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Focus on Pharma Episode 8: Pharmaceutical QbD: An Industry Progress Report Led By Ali Afnan
PharmaManufacturing.com
Faster drug approvals, real-time release, regulatory relief. These, and many other benefits, are promised by adopting Pharmaceutical Quality by Design principles. So why aren't more people embracing the concept? Skeptics continue to see QbD efforts as too expensive, time consuming and impractical, while QbD and PAT projects are being launched separately, rather than together as intended. Exploring the reasons for this apparent disconnect, and potential solutions, are Ali Afnan, Pedro Hernandez-Abad, Sam Venugopal and Gawayne Mahboubian-Jones.

Drugs in Wastewater: A Call for More Research, More Responsibility
Manufacturers must practice a heightened sense of "Pharmecovigilance" regarding drug compounds leaving their facilities as waste, says a leading expert.

Time and Cost Identified as Key Roadblocks to PAT and QbD; Experts Disagree
Results suggest that concerns about time and cost are dampening pharma's enthusiasm for PAT and QbD: Experts examined these issues in a July webcast.

Podcast: API Pollution: Are Drug Manufacturers Trying to Stymie Studies?
PharmaManufacturing.com
A recent U.S. Geological Survey study found two drug facilities in New York state releasing high levels of API into local groundwater. The manufacturers have been less than cooperative, says study lead Patrick Phillips, speaking with Senior Editor Paul Thomas. Without adequate studies, Phillips adds, there's no way of knowing what the impact of the compounds on local biota might be.

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White Papers: In Depth Research

Joining Forces: Bringing Pharma Supply Chain Management and Supply Quality Management Together
Posted: 08/03/2010
For years, drug manufacturers have been caught between two opposing forces – supply chain management and supply quality management. The only way to confront these challenges is to create a “culture of quality” that begins at the top and permeates down through the supply chain. This paper looks at how it can be done.

The New Approach to Track and Trace
Author: Cognex Corp.
Posted: 06/14/2010
A new leaner, more cost-effective approach to track and trace demands new technology. Due to advances in the power of digital signal processors (DSP), imaging sensors and decoding algorithms, traceability applications such as ID code reading, text verification, mark quality assessment, and label inspection can now be accomplished more economically using the latest generation of smart camera vision systems.

Risk Mismanagement: Where Pharma Companies Err
Author: KPMG
Posted: 02/23/2010
In a survey of 65 life sciences execs, the Economist Intelligence Unit and KPMG found that risk management priorities are misguided. Companies fail to focus on embracing risk processes throughout their organizations, and most emphasize activities aimed at controlling regulatory risk rather than anticipating potentially greater threats.

A Quality by Design Approach to Developing and Validating Dissolution Test Methods
Author: GSK
Posted: 02/19/2010
GSK scientist Alger Salt describes how to apply QbD principles to developing and validating dissolution testing.

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