CFR section
21 CFR 680.1(b)(2)(iii): Allergenic Products
PART 680-ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS
Key facts
| Citation | 21 CFR 680.1(b)(2)(iii) |
|---|---|
| Section | Allergenic Products |
| Part | PART 680-ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Drugs |
| Regulation text (excerpt) | (iii) Mold manufacturers shall maintain written standard operating procedures, developed by a qualified individual, that will ensure the identity of the seed culture, prescribe adequate processing of the mold, and specify the acceptable limits and kinds of contamination. These limits shall be based on results of appropriate tests performed by the manufacturer on at least three consecutive lots of a mold that is a representative species of mold subject to the standard operating procedures. The… |
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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.