CFR section
21 CFR 58.81(c): Standard operating procedures
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart E-Testing Facilities Operation
Key facts
| Citation | 21 CFR 58.81(c) |
|---|---|
| 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, Food/Cosmetics, General |
| Regulation text (excerpt) | (c) Each laboratory area shall have immediately available laboratory manuals and standard operating procedures relative to the laboratory procedures being performed. Published literature may be used as a supplement to standard operating procedures. |
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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.