part_subject: "CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS"
subpart_code: "H"
subpart_subject: "Laboratory Controls"
section_number: "606.140"
section_subject: "Laboratory controls."
cfr_reference: "21 CFR 606.140"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 600 to 799"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
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.