Event Detail
USP – Chapter 467 & GMP Requirements for Testing Residual Solvents
September 9, 2009
- Online
BenAstrum Pharma Broad
ardy.heydari@benastrum.com
Phone: (514) 337-1616
Fax: (514) 337-8803
Learning Benefits: -How do the USP Class I, II and III definitions of residual solvents impact your residual solvent testing requirements? -To what extent can supplier certification be used in lieu of residual solvent testing? -How to effectively navigate the USP <467> Residual Solvent flowchart to minimize testing -How to choose and validate the analytical methods for testing residual solvents -How to set residual solvent specifications and how to evaluate the data against the limits -How to report residual solvent data for products marketed under NDAs and ANDAs -How to report data for pharmaceutical products which are not marketed under NDAs/ANDAs -Additional information provided by the Office of Generic Drugs