CFR section
21 CFR 58.81(a): Standard operating procedures
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart E-Testing Facilities Operation
Key facts
| Citation | 21 CFR 58.81(a) |
|---|---|
| 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) | (a) A testing facility shall have standard operating procedures in writing setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. All deviations in a study from standard operating procedures shall be authorized by the study director and shall be documented in the raw data. Significant changes in established standard operating procedures shall be properly authorized in writing… |
At a glance
- 10–99 Inspections citing this section
- 1–9 Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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.