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ISPE

Quality Insider

ISPE Releases Product Quality Lifecycle Implementation Series

Two good practice guides focus on quality by design principles and practices

Published: Friday, November 11, 2011 - 12:46

(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) has released Parts 1 and 2 of a new series of good practice guides on product quality lifecycle implementation (PQLI). These 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 life cycle. 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,” says PQLI project manager John Berridge. “Quality cannot be added during the testing phase; it must be built-in by design. The PQLI guide series gives industry personnel a road map 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, focuses on the topics of criticality, design space, and control strategy. Part 1 addresses product and process development, transfer to, and establishment of commercial manufacturing using science- and risk-based approaches. It also includes an introduction to and overview of the guide sections.

The second guide, Part 2—Product Realization 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.

For more information on the ISPE guide series or to order copies in either bound or electronic format, visit the ISPE website.

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ISPE

The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association of 22,000 pharmaceutical professionals in 90 countries who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions. ISPE provides its members opportunities to develop 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 for a global audience. Its world headquarters are in Tampa, Florida, with offices in Brussels, Belgium, Shanghai, China, and Singapore.