Title 40

PART 160

Part 160 - Good Laboratory Practice Standards

PART 160 - GOOD LABORATORY PRACTICE STANDARDS Authority:7 U.S.C. 136a, 136c, 136d, 136f, 136j, 136t, 136v, 136w; 21 U.S.C. 346a, 371, Reorganization Plan No. 3 of 1970. Source:54 FR 34067, Aug. 17, 1989, unless otherwise noted.

40:26.0.1.1.11.1SUBPART A
Subpart A - General Provisions
40:26.0.1.1.11.1.1.1SECTION 160.1
   160.1 Scope and applicability.
40:26.0.1.1.11.1.1.2SECTION 160.3
   160.3 Definitions.
40:26.0.1.1.11.1.1.3SECTION 160.10
   160.10 Applicability to studies performed under grants and contracts.
40:26.0.1.1.11.1.1.4SECTION 160.12
   160.12 Statement of compliance or non-compliance.
40:26.0.1.1.11.1.1.5SECTION 160.15
   160.15 Inspection of a testing facility.
40:26.0.1.1.11.1.1.6SECTION 160.17
   160.17 Effects of non-compliance.
40:26.0.1.1.11.2SUBPART B
Subpart B - Organization and Personnel
40:26.0.1.1.11.2.1.1SECTION 160.29
   160.29 Personnel.
40:26.0.1.1.11.2.1.2SECTION 160.31
   160.31 Testing facility management.
40:26.0.1.1.11.2.1.3SECTION 160.33
   160.33 Study director.
40:26.0.1.1.11.2.1.4SECTION 160.35
   160.35 Quality assurance unit.
40:26.0.1.1.11.3SUBPART C
Subpart C - Facilities
40:26.0.1.1.11.3.1.1SECTION 160.41
   160.41 General.
40:26.0.1.1.11.3.1.2SECTION 160.43
   160.43 Test system care facilities.
40:26.0.1.1.11.3.1.3SECTION 160.45
   160.45 Test system supply facilities.
40:26.0.1.1.11.3.1.4SECTION 160.47
   160.47 Facilities for handling test, control, and reference substances.
40:26.0.1.1.11.3.1.5SECTION 160.49
   160.49 Laboratory operation areas.
40:26.0.1.1.11.3.1.6SECTION 160.51
   160.51 Specimen and data storage facilities.
40:26.0.1.1.11.4SUBPART D
Subpart D - Equipment
40:26.0.1.1.11.4.1.1SECTION 160.61
   160.61 Equipment design.
40:26.0.1.1.11.4.1.2SECTION 160.63
   160.63 Maintenance and calibration of equipment.
40:26.0.1.1.11.5SUBPART E
Subpart E - Testing Facilities Operation
40:26.0.1.1.11.5.1.1SECTION 160.81
   160.81 Standard operating procedures.
40:26.0.1.1.11.5.1.2SECTION 160.83
   160.83 Reagents and solutions.
40:26.0.1.1.11.5.1.3SECTION 160.90
   160.90 Animal and other test system care.
40:26.0.1.1.11.6SUBPART F
Subpart F - Test, Control, and Reference Substances
40:26.0.1.1.11.6.1.1SECTION 160.105
   160.105 Test, control, and reference substance characterization.
40:26.0.1.1.11.6.1.2SECTION 160.107
   160.107 Test, control, and reference substance handling.
40:26.0.1.1.11.6.1.3SECTION 160.113
   160.113 Mixtures of substances with carriers.
40:26.0.1.1.11.7SUBPART G
Subpart G - Protocol for and Conduct of a Study
40:26.0.1.1.11.7.1.1SECTION 160.120
   160.120 Protocol.
40:26.0.1.1.11.7.1.2SECTION 160.130
   160.130 Conduct of a study.
40:26.0.1.1.11.7.1.3SECTION 160.135
   160.135 Physical and chemical characterization studies.
40:26.0.1.1.11.8SUBPART H
Subparts H-I [Reserved]
40:26.0.1.1.11.9SUBPART J
Subpart J - Records and Reports
40:26.0.1.1.11.9.1.1SECTION 160.185
   160.185 Reporting of study results.
40:26.0.1.1.11.9.1.2SECTION 160.190
   160.190 Storage and retrieval of records and data.
40:26.0.1.1.11.9.1.3SECTION 160.195
   160.195 Retention of records.