21 CFR
Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies
Subpart A - General Provisions
- § 58.1 Scope
- § 58.3 Definitions
- § 58.10 Applicability to studies performed under grants and contracts 2 × 483
- § 58.15 Inspection of a testing facility
Subpart B - Organization and Personnel
- § 58.29 Personnel
- § 58.31 Testing facility management
- § 58.33 Study director 3 × 483
- § 58.35 Quality assurance unit 1 × 483
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
Subpart E - Testing Facilities Operation
Subpart F - Test and Control Articles
- § 58.105 Test and control article characterization 1 × 483
- § 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 3 × 483
- § 58.130 Conduct of a nonclinical laboratory study 2 × 483
Subpart J - Records and Reports
- § 58.185 Reporting of nonclinical laboratory study results 3 × 483
- § 58.190 Storage and retrieval of records and data 1 × 483
- § 58.195 Retention of records 2 × 483
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