CFR section
21 CFR 58.49: Laboratory operation areas
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart C-Facilities
Key facts
| Citation | 21 CFR 58.49 |
|---|---|
| Section | Laboratory operation areas |
| 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) | Separate laboratory space shall be provided, as needed, for the performance of the routine and specialized procedures required by nonclinical laboratory studies. |
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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.