FOR IMMEDIATE RELEASE
—New Good Practice Guides focus on Quality by Design principles and practices—
(TAMPA, FLORIDA, USA, 4 November 2011) – ISPE today announced that it will soon release Parts 1 and 2 of a new series of Good Practice Guides on Product Quality Lifecycle Implementation (PQLI®). These two new Guides comprise the official first and second volumes of a planned series of PQLI Guides, which collectively address product and process development through a Quality by Design approach that covers the entire product lifecycle. The series uses ICH guidelines Q8 (R2), Pharmaceutical Development, Q9, Quality Risk Management, and Q10, Pharmaceutical Quality System as a basis, together with other relevant ICH guidelines.
“In recent years, both the industry and regulators have realized the importance of designing product quality into the process itself. Quality cannot be added during the testing phase; it must be built-in by design,” said PQLI Project Manager John Berridge. “The PQLI Guide Series gives industry personnel a roadmap for how to build quality into their processes, from product conception to continual improvement after the product is brought to market.”
The first Guide in the series, Part 1 – Product Realization using QbD, Concepts, and Principles, is focused on the topics of criticality, design space, and control strategy. Part 1 addresses product and process development, transfer to, and establishment of, commercial manufacture using science- and risk-based approaches. It also includes an introduction to, and overview of, the Guide sections.
The second Guide, Part 2 – Product Realizations using QbD, Illustrative Example, presents a small molecule case study developed by the ISPE PQLI teams. The case study provides details of the application of the approaches to product and process understanding using quality risk management. Part 2 also examines many case studies in the public domain using ICH guidelines Q8 (R2), Q9, Q10, and other relevant ICH guidelines.
The two PQLI Guides will be available in print for the first time at the 2011 ISPE Annual Meeting, which will take place at the Gaylord Texan Hotel in Grapevine, Texas, USA on 6-9 November, 2011. As a part of the Guide series release, ISPE is extending a special offer to Members who register for Annual Meeting: any Member who purchases Part 1 of the Guide will receive Part 2 free of charge, which amounts to a savings of US$145.
For more information on the ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement, Parts 1 and 2, or to order copies in either bound or electronic form, visit www.ISPE.org/PQLI-Guides/Product-Realization-QbD-Concepts.
ISPE, the International Society for Pharmaceutical Engineering, is a not-for-profit Society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions. ISPE is “Connecting a World of Pharmaceutical Knowledge” by providing Members with opportunities to develop their technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.