Title 40

PART 792

Part 792 - Good Laboratory Practice Standards

PART 792 - GOOD LABORATORY PRACTICE STANDARDS Authority:15 U.S.C. 2603. Source:54 FR 34043, Aug. 17, 1989, unless otherwise noted.

40:35.0.1.1.3.1SUBPART A
Subpart A - General Provisions
40:35.0.1.1.3.1.1.1SECTION 792.1
   792.1 Scope.
40:35.0.1.1.3.1.1.2SECTION 792.3
   792.3 Definitions.
40:35.0.1.1.3.1.1.3SECTION 792.10
   792.10 Applicability to studies performed under grants and contracts.
40:35.0.1.1.3.1.1.4SECTION 792.12
   792.12 Statement of compliance or non-compliance.
40:35.0.1.1.3.1.1.5SECTION 792.15
   792.15 Inspection of a testing facility.
40:35.0.1.1.3.1.1.6SECTION 792.17
   792.17 Effects of non-compliance.
40:35.0.1.1.3.2SUBPART B
Subpart B - Organization and Personnel
40:35.0.1.1.3.2.1.1SECTION 792.29
   792.29 Personnel.
40:35.0.1.1.3.2.1.2SECTION 792.31
   792.31 Testing facility management.
40:35.0.1.1.3.2.1.3SECTION 792.33
   792.33 Study director.
40:35.0.1.1.3.2.1.4SECTION 792.35
   792.35 Quality assurance unit.
40:35.0.1.1.3.3SUBPART C
Subpart C - Facilities
40:35.0.1.1.3.3.1.1SECTION 792.41
   792.41 General.
40:35.0.1.1.3.3.1.2SECTION 792.43
   792.43 Test system care facilities.
40:35.0.1.1.3.3.1.3SECTION 792.45
   792.45 Test system supply facilities.
40:35.0.1.1.3.3.1.4SECTION 792.47
   792.47 Facilities for handling test, control, and reference substances.
40:35.0.1.1.3.3.1.5SECTION 792.49
   792.49 Laboratory operation areas.
40:35.0.1.1.3.3.1.6SECTION 792.51
   792.51 Specimen and data storage facilities.
40:35.0.1.1.3.4SUBPART D
Subpart D - Equipment
40:35.0.1.1.3.4.1.1SECTION 792.61
   792.61 Equipment design.
40:35.0.1.1.3.4.1.2SECTION 792.63
   792.63 Maintenance and calibration of equipment.
40:35.0.1.1.3.5SUBPART E
Subpart E - Testing Facilities Operation
40:35.0.1.1.3.5.1.1SECTION 792.81
   792.81 Standard operating procedures.
40:35.0.1.1.3.5.1.2SECTION 792.83
   792.83 Reagents and solutions.
40:35.0.1.1.3.5.1.3SECTION 792.90
   792.90 Animal and other test system care.
40:35.0.1.1.3.6SUBPART F
Subpart F - Test, Control, and Reference Substances
40:35.0.1.1.3.6.1.1SECTION 792.105
   792.105 Test, control, and reference substance characterization.
40:35.0.1.1.3.6.1.2SECTION 792.107
   792.107 Test, control, and reference substance handling.
40:35.0.1.1.3.6.1.3SECTION 792.113
   792.113 Mixtures of substances with carriers.
40:35.0.1.1.3.7SUBPART G
Subpart G - Protocol for and Conduct of A Study
40:35.0.1.1.3.7.1.1SECTION 792.120
   792.120 Protocol.
40:35.0.1.1.3.7.1.2SECTION 792.130
   792.130 Conduct of a study.
40:35.0.1.1.3.7.1.3SECTION 792.135
   792.135 Physical and chemical characterization studies.
40:35.0.1.1.3.8SUBPART H
Subparts H-I [Reserved]
40:35.0.1.1.3.9SUBPART J
Subpart J - Records and Reports
40:35.0.1.1.3.9.1.1SECTION 792.185
   792.185 Reporting of study results.
40:35.0.1.1.3.9.1.2SECTION 792.190
   792.190 Storage and retrieval of records and data.
40:35.0.1.1.3.9.1.3SECTION 792.195
   792.195 Retention of records.