ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative has been one of the leading efforts to translate ICH guidance on science- and risk-based manufacturing into more practical language and to outline how Q8, Q9, and Q10 might be applied by industry.
Yesterday marked a significant milestone for PQLI, as ISPE released the first good practice guide to come from the initiative, an “Overview of Product Design, Development, and Realization: A Science- and Risk-Based Approach to Implementation“. The release has been years in the making, and congratulations are in order to David Selby, John Berridge, Chris Potter and the many other members of the volunteer working group that saw it through to completion. (Successive guides in the series will be released next year.)
The document is free for ISPE members, and just $25 for nonmembers. The text of ISPE’s news release follows here:
TAMPA, FLORIDA, USA, 20 October 2010 – ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, 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.
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 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.
The objective of this series of Guides is to provide a range of how to tools for practitioners developing products and their manufacturing processes using the enhanced, Quality by Design (QbD) approach described in ICH guideline, Q8 (R2). The Guides aim to give more insight than is given in the ICH Guidelines, and include more explanation and examples of individual topics. This series is intended to assist industry in the development and implementation of pragmatic and practical how-to approaches to product realization using the QbD approach supported by sound scientific, engineering, and business principles.
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