21 CFR 606.140 - Laboratory controls.
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Laboratory control procedures shall include:
(a) The establishment of scientifically sound and appropriate specifications, standards and test procedures to assure that blood and blood components are safe, pure, potent and effective.
(b) Adequate provisions for monitoring the reliability, accuracy, precision and performance of laboratory test procedures and instruments.
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.