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.
What this does not cover
stated in the document's own scope- Covers cGMP for blood and blood components; donor eligibility and the general requirements for blood establishments are set in 21 CFR Part 630.
- Governs manufacturing and processing controls, not the general biological-product standards and release testing, which are in 21 CFR Part 610.
- Applies to blood and blood components, not to human tissues, which fall under the HCT/P framework in 21 CFR Part 1271.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
21 CFR Part 606 is the FDA current good manufacturing practice regulation for blood and blood components. It applies the cGMP concept to the collection and processing of whole blood and components such as red cells, plasma, and platelets, covering organisation and personnel, plant and facilities, equipment, production and process controls, laboratory controls, finished-product labeling, and records and reports. The objective is that each unit of blood or component intended for transfusion or further manufacture is safe, pure, and potent, with a complete record trail from collection through distribution.
Scope & applicability
Blood establishments that collect, process, store, and distribute blood and blood components for transfusion or further manufacturing.
Legal basis & how it acquires force
Part 606 is a binding regulation in Title 21 CFR, administered by the Center for Biologics Evaluation and Research. Blood and blood components are biological products, so the regulation operates under both the Public Health Service Act licensing framework for biologics and the Federal Food, Drug, and Cosmetic Act. It works together with the related blood regulations — the Part 600-series general biologics provisions, Part 610 general biological-product standards, and Part 630 on donor eligibility and requirements for blood establishments.
Document structure
| Part | Covers |
|---|---|
| Organization and personnel | Structure, responsibilities, and qualification of personnel at the blood establishment |
| Plant and facilities | Suitable premises for collection and processing operations |
| Equipment | Equipment observation, standardization, and calibration |
| Production and process controls | Standard operating procedures for collection, processing, and component preparation |
| Laboratory controls | Testing and control of blood and components before release |
| Records, reports, and labeling | Finished-product labeling and the records and reports maintained |
Key requirements
- 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
- Report errors and accidents affecting safety, purity, or potency
Implementation tips
- Keep SOPs current and followed — §606.100 findings are among the most common
- Build records for full traceability and look-back; gaps surface during recalls
- Treat testing and process controls as release-critical for component safety
Revision notes
Long-standing CBER cGMP, updated over time (e.g. 2015 revisions) as testing and safety expectations evolve.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Part 606 is one member of the FDA blood-regulation family: it supplies the cGMP, Part 630 covers donor eligibility and the requirements for blood establishments, Part 610 sets general biological-product standards including testing, and the Part 600-series carries the general biologics licensing provisions. Together they implement the safe, pure, and potent standard for biologics under the PHS Act. It is a US blood regulation and not part of the ICH/PIC/S drug-GMP harmonisation scheme.
21 CFR Part 606: frequently asked questions
Quick answers to common questions about 21 CFR Part 606.
What does 21 CFR Part 606 cover?
The current good manufacturing practice for blood and blood components — organisation and personnel, facilities, equipment, production and process controls, laboratory controls, labeling, and records — so that each unit is safe, pure, and potent.
Is blood regulated as a biologic?
Yes. Blood and blood components are biological products, so Part 606 operates under the Public Health Service Act biologics framework as well as the Federal Food, Drug, and Cosmetic Act, and is administered by the Center for Biologics Evaluation and Research.
Where are donor-eligibility requirements found?
Not in Part 606. Donor eligibility and the general requirements for blood establishments are set out in 21 CFR Part 630; Part 606 focuses on the cGMP for collection and processing.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.