Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024
§ 606.140 - Laboratory controls.

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.

(c) Adequate identification and handling of all test samples so that they are accurately related to the specific unit of product being tested, or to its donor, or to the specific recipient, where applicable.

source: 40 FR 53532, Nov. 18, 1975, unless otherwise noted.
cite as: 21 CFR 606.140