FDA Issues HCT/P Guidance
Less than a year after the FDA's new donor screening and testing regulations became effective in May 2005, there were 77 HCT/P deviations reported to the agency. So, it was not much of a surprise that the FDA recently issued a guidance pertaining to certain HCT/Ps (human cell, tissue, and cellular and tissue-based products).The guidance, released on Jan. 23, addresses certain HCT/Ps (namely, hematopoietic stem cells and reproductive cells and tissues) that were tested for communicable diseases using pooled specimens or diagnostic tests. The FDA said it has learned that some testing laboratories that perform communicable disease testing on donors of HCT/Ps have failed to comply with Current Good Tissue Practice (CGTP) requirements found in 21 CFR Part 1271, Subpart C.
The FDA identified two categories of compliance problems:
If this guidance is applicable to your laboratory, here are some of the things you need to consider.
- Some laboratories, apparently familiar with pooling instructions for blood and plasma donor specimens, performed Nucleic Acid Testing (NAT) for human immunodeficiency virus, type 1 (HIV-1) and hepatitis C virus (HCV) on pooled HCT/P donor specimens, even though the manufacturer's instructions (package inserts) for the NAT tests specified that testing be performed on individual HCT/P donor specimens.
- Some test laboratories used diagnostic tests to test HCT/P donor specimens rather than the FDA-licensed donor screening tests required by 21 CFR 1271.80(c).
1. Quarantine Affected HCT/Ps. Establishments should identify, quarantine, and not distribute HCT/Ps currently in inventory that were obtained from donors tested using pooled specimens or diagnostic tests.
2. Conduct CAPA Investigation. Any establishment that performed donor testing subject to one of the two deficiencies must investigate those deficiencies and ensure that appropriate corrective/preventive actions have been taken. Establishments that contracted donor testing to an outside laboratory are deemed responsible for conducting CAPA investigations.
3. Report HCT/P Deviations. Under 21 CFR 1271.350(b)(2), you must report any HCT/P deviation relating to a core CGTP requirement, if the HCT/P deviation occurred in your facility or in a facility that performed a manufacturing step for you under contract. Read the guidance for specific HCT/Ps that would require deviation reporting.
Read other articles relevant to the blood, tissue, and biologics industry:
- 2007 Guidance Pertaining to Certain HCT/Ps