CFR section
21 CFR 58.105(a): Test and control article characterization
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart F-Test and Control Articles
Key facts
| Citation | 21 CFR 58.105(a) |
|---|---|
| Section | Test and control article characterization |
| Part | PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES |
| Subpart | Subpart F-Test and Control Articles |
| Subchapter | 21 CFR A General |
| Product types cited | General, Veterinary |
| Regulation text (excerpt) | (a) The identity, strength, purity, and composition or other characteristics which will appropriately define the test or control article shall be determined for each batch and shall be documented. Methods of synthesis, fabrication, or derivation of the test and control articles shall be documented by the sponsor or the testing facility. In those cases where marketed products are used as control articles, such products will be characterized by their labeling. |
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