CFR section
21 CFR 58.47(b): Facilities for handling test and control articles
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart C-Facilities
Key facts
| Citation | 21 CFR 58.47(b) |
|---|---|
| Section | Facilities for handling test and control articles |
| Part | PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES |
| Subpart | Subpart C-Facilities |
| Subchapter | 21 CFR A General |
| Product types cited | General, Veterinary |
| Regulation text (excerpt) | (b) Storage areas for the test and/or control article and test and control mixtures shall be separate from areas housing the test systems and shall be adequate to preserve the identity, strength, purity, and stability of the articles and mixtures. |
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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.