FDA GLP Inspection Guidance-21 CFR Part 58

 FDA GLP Regulation and GLP Inspection Guidance

21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies

21 CFR Part 58 prescribes good laboratory practices (GLP) for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. Compliance with this part is intended to assure the quality and integrity of the safety data.

Electronic Code of Federal Regulations can be accessed at https://gov.ecfr.io/cgi-bin/text-idx?gp=&SID=5fb3436db739176a247d73e7c69783c9&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl

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
    • https://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/ucm133748.pdf
  • GLP Proposed Rule, 1984
  • GLP Final Rule, 1987
  • GLP Management Briefings 1979
  • CPGM *7348.808 Good Laboratory Practice (Nonclinical Laboratories)
    • https://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/ucm133765.pdf or https://www.fda.gov/media/75891/download
    • *: Compliance Program Guidance Manual
  • FDA BIMO Compliance Program
    • https://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/ucm255614.htm

Last Updated: 2020-06-06