21 CFR Part 606: CGMP for blood and blood components
Every unit should be traceable from donor to final disposition, and every step reconstructable from the record. That is what Part 606 is for.
In Short
- Written procedures cover every step, available where work is done.
- Records are concurrent, not filled in later.
- Biological product deviation reports: within 45 calendar days.
The Blood and Tissue Guide
Every unit identified. Every decision reviewed.
- Which rules reach your unit
- Receive, identify, quarantine
- Process, test, review
- Release, label, trace
Plus Evidence map and four worksheets.
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The Blood and Tissue Guide
Every unit identified. Every decision reviewed.
Part 606 sets current good manufacturing practice for blood and blood components. It is law. It works with the general biologics rules (Parts 600 and 610), donor eligibility in Part 630 and component standards in Part 640. This guide covers procedures, records, labeling and deviation reporting. Sections were checked against the eCFR on 2 Oct 2026; donor eligibility guidance changes often, so check FDA's current blood guidance list before relying on any specific deferral criterion.
Who Part 606 applies to
Part 606 applies to blood establishments that collect, process, test, store or distribute blood and blood components, including licensed establishments, unlicensed registered establishments and transfusion services. Licensed establishments also hold a biologics license for products shipped across state lines.
More on who Part 606 applies to
Which reports and submissions apply depends on your status.
Standard Operating Procedures
Section 606.100 requires written standard operating procedures for all steps in collection, processing, compatibility testing, storage and distribution, including donor eligibility, testing, quarantine, labeling, investigation of deviations and handling of returned or recalled products. Procedures must be available where the work is done.
More on standard Operating Procedures
Where Part 640 sets additional standards, SOPs must comply with them.
Records that trace every unit
Section 606.160 requires concurrent records of each significant step, from donor to final disposition, so that every unit can be traced and the work can be reconstructed. Records include donor history and eligibility, test results and interpretations, storage temperatures, distribution and disposition, and adverse reaction and complaint files.
Worked Example: Tracing One Unit
- CollectionDonor eligibility recorded; unit W0000 26 123456 collectedCollection staff
- TestingInfectious disease test results recorded and interpretedLab
- ProcessingRed cells and plasma prepared; each component labelledComponent lab
- StorageStorage temperatures recorded throughoutInventory
- DistributionRed cells issued to hospital H-12; plasma to fractionatorDistribution
More on records that trace every unit
Section 606.165 requires distribution and receipt records that allow tracing to the consignee.
Labeling
Section 606.120 covers labeling controls and the information required on container labels; 606.121 sets content requirements. Many establishments use ISBT 128, the international standard for coding blood, cell and tissue products, maintained by ICCBBA; FDA has recognised its use, but check the current label requirements for each product.
Biological Product Deviation Reports
Under 606.171, licensed manufacturers, unlicensed registered establishments and transfusion services report events that may affect the safety, purity or potency of a distributed product, where the event represents a deviation or an unexpected or unforeseeable event. The report should be made as soon as possible, but no later than 45 calendar days from acquiring information reasonably suggesting a reportable event occurred.
Is this a biological product deviation report?
Simplified examples. Your SOP and FDA guidance decide.
- Distributed product; may affect safety.
- Report within 45 calendar days under 606.171.
More on biological Product Deviation Reports
People decide reportability and record why.
Questions
What is a biological product deviation report?
A report to FDA under 21 CFR 606.171 of an event in manufacturing, holding or distribution that may affect the safety, purity or potency of a distributed blood product. It is due within 45 calendar days of acquiring information reasonably suggesting the event occurred.
Is ISBT 128 required by FDA?
ISBT 128 is a voluntary international standard. FDA's label rules in 21 CFR 606.121 set what labels must contain; FDA has recognised ISBT 128 as a way to meet machine-readable label expectations. Check current FDA guidance for your products.
Where are donor eligibility rules?
Mainly in 21 CFR Part 630, with FDA guidance documents on specific risks. FDA updates these guidances, so check the current list before changing donor criteria.
How long must blood establishment records be kept?
Section 606.160(d) sets the retention periods. Check the current text for each record type.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
21 CFR 1271 Readiness for Tissue and Cell Establishments
AABB Blood Bank Standards and 21 CFR 606 Readiness Guide
CAR T Cell Manufacturing Readiness: Chain of Identity and Release
Cord Blood Bank cGMP Readiness: 1271, BLA and FACT-NetCord
Donor Eligibility, Lookback and Deviation Readiness- EU Tissues and Cells Directive 2004/23/EC and the SoHO Regulation