GB/T 22275.1-2008 Active National standards

GB/T 22275.1-2008 Requirements of conduct for Good Laboratory Practice(GLP)—Part 1:Quality assurance and GLP

GB/T 22275.1-2008 Requirements of conduct for Good Laboratory Practice(GLP)—Part 1:Quality assurance and GLP

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 22275.1-2008

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: 7 pages

Scope

This part of GB/T 22275 specifies the specific content and requirements of quality assurance activities under the GLP principles, including the responsibilities of quality assurance personnel, the communication between quality assurance personnel and managers, the qualifications of quality assurance personnel and their participation in the process of formulating standard operating procedures and research plans, quality assurance inspections, planning of quality assurance activities and justification of quality assurance activities and methods, reporting of quality assurance inspections, review of data and final reports, quality assurance statements, and quality assurance in non-regulatory research and small-scale experimental institutions. This part is applicable to quality assurance activities under the GLP principles.

Development Information

Word Count: 10 Thousand words Pages: 7 pages

Same series standard

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 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

Referenced Standards

GB/T 22278-2008 Principles of Good Laboratory Practice GB/T 22274.1-2008 Guidance for Good Laboratory Practice(GLP)monitoring authorities—Part 1:Guides for compliance monitoring procedures for GLP

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.4:《质量保证与GLP》[ENV/JM/MONO(99)20]

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