CFR section
21 CFR 58.41: General
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart C-Facilities
Key facts
| Citation | 21 CFR 58.41 |
|---|---|
| Section | General |
| Part | PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES |
| Subpart | Subpart C-Facilities |
| Subchapter | 21 CFR A General |
| Product types cited | General |
| Regulation text (excerpt) | Each testing facility shall be of suitable size and construction to facilitate the proper conduct of nonclinical laboratory studies. It shall be designed so that there is a degree of separation that will prevent any function or activity from having an adverse effect on the study. |
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Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.