IT: The application of information technology in process development and pharmaceutical manufacturing - Pharmaceutical Technology

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PharmTech Europe

IT
Mobile technology, wireless monitoring systems, RFID. LIMS and electronic notebook systems. Automation, QBAS, & process analytical technology. Service-oriented architecture & integration. Risk management and CAPA.

FDA Unveils Inspections Database

June 2, 2011

ePT--the Electronic Newsletter of Pharmaceutical Technology

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.

New Annex 11: Enabling Innovation

June 1, 2011

Pharmaceutical Technology Europe

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?.

Annex 11: Progress in EU Computer Systems Guidelines

June 1, 2011

Pharmaceutical Technology Europe

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.

IBM Reboots Drug Discover

May 2, 2011

Pharmaceutical Technology

Can the semiconductor industry help Big Pharma develop therapies?

Methods for the Automated Manufacturing of an Autologous Dendritic-Cell Immunotherapy

May 1, 2011

Pharmaceutical Technology

The authors developed automated equipment that uses functionally closed disposables to perform cellular and ribonucleic processing.

Week of Apr. 21, 2011: Company Notes: Axcan acquires Mpex Pharmaceuticals; Bend Research receives patent for improving bioavailability of low-solubility drugs; and More.

April 21, 2011
ePT--the Electronic Newsletter of Pharmaceutical Technology

Axcan acquires Mpex Pharmaceuticals; Bend Research receives patent for improving bioavailability of low-solubility drugs; and More.

Technology Transfer in Global Health Initiatives

April 6, 2011

PTSM: Pharmaceutical Technology Sourcing and Management

Eli Lilly and GlaxoSmithKline are among several pharmaceutical companies using technology transfer as way to improve health outcomes in the developing world.

Week of Feb. 28, 2011: Company and People Notes: Pfizer Completes King Acquisition; ViiV Healthcare Names Chairman; and More.

March 3, 2011
ePT--the Electronic Newsletter of Pharmaceutical Technology

Pfizer Completes King Acquisition; ViiV Healthcare Names Chairman; and More.

FDA Sends sanofi aventis Two Warning Letters

March 3, 2011

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA recently sent sanofi-aventis two Warning Letters for its facilities in Frankfurt am Main, Germany, and Bridgewater, NJ.

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