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.

• 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.

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

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