Industry guidances and drafts by organizations like FDA, ICH, EMEA, USP & IPEC. Harmonization. Government policy. Validation, inspection, CGMP, imports & safety. Quality by Design (QbD), process analytical technology.
 | January 2, 2012
By:Barbara Scott
Pharmaceutical Technology
The author describes how providing appropriate information about the API in the Common Technical Document can aid FDA's review of an abbreviated new drug application.
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December 21, 2011
By:Erik Greb
Equipment and Processing Report
Risk assessment is not a new concept to the pharmaceutical industry, but lately the phrase has become a mantra. A systemic, science-based way to manage risk is becoming essential to meeting the spirit and letter of FDA requirements.
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 | December 2, 2011
Pharmaceutical Technology
A Q&A with Deborah Tanner, executive vice-president and group president of R&D laboratories at Covance, on recent industry trends.
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November 16, 2011
By:Erik Greb
Equipment and Processing Report
Until now, the industry has adhered to the tradition of producing three batches of product to validate its manufacturing processes. But FDA?s new process-validation guidance does not prescribe any number of batches that is necessary for compliance.
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November 2, 2011
By:Fernando Muzzio, Mauricio Futran
Pharmaceutical Technology
The authors propose a plan to keep the US pharma industry afloat and in the lead.
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November 2, 2011
By:Angie Drakulich
Pharmaceutical Technology
Novartis AG and Novartis Pharmaceuticals Corporation have been focusing research efforts on rare diseases since the company was established in 1996.
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 | November 2, 2011
By:Sean Milmo
Pharmaceutical Technology
Russia is aiming to provide an alternative to China and India for drug manufacturing, including APIs.
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