21 CFR 606.100 - Current Good Manufacturing Practice for Blood and Blood Components

What it says

Facilities collecting, processing, storing or distributing blood or blood components must operate under written standard operating procedures covering donor processing, collection, component preparation, storage and distribution, with records demonstrating compliance with these procedures maintained for each unit collected and processed.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This provision represents the US regulatory framework for blood and blood component manufacturing, functioning conceptually parallel to EU GMP Annex 14's treatment of plasma-derived products, though with its own distinct regulatory structure under Part 606 rather than the general Part 211 framework.
• Traceability from individual donation through processing, storage and eventual distribution is a central requirement, similar in principle to the donation-to-batch traceability described under EU GMP Annex 14, given the shared biological origin considerations.
• Donor screening and testing requirements work alongside blood component manufacturing requirements as a connected system, ensuring only appropriately screened donations enter the manufacturing and distribution chain.

What FDA inspectors look for

• Whether records demonstrate genuine traceability for each unit from donation through final distribution or disposition.
• Whether donor screening and testing results are verified and connected to the specific units derived from that donation before those units are released for use.
• Whether standard operating procedures for collection, processing and storage are actually followed as written, with deviations documented and investigated.

Related regulations