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The US Pharmacopeia's revised General Chapters on elemental impurity limits and testing procedures are set to take effect in December 2012, and are to be implemented by the industry by May 2014.
Nov 2, 2012
By:
Katherine Ulman, Neil Schwarzwalder, Andrew Teasdale, David Schoneker, Priscilla Zawislak
The US Pharmacopeia's revised General Chapters on elemental impurity limits and testing procedures are set to take effect in December 2012.
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The authors outline excipient-control strategies and practices for the manufacture, distribution, and receipt of excipients.
Oct 1, 2008
By:
Irwin Silverstein, PhD, Arthur Falk, Dale Carter, MS, Maria Guazzaroni Jacobs, David Schoneker
Securing the integrity of the excipient supply chain is a crucial task in ensuring the overall pharmaceutical supply chain. The authors outline excipient-control strategies and practices for the manufacture, distribution, and receipt of excipients.
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This article presents collaborative positions among excipient manufacturers, drug product manufacturers, and members of the US Pharmacopeia on key issues pertaining to the control of pharmaceutical excipients stemming from a recent Pharmaceutical Quality Research Institute workshop.
Sep 2, 2007
By:
Brian Carlin, Dale Carter, Moira Griffiths, Gregory Larner, Kevin Moore, Barry Rothman, David Schoneker, Catherine Sheehan, Rajendra Uppoor, Phyllis Walsh, Robert Wiens
This article presents collaborative positions among excipient manufacturers, drug product manufacturers, and members of the US Pharmacopeia on key issues pertaining to the control of pharmaceutical excipients stemming from a recent Pharmaceutical Quality Research Institute workshop.
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