Recommended

New webinar: The path to optimisation in pharmaceutical microbiology
New upcoming webinar: Navigating pharmaceutical environmental monitoring in a changing industry! Register your details today!
Explore our new Pharma Horizons: Sustainability report for key developments in the pharmaceutical industry!
Discover more in our new application note: validating recombinant cascade reagents in 3 simple steps

List view / Grid view

Product Quality Lifecycle Implementation (PQLI)

 

Pills and tablets
Pills and tablets
article

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…

Purple pills, tablets
Purple pills, tablets
article

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…

Figure 2: PQLI Criticality Decision Tree to Delineate Categories and Levels of Criticality Across the Product Lifecycle (NOR = Normal Operating Range PAR = Proven Acceptable Range CpK = Measure of process robustness PAT = Process Analytical Technology)
Figure 2: PQLI Criticality Decision Tree to Delineate Categories and Levels of Criticality Across the Product Lifecycle (NOR = Normal Operating Range PAR = Proven Acceptable Range CpK = Measure of process robustness PAT = Process Analytical Technology)
article

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…