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Product Quality Life-Cycle Implementation Guide

First in a how-to series to help develop and implement pragmatic approaches to product realization

Published: Monday, October 25, 2010 - 12:04

(ISPE: Tampa, FL) -- 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 nonmembers.

The guide is an introduction to and an overview of the PQLI guides series, which collectively address product and process development, and transfer to and establishment of commercial manufacturers using science- and risk-based approaches. The series uses the International Conference on Harmonization (ICH) guidelines Pharmaceutical Development Q8 (R2), Quality Risk Management Q9, and Pharmaceutical Quality Systems Q10 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 link between the high-level ICH guidelines and the needs of those wanting to implement them,” says 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 PQLI series guides are meant 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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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.