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Reshaping pharmaceutical quality
Date:6/2/2008

The first scientific papers outlining the progress made on the Product Quality Lifecycle Implementation (PQLI) initiative are being published in the June 2008 issue of the Journal of Pharmaceutical Innovation (JPI). Written by experts representing the global pharmaceutical manufacturing industry, these papers present practical scientific and technological approaches to implementing ICH* documents that address pharmaceutical development, quality risk management and pharmaceutical quality systems. The June issue will be published in print and is available free of charge on Springer's electronic information platform SpringerLink at http://www.springerlink.com/content/1939-8042 with the possibility to comment.

The PQLI initiative was launched by the International Society for Pharmaceutical Engineering (ISPE) in June 2007 to help industry find practical technical solutions to the challenges of implementing guidelines put forth by the ICH. The first three task teams formed focused on criticality, design space and control strategy, and how these areas are linked; a Legacy Products Task Team has also been formed as the fourth topical area. PQLI is projected to be at least a five-year initiative that has started with interactive fact-gathering sessions held in the USA and Europe. For background information on the PQLI papers, please see http://springer.com/12247.

The criticality study describes a mechanism for categorizing and delineating criticality for quality attributes, variables, material attributes and process parameters in accordance with a risk-based approach reflective of quality by design (QbD) principles. Design space discussions considered the linkage of the patient experience with product quality. The Control Strategy Team has proposed a model process to enable a clear logic to be used on how a control strategy differentiates between
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Contact: Joan Robinson
joan.robinson@springer.com
49-622-148-78130
Springer
Source:Eurekalert

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