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

Foreword

GB/T 22275 "good laboratory practice requirements" is divided into seven parts.

--- Part 1. Quality Assurance and Good Laboratory Practice;

--- Part 2. Tasks and responsibilities of project leaders in good laboratory norms;

--- Part 3. laboratory suppliers on the principles of Good Laboratory Compliance;

--- Part 4. Principles of good laboratory norms in the field of research applications;

--- Part 5. good laboratory norms in the application of short-term research;

--- Part 6. The application of good laboratory norms in computerized systems;

--- Part 7. Good Laboratory Practice Principles in the organization and management of multi-site research applications.

This section GB/T 22275 Part 4.

This section identical with the Organization for Economic Co-operation and Development (OECD) Good Laboratory Practice (GLP) principles and compliance monitoring series of documents no. 6. "The Application of GLP Principles in Field Research" [ENV/JM/MONO (99) 22].

This section made the following editorial changes.

--- Remove the foreword and directory section.

This part of the National Standardization Technical Committee for the management of hazardous chemicals (SAC/TC251) proposed and managed.

This part of the drafting unit. Exit Inspection and Quarantine of Shandong.

1 Scope

GB/T 22275 provisions of this part of the field research organizations and personnel testing organizations, quality assurance programs, test facilities, equipment, Materials, reagents, test systems, test samples and references, standard operating procedures, reports of findings, records and storage and retention of materials.

In addition to the explicit exemptions from national legislation, the Good Laboratory Practice Principles (hereinafter referred to as GLP Principles) as set forth in this section apply to laws and regulations all required non-clinical health and environmental safety studies, including medicines, pesticides, food additives and feed additives, cosmetics, veterinary drugs and Registration of similar products or application for permits, and management of industrial chemicals.

2 Normative references

The following documents contain provisions that, through the reference in this part of GB/T 22275, become the provisions of this section. Any reference to the date of the citation all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to be reached under this section the parties to the agreement examine whether the latest versions of these documents are available. For undated references, the latest version applies to this book section.

GB/T 22275.1 Good Laboratory Practice requirements Part 1. Quality Assurance and Good Laboratory Practice GB/T 22278-2008 Principles of Good Laboratory Practice

3 Terms and definitions

GB/T 22278-2008 Terms and definitions apply to this section.

4 Main technical specifications