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Process Analytical Technology (PAT) & Quality by Design (QbD)

A selection of articles from European Pharmaceutical Review covering Process Analytical Technology (PAT), Quality by Design (QbD), Six Sigma, Near Infrared (NIR) and Chemometrics:

 

NIR: In-depth focus 2014

5 September 2014
José Manuel Amigo, Milad Rouhi Khorasani, Jukka Rantanen, Poul Bertelsen, Lizbeth Martinez

The flexibility of regularisation processes for multivariate calibration maintenance

5 September 2014
Dr. John H. Kalivas, Editor for the Journal of Chemometrics and Applied Spectroscopy.

Lean, Six Sigma, people and organisations

5 September 2014
Dr. Stephen McGrath, Teva Pharmaceuticals Ireland (TPI)

Novel methodologies for determining the mineral content of complex multivitamin tablets

5 September 2014
Ryan Gosselin & Nicolas Abatzoglou, Pfizer Industrial Research Chair, University of Sherbrooke / Philip Quinn, Pfizer Industrial Research Chair, University of Sherbrooke and Process Analytical Sciences Group, Pfizer Canada / Joanny Salvas & Jean-Sébastien Simard, Process Analytical Sciences Group, Pfizer Canada

Foreword: What does quality mean to you?

3 July 2014
Dave Elder, GlaxoSmithKline and JPAG

Pharma development and manufacturing with QbD 2.0

3 July 2014
José Menezes, Institute of Biotechnology and Bioenginerring, IST, Universidade de Lisboa / Francisca Gouveia and Pedro Felizardo, 4Tune Engineering Ltd

PAT for packaging: review of applications for expeditious, nondestructive quality testing

15 April 2014
Jose Montenegro-Alvarado, Bradley Diehl, Jean-Maxime Guay, Steve Hammond, Hiwot Isaac, Ben Lyons, Conor McSweeney, Seamus O’Neill, Jean-Sébastien Simard and Joep Timmermans, Pfizer Inc.

Process Analytical Technology (PAT): In-depth focus 2013

16 December 2013
Morten Allesø, Anette Seo Torstenson, Mette Bryder and Per Holm, Chemical & Pharmaceutical Research (H. Lundbeck A/S), Anneleen Burggraeve, Tom Van den Kerkhof, Jeroen Geens, Lieve Bijnens and Mario Hellings (Johnson & Johnson)

Foreword: ICH Q6A – Specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances

15 December 2013
Dave Elder, GlaxoSmithKline and JPAG

ICH Q3D: Metal Impurities: A Critical Evaluation

22 October 2013
David Elder, JPAG and GlaxoSmithKline / Andrew Teasdale, JPAG chairman and AstraZeneca

Six Sigma: How Rottapharm is using Lean Six Sigma principles

20 August 2013
Richard Hayes, Continuous Improvement Manager, Rottapharm

Chemometrics: Implementing multivariate data analysis to monitor mammalian cell culture processes

13 June 2013
Payal Roychoudhury, formerly AstraZeneca and Ronan O’Kennedy, Fujifilm Diosynth Biotechologies and Jim Faulkner, GlaxoSmithKline and Brian McNeil & Linda M. Harvey University of Strathclyde

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