(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.
ADVERTISEMENT |
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.
…
Add new comment