CFR section
21 CFR 606.65(c): Supplies and reagents
PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS · Subpart D-Equipment
Key facts
| Citation | 21 CFR 606.65(c) |
|---|---|
| Section | Supplies and reagents |
| Part | PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS |
| Subpart | Subpart D-Equipment |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Drugs |
| Regulation text (excerpt) | (c) Representative samples of each lot of the following reagents or solutions shall be tested on a regularly scheduled basis by methods described in the Standard Operating Procedures Manual to determine their capacity to perform as required: Reagent or solution Frequency of testing Anti-human globulin Each day of use. Blood grouping reagents Do. Lectins Do. Antibody screening and reverse grouping cells Do. Hepatitis test reagents Each run. Syphilis serology reagents Do. Enzymes Each day of use. |
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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.