The International Society for Pharmaceutical Engineering (ISPE) has released Parts 1 and 2 of a new series of good practice guides (GPGs) as part of its product quality lifecycle implementation (PQLI) initiative. These guides are part 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 (IPQ “In the News, July 14, 2011). 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.
The first in the series, an overview document, was published in October 2010. It covers the structure of the GPG series and includes sections on product realization, continual improvement and the benefits of using QbD in development.
Part 1 – “Product Realization using QbD, Concepts, and Principles” – is focused on the topics of criticality, design space, and control strategy. It covers process and product development and tech transfer to commercial manufacturing, and introduces the concept of a “continuum of criticality.”
Part 2 – “Product Realization using QbD, Illustrative Example,” uses a small molecule case study to illustrate how the concepts from Part 1 can be used to examine criticality, develop control strategies, and calculate design spaces, with a primary focus on drug product development. It also discusses extending the concepts into manufacturing.
The guides can be purchased in either electronic or hard copy format from ISPE.