CFR section
21 CFR 640.25(b): General requirements
PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS · Subpart C-Platelets
Key facts
| Citation | 21 CFR 640.25(b) |
|---|---|
| Section | General requirements |
| Part | PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS |
| Subpart | Subpart C-Platelets |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Devices, Drugs, Other_Regulations |
| Regulation text (excerpt) | (b) Quality control testing. Each month four units prepared from different donors shall be tested at the end of the storage period as follows: (1) Platelet count. (2) pH of not less than 6.2 measured at the storage temperature of the unit. (3) Measurement of actual plasma volume. (4) If the results of the quality control testing indicate that the product does not meet the prescribed requirements, immediate corrective action shall be taken and a record maintained of such action. |
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