21 CFR 1271 Subpart D - Current Good Tissue Practice for Human Cells, Tissues, and Cellular and Tissue-Based Products

What it says

Establishments that manufacture human cells, tissues, or cellular and tissue-based products must comply with current good tissue practice requirements, including donor eligibility determination, facility and environmental controls appropriate to prevent contamination and communicable disease transmission, process controls, and tracking sufficient to trace a product from donor through distribution.

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

What it means in practice

• This framework addresses a distinct regulatory category from both traditional drug cGMP and device QMSR, specifically tailored to the unique risks of human-derived cell and tissue products, most centrally the risk of communicable disease transmission from donor to recipient.
• Donor eligibility determination, including donor screening and testing for relevant communicable disease agents, is a foundational and specific control point with no direct equivalent in synthetic drug or device manufacturing, reflecting the product's direct human biological origin.
• Tracking requirements mirror the traceability principles seen in blood and plasma product regulation, requiring the ability to trace a specific product from its originating donor through processing and distribution to its ultimate recipient or disposition.

What FDA inspectors look for

• Whether donor eligibility determination, including required screening and testing, is completed and documented before tissue is released for further processing or distribution.
• Whether tracking systems can genuinely trace a specific product from donor through to final distribution or disposition.
• Whether facility and environmental controls are appropriate to prevent contamination and communicable disease transmission risk specific to human cell and tissue processing.

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