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Ensuring Drug Quality in a Global Economy
By Helena Champion , Principal Consultant, Drug Quality Assurance LLC
Published May 1, 2014
Offshore CMO’s have proven a weak link in pharma’s supply chain. Will recent quality problems in India and China increase oversight? 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 »
Published March 25, 2013
A filing with the FDA to gain approval of a major change that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of… Read More »
Implementing Process Validation Guidances
By Peter H. Calcott, Ph.D., President, Calcott Consulting LLC
Published March 6, 2013
Complying with FDA and EU for small and mid-sized companies Read More »
By Colleen Heisey, J.D., M.P.H. and Sharon M. Bradley, J.D., Hunton & Williams LLP
Published November 9, 2012
Self-identification under the Generic Drug User Fee Amendments Read More »
By Stephen Barlas
Published March 7, 2011
Fireworks fly as FDA discusses track and trace Read More »
Drug Packaging Serialization
By Stephen Barlas
Published June 1, 2010
A new FDA final guidance jump-starts track and trace Read More »
Generic Preformulation of Drug in Adhesive Patches
By Mike Bly, Ph.D.
Published March 4, 2009
New delivery forms create new challenges Read More »
By Kevin O'Donnell
Published July 18, 2008
Storage vs. shipping and the vagaries of regulatory requirements Read More »
Aseptic Process Validation
By Tom Spurgeon
Published November 3, 2006
Is a new FDA guidance imminent? Read More »
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