Title 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND
HUMAN SERVICES

PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

TEXT PDF58.1 Scope.
TEXT PDF58.3 Definitions.
TEXT PDF58.10 Applicability to studies performed under grants and contracts.
TEXT PDF58.15 Inspection of a testing facility.
TEXT PDF58.29 Personnel.
TEXT PDF58.31 Testing facility management.
TEXT PDF58.33 Study director.
TEXT PDF58.35 Quality assurance unit.
TEXT PDF58.41 General.
TEXT PDF58.43 Animal care facilities.
TEXT PDF58.45 Animal supply facilities.
TEXT PDF58.47 Facilities for handling test and control articles.
TEXT PDF58.49 Laboratory operation areas.
TEXT PDF58.51 Specimen and data storage facilities.
TEXT PDF58.61 Equipment design.
TEXT PDF58.63 Maintenance and calibration of equipment.
TEXT PDF58.81 Standard operating procedures.
TEXT PDF58.83 Reagents and solutions.
TEXT PDF58.90 Animal care.
TEXT PDF58.105 Test and control article characterization.
TEXT PDF58.107 Test and control article handling.
TEXT PDF58.113 Mixtures of articles with carriers.
TEXT PDF58.120 Protocol.
TEXT PDF58.130 Conduct of a nonclinical laboratory study.
TEXT PDF58.185 Reporting of nonclinical laboratory study results.
TEXT PDF58.190 Storage and retrieval of records and data.
TEXT PDF58.195 Retention of records.
TEXT PDF58.200 Purpose.
TEXT PDF58.202 Grounds for disqualification.
TEXT PDF58.204 Notice of and opportunity for hearing on proposed disqualification.
TEXT PDF58.206 Final order on disqualification.
TEXT PDF58.210 Actions upon disqualification.
TEXT PDF58.213 Public disclosure of information regarding disqualification.
TEXT PDF58.215 Alternative or additional actions to disqualification.
TEXT PDF58.217 Suspension or termination of a testing facility by a sponsor.
TEXT PDF58.219 Reinstatement of a disqualified testing facility.

--------------------------------------------------------------------- -----------

[BACK ][BACK ]