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September 02, 2011
Smartphones could become the product-authentication tool of choice. Contains online bonus material.
August 17, 2011
Using information technology tools to enhance process understanding helps reduce variability that can affect speed to market.
August 02, 2011
This study demonstrates the beneficial use of a spatial-filter velocimetry particle-size analyzer during granulation.
August 01, 2011
Manufacturers are facing ever-increasing competition while end users are expecting better value and efficacy. The authors discuss these challenges and offer practical solutions.
Companies know they need regulatory information management, but they don't always know where to start and how to weave this capability across diverse technology applications.
June 30, 2011
President Obama unveiled an Advanced Manufacturing Partnership designed to reinvigorate the country's manufacturing sector.
June 23, 2011
The Association of the British Pharmaceutical Industry (ABPI) has published a guidance that suggests best practices for managing adverse events and other pharmacovigilance data from the internet and social media tools.
June 02, 2011
FDA added a searchable database of inspection data to its website. The database lists the names and addresses of facilities that the agency inspected during fiscal years 2009 and 2010.
June 01, 2011
In January 2011, a new version of Annex 11 was released by the European Commission along with a revision of Chapter 4 of its GMP on documentation to reflect the actualities of electronic record keeping, all of which come into full effect in June 2011.
In January 2011, the European Medicines Agency (EMA) announced the new revision of EudraLex Volume 4 (GMP) - Annex 11 'Computerised Systems', and the consequential amendment of EudraLex Volume 4 - Chapter 4 ?Documentation?.