CFR section
21 CFR 1271.150(c)(1)(iii): Current good tissue practice requirements
PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS · Subpart D-Current Good Tissue Practice
Key facts
| Citation | 21 CFR 1271.150(c)(1)(iii) |
|---|---|
| Section | Current good tissue practice requirements |
| 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 | Devices, Drugs, Other_Regulations |
| Regulation text (excerpt) | (iii) Before entering into a contract, agreement, or other arrangement with another establishment to perform any step in manufacture for you, you must ensure that the establishment complies with applicable CGTP requirements. If, during the course of this contract, agreement, or other arrangement, you become aware of information suggesting that the establishment may no longer be in compliance with such requirements, you must take reasonable steps to ensure the establishment complies with those… |
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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.