Details

Autor(en) / Beteiligte

• Organisation for Economic Co-operation and Development

Titel

The Application of the Principles of GLP to in vitro Studies [electronic resource]

Beschreibungen/Notizen

• Bibliographic Level Mode of Issuance: Monograph
• 1. Introduction 9 2. Scope 9 3. Definition of Tterms 10 4. Roles and Responsibilities 11 -4.1 Sponsor 11 -4.2 Test Facility Management 11 -4.3 Archive Contracting Facility 11 -4.4 Test Site Management 11 -4.5 Study Director 12 -4.6 Principal Investigator 12 -4.7 Archivist 12 -4.8 Information Technology (IT) Personnel 12 -4.9 Quality Assurance (QA) Personnel 12 5. Archive Facilities 13 -5.1 Archive Conditions13 -5.2 Disaster Recovery 13 6. Security 14 -6.1 Physical and Operational Security 14 -6.2 Access to the Archive 14 7. Archiving Procedures 15 -7.1 Standard Operating Procedures 15 -7.2 Records and Materials to be retained 15 -7.3 Indexing 17 -7.4 Placement of Records and Materials into the Archives 17 -7.5 Transfers 17 -7.6 Retention Period 18 -7.7 Retrieval 18 -7.8 Disposal of Records and Materials 19 8. Archiving Electronic Records 20 -8.1 Decision to Retain Records Electronically 20 -8.2 Storage Media 20 -8.3 Defined Archive Area on a Computerised System 20 -8.4 Dedicated Electronic Archive System 20 -8.5 Maintenance and Preservation of Electronic Records 21 9. Quality Assurance 22 10. Contract Aarchive Services 22 -10.1 Contracts and/or Service Level Agreements 22 -10.2 Access Arrangements 22 -10.3 Conditions of Storage 22 -10.4 Inspections 22 11. Closure of an Archive 23 -11.1 Principle 23 -11.2 Measures to be Taken 23 -11.3 Inspections by Monitoring Authorities 23 12. References 24
• The purpose of this document is to facilitate the proper application and interpretation of the GLP Principles for the organisation and management of in vitro studies, and to provide guidance for the appropriate application of the GLP Principles to in vitro studies, both for test facilities (management, QA, study director and personnel), and for national GLP compliance monitoring authorities. This Advisory Document intends to provide such additional interpretation of the Principles and guidance for their application to in vitro studies carried out for regulatory purposes. It is organised in such a way as to provide easy reference to the GLP Principles by following the sequence of the different parts of these GLP Principles.
• English