ISPE Releases Good Practice Guide
ISPE has released a new Good Practice Guide (GPG), titled Product Quality Lifecycle Implementation (PQLI) Guide: Overview of Product Design, Development, and Realization: A Science- and Risk-Based Approach to Implementation. This Guide, which is the first in a series of ISPE PQLI Good Practice Guides, is being offered online as a free download for ISPE Members, and at a cost of $25 for non-Members.
According to an ISPE announcement, the guide is an introduction to and an overview of the PQLI Guides Series, which collectively address product and process development, transfer to, and establishment of, commercial manufacture using science- and risk-based approaches. 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 PQLI initiative and Good Practice Guide series are the result of several years’ work by an international team of dedicated volunteers.
“ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative <http://www.ispe.org/cs/explore_by_topic/pqli_resources> provides the linkage between the high-level ICH guidelines and the needs of those wanting to implement them,” said PQLI Project Manager John Berridge. “This program is critically important in order to share the latest developments from those directly involved in ICH and contribute to clarifying the issues and opportunities of implementation.”
The subsequent Guides in the PQLI series are tentatively scheduled for release in summer 2011, and will cover topics such as critical quality attributes and critical process parameters, design space, control strategy, and an illustrative example using a small molecule case study.