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May 02, 2015
The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.
April 14, 2015
The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.
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.