C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER F—BIOLOGICS › PART 606—CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS › Subpart H—Laboratory Controls

21 C.F.R. § 606.140

Laboratory controls

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

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.

Notes of Decisions
Cited in 1 case, 1998–1998 · leading case: Luckey v. Baxter Healthcare Corp., 2 F. Supp. 2d 1034 (N.D. Ill. 1998).
Sort: Relevance Newest Treatment
Luckey v. Baxter Healthcare Corp., 2 F. Supp. 2d 1034 (N.D. Ill. 1998). “” 21 C.F.R. § 606.140 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.”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.