CFR section
21 CFR 1271.160(c): Establishment and maintenance of a quality program
PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS · Subpart D-Current Good Tissue Practice
Key facts
| Citation | 21 CFR 1271.160(c) |
|---|---|
| Section | Establishment and maintenance of a quality program |
| Part | PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS |
| Subpart | Subpart D-Current Good Tissue Practice |
| Subchapter | 21 CFR L Other |
| Product types cited | Biologics, Devices, Other_Regulations |
| Regulation text (excerpt) | (c) Audits. You must periodically perform for management review a quality audit, as defined in § 1271.3(gg), of activities related to core CGTP requirements. |
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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.