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Published July 22, 2014
Will produce NME for U.S. market Read More »
FDA Aseptic Inspections Will Focus on Process, FDA’s Friedman Says
Published March 27, 2014
At a PDA conference track at Interphex 2014, FDA’s Richard Friedman, Associate DirectorAssociate Director of FDA’s Office of Manufacturing and Product Quality at the Center for Drug Evaluation and Research’s Office of Compliance, discussed changes in the way FDA inspectors will review aseptic facilities. The emphasis now, he says, will be on day to day process operations and control. Read More »
By Ed Silverman, Contributing Editor
Published November 13, 2013
Can FDA get tough? Read More »
Published October 22, 2013
Audits demonstrate custom manufacturing capabilities Read More »
Global API Inspections
By Tony Scott, European Fine Chemicals Group
Published January 22, 2013
Can Mutual Recognition Agreements ensure safety? Read More »
Are You Gambling With Your Next Inspection?
By Julie Larsen, BioTeknica, Inc.
Published November 9, 2012
10 Key Questions to Assess Inspection Readiness Read More »
By Gil Roth
Published July 27, 2011
Synthesis sites in France, Bahamas pass muster Read More »
Quality Assurance Inspections
By Philippe Ourisson
Published September 13, 2006
Key elements of the laboratory auditing process Read More »
By Dilip M. Parikh
Published August 22, 2005
Outsourcing offers companies a new option in this regulatory process. Read More »
Published July 10, 2014
To offer Eyecon to support real-time in-line characterization Read More »
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