Tag Archive | "risk management"

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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Making Multi-Product Facilities Safe: Why Risk-MaPP Matters


By Paul Thomas, Senior Editor

Within the next few months, ISPE will release a Baseline Guide for Risk-MaPP, or the Risk-based Manufacture of Pharmaceutical Products. Based on ICH Q9, Risk-MaPP aims to provide manufacturers with a template for managing the risk of product cross-contamination within facilities. (More details can be found on the ISPE website.)

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Baking Cookies: A Recipe for QbD Success?


Dr. Andrew Walsh’s “Contemporary Concepts in Pharmaceutical Validation” class at New Jersey’s Stevens Institute of Technology strives to teach the precepts of Quality by Design (from statistics to risk management) to graduate students prepping themselves for careers in the drug industry, even though many of those practices might not be commonly used within the industry . . . yet.

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Tufts: R&D Teams Must Transform Themselves, Engage Partners


The Tufts Center for the Study of Drug Development has made available to everyone its Outlook 2010 report. (The report was first released to subscribers several months ago.) The Tufts report is one of the definitive measures of where we are in our development activities, where we’re heading, and what hoops we have to jump through to get there.

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You Just Need a Spreadsheet: Dispelling the Myths of FMEA


Toronto’s Dyadem provides Quality Risk Management (QRM) solutions and helps biotech and pharma companies establish a foundation for an ICH Q10 Pharmaceutical Quality System. We recently spoke with CEO Kevin North about a critical aspect of risk management, FMEA.

PQbD: What is FMEA’s role in a Quality by Design context? What function does it perform?

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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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