CFR section
21 CFR 58.195(d): Retention of records
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart J-Records and Reports
Key facts
| Citation | 21 CFR 58.195(d) |
|---|---|
| Section | Retention of records |
| Part | PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES |
| Subpart | Subpart J-Records and Reports |
| Subchapter | 21 CFR A General |
| Product types cited | General |
| Regulation text (excerpt) | (d) The master schedule sheet, copies of protocols, and records of quality assurance inspections, as required by § 58.35(c) shall be maintained by the quality assurance unit as an easily accessible system of records for the period of time specified in paragraphs (a) and (b) of 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.