CFR section
21 CFR 58.81(b): Standard operating procedures
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart E-Testing Facilities Operation
Key facts
| Citation | 21 CFR 58.81(b) |
|---|---|
| Section | Standard operating procedures |
| Part | PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES |
| Subpart | Subpart E-Testing Facilities Operation |
| Subchapter | 21 CFR A General |
| Product types cited | Drugs, General, Veterinary |
| Regulation text (excerpt) | (b) Standard operating procedures shall be established for, but not limited to, the following: (1) Animal room preparation. (2) Animal care. (3) Receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles. (4) Test system observations. (5) Laboratory tests. (6) Handling of animals found moribund or dead during study. (7) Necropsy of animals or postmortem examination of animals. (8) Collection and identification of specimens. (9) Histopathology… |
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About CFR sections cited by the FDA
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.