Source: https://regulatorydoctor.us/fda-glp-inspection-guidance-21-cfr-part-58/
Timestamp: 2019-04-22 15:18:35+00:00

Document:
§ 58.10 – Applicability to studies performed under grants and contracts.
§ 58.15 – Inspection of a testing facility.
§ 58.31 – Testing facility management.
§ 58.33 – Study director.
§ 58.35 – Quality assurance unit.
§ 58.43 – Animal care facilities.
§ 58.45 – Animal supply facilities.
§ 58.47 – Facilities for handling test and control articles.
§ 58.49 – Laboratory operation areas.
§ 58.51 – Specimen and data storage facilities.
§ 58.61 – Equipment design.
§ 58.63 – Maintenance and calibration of equipment.
§ 58.81 – Standard operating procedures.
§ 58.83 – Reagents and solutions.
§ 58.90 – Animal care.
§ 58.105 – Test and control article characterization.
§ 58.107 – Test and control article handling.
§ 58.113 – Mixtures of articles with carriers.
§ 58.130 – Conduct of a nonclinical laboratory study.
§ 58.185 – Reporting of nonclinical laboratory study results.
§ 58.190 – Storage and retrieval of records and data.
§ 58.195 – Retention of records.
§ 58.202 – Grounds for disqualification.
§ 58.204 – Notice of and opportunity for hearing on proposed disqualification.
§ 58.206 – Final order on disqualification.
§ 58.210 – Actions upon disqualification.
§ 58.213 – Public disclosure of information regarding disqualification.
§ 58.215 – Alternative or additional actions to disqualification.
§ 58.217 – Suspension or termination of a testing facility by a sponsor.
§ 58.219 – Reinstatement of a disqualified testing facility.

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