Tag Archive | "pharmacutical quality"

Profitability, Integrity and the Cost of Poor Pharma Quality


By Bikash Chatterjee, President and CTO, Pharmatech Associates

As major blockbuster drugs come off patent, the scramble among generics to capture these new markets is just beginning. We can expect the U.S. market to experience continued change and consolidation with cost cutting remaining at the top of the priority list for big pharma. We can also expect emerging market drug powerhouses to try and gain market share as these blockbusters come off patent. Pressure to be competitive in these new market opportunities is creating a sort of perfect storm.

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8 Rules for Moving Drug Manufacturing Forward


A fast-changing environment and slow-changing species can only lead to one thing—extinction, says Claus Weisemann, VP Quality & Regulatory Compliance for Grifols Biologicals. Weisemann should know, having seen the drug industry from myriad positions and companies over a long career. As such, he has developed a set of rules for moving manufacturing forward, from production to quality testing, and presents them in the video below with humor and passion. The video was filmed September 27, 2010, at the Emerson Global Users Exchange in San Antonio.

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Sage Quality Management Advice? Only the Shadow Knows


A new blog started up this summer devoted to issues of pharma Quality Assurance, with a slant toward current, progressive practices as espoused in ICH Q10 and other documents. The QA Pharm, which posts every week or so, is a welcome voice in the ongoing discussions of what constitute best practices in pharmaceutical Quality.

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Ali Afnan: Defining Pharmaceutical Quality


By Ali Afnan, Contributing Editor

From the start, human beings have sought quality in all aspects of their lives. Quality is a universal concept, tangible and simple, but its definition is usually subjective.

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New Patterns for Quality


By Alison Smith and Hussain Mooraj, AMR Research

Sweeping changes instituted by FDA in recent years are beginning to have a tangible impact on the way pharmaceutical manufacturers conduct business. This time, though, it isn’t a compliance fire drill focused on electronic signature capture or electronic application delivery formats. Instead, it goes much deeper, transforming the way life sciences companies look at their research, development and manufacturing process engineering organizations.

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