FDA 21 CFR Part 58 Good Laboratory Practice
Good laboratory practice requirements for nonclinical laboratory studies supporting FDA submissions.
Sectors
Articles (36)
§ 58.1 Scope.§ 58.3 Definitions.§ 58.10 Applicability to studies performed under grants and contracts.§ 58.15 Inspection of a testing facility.§ 58.29 Personnel.§ 58.31 Testing facility management.§ 58.33 Study director.§ 58.35 Quality assurance unit.§ 58.41 General.§ 58.43 Animal care facilities.§ 58.45 Animal supply facilities.§ 58.47 Facilities for handling test and control articles.§ 58.49 Laboratory operation areas.§ 58.51 Specimen and data storage facilities.§ 58.61 Equipment design.§ 58.63 Maintenance and calibration of equipment.§ 58.81 Standard operating procedures.§ 58.83 Reagents and solutions.§ 58.90 Animal care.§ 58.105 Test and control article characterization.§ 58.107 Test and control article handling.§ 58.113 Mixtures of articles with carriers.§ 58.120 Protocol.§ 58.130 Conduct of a nonclinical laboratory study.§ 58.185 Reporting of nonclinical laboratory study results.§ 58.190 Storage and retrieval of records and data.§ 58.195 Retention of records.§ 58.200 Purpose.§ 58.202 Grounds for disqualification.§ 58.204 Notice of and opportunity for hearing on proposed disqualification.§ 58.206 Final order on disqualification.§ 58.210 Actions upon disqualification.§ 58.213 Public disclosure of information regarding disqualification.§ 58.215 Alternative or additional actions to disqualification.§ 58.217 Suspension or termination of a testing facility by a sponsor.§ 58.219 Reinstatement of a disqualified testing facility.