GMP Tips - FDA Revises Drug GMP - Sept 15, 2008

Last week FDA issued a Final Rule titled “Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals.” The rule revises CGMP requirements primarily for aseptic processing, the use of asbestos filters, and the verification of performance operations by a second individual. This Amendment is scheduled to go into effect on December 8, 2008.

Download a copy of the Amendments. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

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