New FDA Guidance Assigns Subcontractor Responsibility to Tissue Establishments
Following recent violations of FDA 21 CFR Part 1271.150(c)(1) regulation about human tissues, the administration is publishing guidance “intended to ensure that companies involved in any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of any human cell or tissue, and screening or testing of the cell or tissue donor, are aware of their regulatory responsibilities.”
To the question “Am I responsible for ensuring that establishments that I have manufacturing arrangements with are in compliance with current good tissue practice (CGTP) requirements?”, the guidance answers:
“Yes. If you engage another establishment to perform for you any step in manufacture, that establishment must comply with requirements applicable to that manufacturing step (21 CFR 1271.150(c)(1)(i) and (ii)). Under 21 CFR 1271.150(c)(1)(iii), before entering into a contract, agreement, or other arrangement with another establishment to perform for you any step in manufacture, you must ensure that the establishment complies with applicable CGTP requirements. If, during the course of this contract, agreement, or other arrangement, you become aware of information suggesting that the establishment may no longer be in compliance with such requirements, you must take reasonable steps to ensure the establishment complies with those requirements. If you determine that the establishment is not in compliance with those requirements, you must terminate your contract, agreement, or other arrangement with the establishment.”
The administration has recently formed a task force on human tissue safety.
See also: Human Tissue Handlers Operate Like An Industry.
September 13, 2006 Related topics: Legal & legislative