—Part 6:The application of the principles of GLP to computerised systems

Referenced Standards

GB/T 22275.4-2008 Requirements of conduct for Good Laboratory Practice(GLP)—Part 4:The application of the GLP principles to field studies GB/T 22278-2008 Principles of Good Laboratory Practice

Adopt standards

经济合作与发展组织(OECD)良好实验室规范(GLP)原则和符合性监督系列文件No.13:《GLP原则在多场所研究的组织和管理中的应用》[ENV/JM/MONO(2002)9]

Related Standards

GB/T 12707-1991 Abolished

GB/T 12707-1991 Directives for the grading of industrial product quality

Publish Date: 1991-01-05

GB/T 14237-1993 Abolished

GB/T 14237-1993 Manufacturer's declaration of export product conformity with standards

Publish Date: 1993-03-17

GB/T 14436-1993 Abolished

GB/T 14436-1993 General principles of industrial product guarantee documents

Publish Date: 1993-06-10

GB/T 15486-1995 Abolished

GB/T 15486-1995 Calibration and testing laboratory accreditation systems—General requirements for operation and recognition

Publish Date: 1995-02-14

GB/T 15483.1-1999 Replaced

GB/T 15483.1-1999 Proficiency testing by interlaboratory comparisons—Part 1:Development and operation of proficiency testing schemes

Publish Date: 1999-03-08

GB/T 15483.2-1999 Replaced

GB/T 15483.2-1999 Proficiency testing by interlaboratory comparisons—Part 2:Selection and use of proficiency testing schemes by laboratory accreditation bodies

Publish Date: 1999-03-08