21 CFR § 606.140 - Laboratory controls.

---
identifier: "/us/cfr/t21/s606.140"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 606.140 - Laboratory controls."
title_number: 21
title_name: "Food and Drugs"
section_number: "606.140"
section_name: "Laboratory controls."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "F"
subchapter_name: "BIOLOGICS"
part_number: "606"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 355, 360, 360j, 371, 374; 42 U.S.C. 216, 262, 263a, 264."
regulatory_source: "40 FR 53532, Nov. 18, 1975, unless otherwise noted."
cfr_part: "606"
---


# 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.