FDA GLP Inspection Guidance-21 CFR Part 58

 FDA GLP Inspection Guidance

21 CFR Part 58 Good Laboratory Practice

Subpart A–General Provisions 
§ 58.1 – Scope.
§ 58.3 – Definitions.
§ 58.10 – Applicability to studies performed under grants and contracts.
§ 58.15 – Inspection of a testing facility.

Subpart B–Organization and Personnel 
§ 58.29 – Personnel.
§ 58.31 – Testing facility management.
§ 58.33 – Study director.
§ 58.35 – Quality assurance unit.

Subpart C–Facilities 
§ 58.41 – General.
§ 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.

Subpart D–Equipment 
§ 58.61 – Equipment design.
§ 58.63 – Maintenance and calibration of equipment.

Subpart E–Testing Facilities Operation 
§ 58.81 – Standard operating procedures.
§ 58.83 – Reagents and solutions.
§ 58.90 – Animal care.

Subpart F–Test and Control Articles 
§ 58.105 – Test and control article characterization.
§ 58.107 – Test and control article handling.
§ 58.113 – Mixtures of articles with carriers.

Subpart G–Protocol for and Conduct of a Nonclinical Laboratory Study 
§ 58.120 – Protocol.
§ 58.130 – Conduct of a nonclinical laboratory study.

Subparts H-I [Reserved]

Subpart J–Records and Reports 
§ 58.185 – Reporting of nonclinical laboratory study results.
§ 58.190 – Storage and retrieval of records and data.
§ 58.195 – Retention of records.

Subpart K–Disqualification of Testing Facilities 
§ 58.200 – Purpose.
§ 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.

FDA Good Laboratory Practice (GLP) Inspection Guidance

  • GLP Questions and Answers, 2000
  • GLP Proposed Rule, 1984
  • GLP Final Rule, 1987
  • GLP Management Briefings 1979

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Last Updated: 2015-07-02