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