CFR section
21 CFR 1271.47(e): What procedures must I establish and maintain?
PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS · Subpart C-Donor Eligibility
Key facts
| Citation | 21 CFR 1271.47(e) |
|---|---|
| Section | What procedures must I establish and maintain? |
| Part | PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS |
| Subpart | Subpart C-Donor Eligibility |
| Subchapter | 21 CFR L Other |
| Product types cited | Other_Regulations |
| Regulation text (excerpt) | (e) Standard procedures. You may adopt current standard procedures, such as those in a technical manual prepared by another organization, provided that you have verified that the procedures are consistent with and at least as stringent as the requirements of this part and appropriate for your operations. |
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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.