GMP Tips - FDA Issues New Guidance on CGTP - Sept 20, 2006

The Food and Drug Administration (FDA) is reminding companies that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) that they must comply with FDA regulations. A new Guidance for Industry: Compliance with 21CFR Part 1271.150(c)(1) – Manufacturing Arrangements was issued on September 8, 2006. (Don’t you just love the memorable titles FDA gives to these documents?)

The issuance of the guidance to industry follows two recently identified cases of serious violations of safety requirements pertaining to the recovery of tissues, and subsequent FDA actions to stop the operations.

"Patient safety is our primary concern," said Jesse Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research (CBER). "This guidance serves to emphasize the important role that manufacturers play in enhancing tissue safety by helping to ensure that those that perform work for them also comply with the regulations.

CGTP is Current Good Tissue Practices introduced in 2005.

Read this new guidance document. Go to:
http://www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

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