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May 30, 2014
A drug sponsor?s responsibility does not end when a task is outsourced.
May 08, 2014
Life-sciences companies can get a jump on potential quality problems by looking at the leading indicators hiding in the document management process further upstream.
May 02, 2014
Industry players offer suggestions for quality metrics as FDA continues to try and solve the problem of drug shortages.
January 02, 2014
This article takes a statistical look at the calibration requirements for a UV spectrometer.
December 04, 2013
PharmaCheck, a portable tool designed to detect poor-quality medicines, has been selected by Scientific American as one of the magazine?s World Changing Ideas of 2013.
November 20, 2013
An operational-excellence initiative increased collaboration between operations and quality personnel to address human-error-caused deviations.
November 02, 2013
Siegfried Schmitt of PAREXEL discusses regulation requirements for quality systems.
October 02, 2013
Recent FDA enforcement activity reveals issues with vial-filling, adequacy of QA/QC procedures, particulate matter in inhalation powders and injectables, and drug labeling.
September 02, 2013
How good is a reportable value?
August 01, 2013
Recent draft guidance from FDA on contract manufacturing and quality agreements highlights the importance of such agreements and define the roles and responsibilities of each party to be in keeping with quality risk-management principles.