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 Lifecycle Implementation (PQLI) initiative. Written by experts representing the global pharmaceutical industry, these papers present preliminary practical scientific and technological approaches to implementing 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 is available free of charge on Springer's electronic information platform SpringerLink at http://www.springerlink.com/content/1939-8042.
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. With the publication of these articles, the ISPE PQLI Task Teams are seeking additional feedback prior to developing their respective positions into technical documents.
PQLI, a five-year initiative, has started with interactive fact-gathering sessions held in the US and Europe. Working groups will continue to collect and process information for distribution as white papers and articles to be published in JPI and Pharmaceutical Engineering Magazine. This in turn will lead to detailed technical documents and training programmes that will be produced by ISPE for the industry worldwide.
JPI is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasising innovative research and applied technologies within the pharmaceutical and biotechnology industries. It seeks to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation.
