Current Good Manufacturing Practice for Blood and Blood Components
The FDA (CBER) cGMP for blood and blood components — the organisation, facilities, equipment, production and process controls, labeling, laboratory controls, and records that ensure collected blood and its components are safe, pure, and potent.
Blood establishments that collect, process, store, and distribute blood and blood components for transfusion or further manufacturing.
- 01Maintain written standard operating procedures for all steps
- 02Keep complete, traceable records including look-back where required
- 03Apply production and process controls to collection and processing
- 04Operate laboratory controls for required testing
- 05Report errors and accidents affecting safety, purity, or potency
Long-standing CBER cGMP, updated over time (e.g. 2015 revisions) as testing and safety expectations evolve.
21 CFR Part 606: frequently asked questions
Quick answers to common questions about 21 CFR Part 606.
What is 21 CFR Part 606?
21 CFR Part 606 — Current Good Manufacturing Practice for Blood and Blood Components — is a regulation issued by the Food and Drug Administration (United States). The FDA (CBER) cGMP for blood and blood components — the organisation, facilities, equipment, production and process controls, labeling, laboratory controls, and records that ensure collected blood and its components are safe, pure, and potent.
Who does 21 CFR Part 606 apply to?
Blood establishments that collect, process, store, and distribute blood and blood components for transfusion or further manufacturing.
What are the key requirements of 21 CFR Part 606?
FDA 21 CFR Part 606 requires, among other things: Maintain written standard operating procedures for all steps; Keep complete, traceable records including look-back where required; Apply production and process controls to collection and processing; Operate laboratory controls for required testing.
When was 21 CFR Part 606 last updated?
The current version of 21 CFR Part 606 dates from May 2015. Long-standing CBER cGMP, updated over time (e.g. 2015 revisions) as testing and safety expectations evolve.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When 21 CFR Part 606 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.