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Product Quality Lifecycle Implementation (PQLI)



PAT Initiative review 2008

10 January 2009 | By Martin Warman, Director, MWC Ltd

As the industry approaches the five year anniversary of the ground breaking regulator initiatives (the ‘PAT framework' and ‘cGMPs for the 21st Century'1,2), it is time to assess the impact they have had on the industry and to look forward to what the industry may look like in another five…


Successful Process Analytical Technology (PAT) implementation in pharmaceutical manufacturing

29 September 2008 | By Thirunellai G. Venkateshwaran (Senior Director, New Products Quality, Global Quality and Compliance), John Levins (Senior Director, Technology Transfer & Process Innovation) and Stephen P. Simmons (Head of New Product Quality and Quality by Design), all Wyeth Pharmaceuticals

The use of Process Analytical Technology (PAT) while a relatively new concept to the Pharmaceutical Industry has been a tried and tested concept in the petrochemical industry for many years. The adaptation of PAT systems by the Pharmaceutical Industry was accelerated by the recent initiatives of the regulatory authorities globally…


Product Quality Lifecycle Implementation (PQLI) – providing practical solutions

23 January 2008 | By

This article discusses ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative, which is to provide practical guidance for implementation of ICH Q8, Q9 and Q10. It represents the author’s individual opinion. It should be noted that PQLI is an evolving work area and so will continue to develop beyond the position…