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QA/QC

 

article

Novel methodologies for determining the mineral content of complex multivitamin tablets

5 September 2014 | By 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

Pharmaceutical product manufacturing is a conservative environment because of the obligations to abide by rigorous operation protocols aimed at insuring the highest possible product quality. A relatively recent initiativeguidance, from the U.S. FDA (Food and Drug Administration) has encouraged innovation and development of PATs (Process Analytical Technologies) for improved process…

David Elder
David Elder
article

What does quality mean to you?

3 July 2014 | By

An effective quality risk management (QRM) process ensures proactive identification and control of potential issues that may arise during development and commercialisation. Where quality is defined as the degree to which a set of intrinsic properties of a drug product, its underpinning manufacturing process, and any supporting processes fulfils the…

Francisca Gouveia, 4Tune Engineering Ltd
Francisca Gouveia, 4Tune Engineering Ltd
article

Pharma development and manufacturing with QbD 2.0

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

Pharma and BioPharma industries are aware of the impact of production processes on sustainability of business operations. To improve performance, companies have recognised that it is necessary to better understand the drivers of both costs and revenues and the actions that can be put in place to address them.

Pills in Wrapper
Pills in Wrapper
article

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

15 April 2014 | By 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.

This article reviews some emerging applications of Process Analytical Technologies (PAT) for packaging quality testing. Specifically, four commercially-available packaging applications are explored in further detail: Raman spectroscopy for rapid material identification testing of polymeric packaging materials; vision-based elastic deformation for non-destructive blister integrity testing; X-ray monitoring for inline blister fill…

Data acquisition
Data acquisition
news

B&W Tek announces agreement with LabWare for automation and reporting

3 March 2014 | By

B&W Tek, Inc., an advanced instrumentation company that delivers lab quality Raman spectroscopy solutions through user-friendly mobile platforms, is pleased to announce its newest strategic partnership with LabWare, Inc., the global leader of Laboratory Information Management Systems (LIMS) and instrument integration software products.