Articles
RSSPQLI®: Current Status And Future Plans
May 1, 2009
•White Paper: PQLI®: Current Status And Future Plans
By John C. Berridge
The International Society for Pharmaceutical Engineering (ISPE) launched its Product Quality Lifecycle Implementation (PQLI®) initiative in June 2007 to help industry find practical approaches to the global implementation of recent ICH guidelines. Through PQLI, ISPE is spearheading approaches to assist in the implementation of, in particular, ICH Q8(R1) (Pharmaceutical Development), Q9 (Quality Risk Assessment), and Q10 (Pharmaceutical Quality Systems). Key goals of PQLI include the provision of a technical framework required for the implementation of Quality by Design (QbD) in development and manufacturing environments.
PQLI started with highly interactive sessions in Europe and the USA aimed at gathering the views of both regulators and industry on key topics that needed the development of practical guidance to underwrite their successful implementation. It very quickly became clear that despite further elaboration in the revision to ICH Q8, there was an urgent need for examples and case studies that would assist in the understanding of three key concepts. These concepts were design space, control strategy, and how to designate critical quality attributes and critical process parameters.
Click Here To Download:•White Paper: PQLI®: Current Status And Future Plans
