What 21 CFR Part 606 - Current Good Manufacturing Practice for Blood and Blood Components requires
21 CFR Part 606 establishes the current good manufacturing practice (CGMP) requirements for the collection, processing, compatibility testing, storage and distribution of blood and blood components for transfusion or further manufacturing. Establishments must employ adequate, qualified personnel and maintain suitable facilities, equipment, and supplies and reagents that meet defined standards. They must establish, maintain and follow written standard operating procedures for all steps in the handling of blood and blood components. Laboratory controls must include scientifically sound specifications, standards and test procedures, monitoring of the reliability and accuracy of test procedures and instruments, and accurate identification and handling of test samples. Blood collection establishments and transfusion services must adequately control the risk of bacterial contamination of platelets using FDA-approved or cleared devices or other adequate methods, and must not release contaminated product. Compatibility testing must be performed as required before transfusion. Records must be maintained concurrently with each significant step so that all steps can be clearly traced, and must be retained for the required periods. Establishments must maintain a file of reports of adverse reactions, investigate complaints of adverse reactions, and report product deviations to FDA in accordance with the regulation.
Pillar: Medical & Healthcare · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-606
SHA-256 integrity: 4f4bc2774e190c6d52a88d755c62fca5547ccb0cc4bfc263e2daa5633c0c8800
Primary Citations — 8 traced to source
- 21 CFR Part 606, §606.20 - personnel
- 21 CFR Part 606, §606.40, §606.60 and §606.65 - facilities, equipment, and supplies and reagents
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