Tag Archive | "ICH"

WHO Posts Draft Guidelines on QRM


WHO has made public draft guidelines on Quality Risk Management (and is receiving comments until October 1). The draft represents a departure from the hazard analysis and critical control point (HACCP) methodology previously espoused by the organization, in favor of risk management principles outlined by ICH and FDA.

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A QbD Summer Reading List


Whether you’re bound for the beach, the mountains, or the office, why not take along some summer reading? We’ve compiled a list of some of the more noteworthy QbD-related articles and items to be published this summer from various sources. Upload them to your laptop, or print them and put them in your suitcase. And let us know if you have QbD reading suggestions as well.

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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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Winning the Space Race


By Jason Kamm, Tunnell Consulting, Inc.

ICH (the International Conference on Harmonization, www.ich.org) Q8 and the Quality by Design (QbD) guidance issued by the FDA offer pharmaceutical manufacturers a significant opportunity to design quality into their manufacturing processes instead of inspecting it in after the fact. Companies that take advantage of Q8 report seeing fewer deviations and rejected batches, reducing risk and easing regulatory compliance burdens, while achieving continuous improvement. The key to achieving QbD is to successively map and master three “spaces”:

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Is QbD Still Lost in Translation?


By Paul Thomas, Senior Editor

Quality by Design is at a bit of a sticking point, with guidance documents firmly in place—namely, ICH Q8, Q9, and Q10—but not enough comprehensive (and public) examples of how to implement them. The case studies that have been published are informative but still anecdotal and not always directly relevant to different drugs and different processes.

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