• 21 CFR 58 - Good Laboratory Practice
  • 21 CFR Part 58 - LII / Legal Information Institute
  • No entries appear in the Federal Register after this date, for 21 CFR Part 58
  • 21 CFR 58 - Good Laboratory Practice

Compact Regs Part 58: CFR 21 Part 58 Good Laboratory Practice for Non-clinical Laboratory Studies 10 Pack, Second Edition

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It is important to note that for morphometric analysis of printed or digital pathology images from slide-based specimens, it is not enough to archive the slide-based specimen because the data generation was actually based on the image, not the slide. The cells or tissues on the glass slide are retained as GLP-specified retained specimens (21 CFR Part 58, Section 58.190[a]); the slides are not raw data.

During routine inspections and investigations conducted at any regulated entity that has a written quality assurance program, FDA will not review or copy reports and records that result from audits and inspections of the written quality assurance program, including audits conducted under 21 CFR *820.22* and written status reports required by 21 CFR 58.35(b)(4).


21 CFR Part 11, 21 CFR Part 58, 21 CFR Parts 210/211, 21 CFR Part 820