Good Laboratory Practice for Nonclinical Studies

Introduction

1. Subpart A - General Provisions

i) Sec. 58.1 Scope

ii) Sec. 58.3 Definitions.

iii) Sec. 58.10 Applicability to studies performed under grants and contracts.

iv) Sec. 58.15 Inspection of a testing facility.

2. Subpart B - Organization and Personnel

i) Sec. 58.29 Personnel.

ii) Sec. 58.31 Testing facility management.

iii) Sec. 58.33 Study director

iv) Sec. 58.35 Quality assurance unit.

3. Subpart C - Facilities

i) Sec. 58.41 General.

ii) Sec. 58.43 Animal care facilities.

iii) Sec. 58.45 Animal supply facilities.

iv) Sec. 58.47 Facilities for handling test and control articles.

v) Sec. 58.49 Laboratory operation areas

vi) Sec. 58.51 Specimen and data storage facilities

4. Subpart D - Equipment

i) Sec. 58.61 Equipment design.

ii) Sec. 58.63 Maintenance and calibration of equipment.

5. Subpart E - Testing Facilities Operation

i) Sec. 58.81 Standard operating procedures.

ii) Sec. 58.83 Reagents and solutions.

iii) Sec. 58.90 Animal care.

6. Subpart F - Test and Control Articles

i) Sec. 58.107 Test and control article handling.

ii) Sec. 58.113 Mixtures of articles with carriers.

7. Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study

i) Sec. 58.120 Protocol.

ii) Sec. 58.130 Conduct of a nonclinical laboratory study.

8. Subpart J - Records and Reports

i) Sec. 58.185 Reporting of nonclinical laboratory study results.

ii) Sec. 58.190 Storage and retrieval of records and data.

9. Subpart K - Disqualification of Testing Facilities i) Sec. 58.200 Purpose.

ii) Sec. 58.202 Grounds for disqualification.

iii) Sec. 58.204 Notice of and opportunity for hearing on proposed disqualification.

iv) Sec. 58.210 Actions upon disqualification.

v) Sec. 58.213 Public disclosure of information regarding disqualification.

vi) Sec. 58.217 Suspension or termination of a testing facility by a sponsor.

vii) Sec. 58.219 Reinstatement of a disqualified testing facility.

10. Data Integrity: Paper and Electronic 21CFR11