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QA/QC

 

NMR spectroscopy: a superior tool for quality control of pharmaceutical products

28 October 2014 | By Torgny Rundlöf, Pharmaceutical Evaluator, Medical Products Agency, Sweden

Pharmaceutical products have to be of high quality with respect to a number of predefined attributes, e.g. identity and strength with respect to the active pharmaceutical ingredient (API) and the presence and levels of impurities. At least for smaller compounds, such quality control often involves chromatographic methods. The examples given…

Lean, Six Sigma, people and organisations

5 September 2014 | By Dr. Stephen McGrath, Teva Pharmaceuticals Ireland (TPI)

Organisations are constantly striving to drive down costs while maintaining the quality of their products and services. In recent years, much has been written in both the academic and practitioner literature on the application of Lean principles for the elimination of waste and focusing of energies on value-creating activities.

Novel methodologies for determining the mineral content of complex multivitamin tablets

5 September 2014 | By Ryan Gosselin & Nicolas Abatzoglou, Pfizer Industrial Research Chair, University of Sherbrooke / Philip Quinn, Pfizer Industrial Research Chair, University of Sherbrooke and Process Analytical Sciences Group, Pfizer Canada / Joanny Salvas & Jean-Sébastien Simard, Process Analytical Sciences Group, Pfizer Canada

Pharmaceutical product manufacturing is a conservative environment because of the obligations to abide by rigorous operation protocols aimed at insuring the highest possible product quality. A relatively recent initiativeguidance, from the U.S. FDA (Food and Drug Administration) has encouraged innovation and development of PATs (Process Analytical Technologies) for improved process…