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ISPE launched its Product Quality Lifecycle Implementation (PQLI) initiative in June 2007 to help industry find practical approaches to the global implementing of ICH Quality Guidelines. Through PQLI, ISPE is spearheading efforts to assist in the implementation of the ICH Quality documents, in particular, ICH Q8, Q9, and Q10, and to support the work of the ICH Implementation Working Group (IWG). Key goals of PQLI include the provision of a technical framework comprising, for example, explanatory documents and illustrative examples, supporting the implementation of enhanced science and risk-based approaches to product realization, technology transfer, commercial manufacture, and its continual improvement in both research- and generic-based organizations.
PQLI encompasses the whole of the product lifecycle and comprises three strategic themes:
a) Principles of Quality by Design (QbD)
b) Pharmaceutical Quality System elements
c) Enablers (knowledge management, quality risk management)
These strategic themes represent the key components of the ICH quality vision described at the July 2003 meeting in Brussels which supported the development of the ICH Quality Guidelines. Within PQLI, ISPE has established multi-disciplinary, multi-national teams in support of these strategic themes, addressing them from the perspectives of both small molecule (chemically derived) and biotechnology.
PQLI will continue its efforts to assist in the adoption and implementation of the ICH Quality vision to “Develop a harmonized pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science”.
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