GB/T 22275.1-2008
Requirements of conduct for Good Laboratory Practice (GLP). Part 1: Quality assurance and GLP (English Version)
- Standard No.
- GB/T 22275.1-2008
- Language
- Chinese, Available in English version
- Release Date
- 2008
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Latest
- GB/T 22275.1-2008
- Scope
- This part of GB/T 22275 specifies the specific content and requirements of quality assurance activities under GLP principles, including the responsibilities of quality assurance personnel, the relationship between quality assurance personnel and managers, the qualifications of quality assurance personnel, and participation in standard operating procedures and research plans. Status of development process, quality assurance checks, planning of quality assurance activities and justification of quality assurance activities and methods, reports of quality assurance checks, review of data and final reports, quality assurance statements, quality assurance and non-regulatory studies and small trials Quality Assurance in Institutions. This section applies to quality assurance activities under the GLP principles.
GB/T 22275.1-2008 Referenced Document
- GB/T 22274.1 Guidance for authorities overseeing good laboratory practice - part 1: guidance for procedures for overseeing compliance with good laboratory practice
- GB/T 22278-2008 Principles of Good Laboratory Practice
GB/T 22275.1-2008 history
- 2008 GB/T 22275.1-2008 Requirements of conduct for Good Laboratory Practice (GLP). Part 1: Quality assurance and GLP
GB/T 22275.1-2008 -All Parts
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 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 for the implementation of good laboratory practice part 7: application of good laboratory practice principles to the organization and management of multisite studies