(ISPE: Tampa, Florida) -- The June 2008 issue of the Journal of Pharmaceutical Innovation (JPI) is publishing the first scientific papers outlining the progress made on the International Society for Pharmaceutical Engineering’s (ISPE) product quality life cycle implementation (PQLI) initiative. Written by experts representing the global pharmaceutical manufacturing industry, the papers present preliminary practical scientific and technological approaches to implementing International Conference on Harmonization (ICH) documents that address Pharmaceutical Development (Q8 and Q8[R]), Quality Risk Management (Q9), and Pharmaceutical Quality Systems (Q10). The June issue will be published in print and with open access on SpringerLink with the possibility to comment.

The PQLI initiative was launched by 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.

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