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ANNEX
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PART AREVISED GUIDES FOR COMPLIANCE MONITORING PROCEDURES FOR GOOD LABORATORY PRACTICE
Definitions of terms
Components of good laboratory practice compliance monitoring procedures
Administration
Confidentiality
Personnel and training
(National) GLP compliance programmes
Follow-up to test facility inspections and study audits
Appeals procedures
PART BREVISED GUIDANCE FOR THE CONDUCT OF TEST FACILITY INSPECTIONS AND STUDY AUDITS
Introduction
Definitions of terms
Test facility inspections
Inspection procedures
Pre-inspection
Starting conference
Organisation and personnel
Quality assurance programme
Facilities
Care, housing and containment of biological test systems
Apparatus, materials, reagents and specimens
Test systems
Physical and chemical systems
Biological test systems
Test and reference substances
Standard operating procedures
Performance of the study
Reporting of study results
Storage and retention of records
Study audits
Completion of inspection or study audit

Council Directive

of 7 June 1988

on the inspection and verification of Good Laboratory Practice (GLP)

(88/320/EEC) (repealed)

F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .