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

Foreword

GB/T 22275 "to implement the requirements of Good Laboratory Practice" is divided into seven sections.

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

--- Part 2. Good Laboratory Practice Research project leader roles and responsibilities;

--- Part 3. Laboratory Supplier of Good Laboratory Practice Principles compliance;

--- Part 4. Good Laboratory Practice principles in the field of applied research;

--- Part 5. Application of the principles of Good Laboratory Practice in short term studies;

--- Part 6. Application of the principles of Good Laboratory Practice in the computerized system;

--- Part 7. application of the principles of good laboratory practice in the organization and management of multi-site studies.

This section GB/T 22275 Part 7.

This section is equivalent to using the Organisation for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) principles and a series of documents for compliance monitoring no. 13. "GLP principles in the organization and management of multi-site study in the application" [ENV/JM/MONO (2002) 9].

This section includes the following editorial changes.

--- Delete information about the OECD, the introduction, preface about the content of the sessions held and directory section.

This part of the National Chemicals Management Standardization Technical Committee dangerous (SAC/TC251) and focal points.

The drafting of this section. Shandong CIQ.

1 Scope

This section GB/T 22275 specifies the multi-site study of management and control, quality assurance, real master schedule, research programs, research Shi, the findings of the report, standard operating procedures, records and materials storage and safekeeping.

Except as expressly exempted national legislation, good laboratory provided for in this part of the normative principles (hereinafter referred to as GLP principles) applicable laws and regulations all non-clinical health and environmental safety studies required, including pharmaceuticals, pesticides, food additives and feed additives, cosmetics, veterinary drugs and similar products registration or application for a permit, as well as industrial chemicals management.

2 Normative references

The following documents contain provisions which, through reference GB/T 22275 in this section constitute provisions of this section. For dated reference documents Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section Parties to research agreement to use the latest versions of these documents. For undated reference documents, the latest versions apply to this section.

GB/T 22275.4 good laboratory practice - Part 4. Good Laboratory Practice principles in the field of applied research GB/T 22278 principles of Good Laboratory Practice

3 Terms and Definitions

GB/T 22278 in the terms and definitions apply to this section.

4 Main technical specifications