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

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PharmTech

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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.

Biosimilars Increase the Need for IT to Reduce Variability

August 17, 2011

Equipment and Processing Report

Using information technology tools to enhance process understanding helps reduce variability that can affect speed to market.

Understanding Fluidized-Bed Granulation

August 2, 2011

Pharmaceutical Technology

This study demonstrates the beneficial use of a spatial-filter velocimetry particle-size analyzer during granulation.

Outsourced Manufacturing Operations

August 1, 2011

Pharmaceutical Technology

Manufacturers are facing ever-increasing competition while end users are expecting better value and efficacy. The authors discuss these challenges and offer practical solutions.

Managing Information Overload

August 1, 2011

Pharmaceutical Technology Europe

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.

Obama Initiates Partnership to Reinvigorate Manufacturing

June 30, 2011

ePT--the Electronic Newsletter of Pharmaceutical Technology

President Obama unveiled an Advanced Manufacturing Partnership designed to reinvigorate the country's manufacturing sector.

ABPI Releases Social Media Guidance

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.

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.

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.

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?.

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Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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