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April 10, 2015
FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.
April 02, 2015
The Human Microbiome Project has increased our understanding of the relationship between humans and microorganisms. The authors offer a new perspective on how this knowledge should be considered in setting standards for pharmaceutical quality control in microbiology.
March 18, 2015
A new machine is designed for inspection of prefilled syringes.
March 02, 2015
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses good engineering practices.
January 02, 2015
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to handle staff challenges to regulation requirements
December 02, 2014
The author proposes a quality management system that uses the power of executive management to promote a positive quality culture.
November 02, 2014
The parenteral manufacturing industry is taking action to address particulate contamination issues.
October 17, 2014
A selection of articles and news about quality metrics.
October 16, 2014
After almost two years of anticipation, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), has administration approval for organizational changes to bolster programs and policies to ensure drug quality.
October 10, 2014
The European Medicines Agency releases highlights from its Pharmacovigilance Risk Assessment Committee safety review meeting in October.