CFR section
21 CFR 58.35(b)(5): Quality assurance unit
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart B-Organization and Personnel
Key facts
| Citation | 21 CFR 58.35(b)(5) |
|---|---|
| Section | Quality assurance unit |
| Part | PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES |
| Subpart | Subpart B-Organization and Personnel |
| Subchapter | 21 CFR A General |
| Product types cited | Drugs, General |
| Regulation text (excerpt) | (5) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. |
At a glance
- 10–99 Inspections citing this section
- 1–9 Warning letters citing this section
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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.