PART AREVISED GUIDES FOR COMPLIANCE MONITORING PROCEDURES FOR GOOD LABORATORY PRACTICEDefinitions 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 AUDITSIntroduction 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(88/320/EEC) (repealed)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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Annotations:
Amendments (Textual)
Repealed by Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (Codified version) (Text with EEA relevance).