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Showing 6 posts of 51 posts found.

FDA slaps import ban on Claris Life Sciences

November 16, 2010
Manufacturing and Production Ahmedabad, Claris Life Sciences, FDA, GMP, GMP violations, Good Manufacturing Practice, Ranbaxy Pharmaceuticals, manufacturing compliance

Indian drugmaker Claris Life Sciences has been prohibited from importing products into the US after manufacturing quality problems emerged at …

News

6 tips for regulatory compliance in logistics

November 2, 2010
Manufacturing and Production, Research and Development Biocair, GMP, International Council for Harmonisation, pharma logistics, regulatory compliance

Regulation! Regulation! Regulation! Never has our business been more highly regulated than it is today. Seemingly, rules change every day. …

Feature

FDA warns BMS over manufacturing plant in Puerto Rico

September 15, 2010
Manufacturing and Production BMS, FDA, GMP, Puerto Rico

A plant operated by Bristol-Myers Squibb in Puerto Rico has been cited by the US Food and Drug Administration for …

News

CSL vaccine plant cited in FDA letter

July 1, 2010
Manufacturing and Production CSL, GMP, P&G, manufacturing compliance

CSL Biotherapies has been sent a letter by the US Food and Drug Administration which indicates that vials of seasonal …

News

FDA draft CMC guidance could cut down on red tape

June 30, 2010
Manufacturing and Production FDA, GMP, manufacturing

The FDA has published draft guidance aimed at alleviating the burden on pharmaceutical companies of notifying the agency of minor …

News

FDA tightens pharma’s responsibility for outsourcing

June 22, 2010
Manufacturing and Production FDA, GMP, manufacturing, outsourcing

Pharmaceutical manufacturers will be held more responsible for the activities of their suppliers and outsourcing partners under a new approach …

News
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