21 CFR Part 58
PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
- PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter A—General
- Subpart A—General Provisions
- § 58.1 Scope.
- § 58.3 Definitions.
- § 58.10 Applicability to studies performed under grants and contracts.
- § 58.15 Inspection of a testing facility.
- Subpart B—Organization and Personnel
- § 58.29 Personnel.
- § 58.31 Testing facility management.
- § 58.33 Study director.
- § 58.35 Quality assurance unit.
- Subpart C—Facilities
- § 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.
- Subpart D—Equipment
- § 58.61 Equipment design.
- § 58.63 Maintenance and calibration of equipment.
- Subpart E—Testing Facilities Operation
- § 58.81 Standard operating procedures.
- § 58.83 Reagents and solutions.
- § 58.90 Animal care.
- Subpart F—Test and Control Articles
- § 58.105 Test and control article characterization.
- § 58.107 Test and control article handling.
- § 58.113 Mixtures of articles with carriers.
- Subpart G—Protocol for and Conduct of a Nonclinical Laboratory Study
- § 58.120 Protocol.
- § 58.130 Conduct of a nonclinical laboratory study.
- Subparts H-I [Reserved]
- Subpart J—Records and Reports
- § 58.185 Reporting of nonclinical laboratory study results.
- § 58.190 Storage and retrieval of records and data.
- § 58.195 Retention of records.
- Subpart K—Disqualification of Testing Facilities
- § 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.
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