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Last Updated Tuesday, August 19 2014
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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 Dilip M. Parikh
Published August 22, 2005
Outsourcing offers companies a new option in this regulatory process. Read More »
Injectables CMOs Stay Ahead of Complexity
By Kristin Brooks , Contract Pharma
Published April 3, 2014
Biologics and cytotoxic processes are pushing demand for specialized contract services, especially from small-to-midsized companies. Read More »
Reducing the Risk of Delamination
By Bernhard Hladik , SCHOTT Pharmaceutical Systems
Published April 3, 2014
Why it happens and ways to solve the problem Read More »
FDA’s Quality Agreement Guidance Vs. EMA’s cGMP Regulations
By John Avellanet, Cerulean Associates LLC
Published October 9, 2013
Can you comply with both? Read More »
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