GMP Tips

Genzyme received a draft consent decree from the FDA regarding its Allston manufacturing plant. The draft provides for an up-front disgorgement of past profits of $175 million. GMP Tip Prevention is ALWAYS less costly than correction. Make sure you have an EFFECTIVE Corrective and Preventive Action system in place. Don’t take the path that Genzyme [...]

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FDA has issued Apotex with another warning letter about cGMP violations at two plants explaining the firm’s response to previous warnings “is inadequate and lacks sufficient corrective actions.” GMP Tip Read the 8-page Warning Letter issued to Apotex Inc. Preparing adequate responses to FDA 483 reports and Warning Letters is critical.  One of our recent [...]

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The looming Consent Decree for Genzyme comes after fourteen years of trouble with FDA. Read an interesting article citing Genzyme’s CEO’s “zero tolerance for screwups.” Go to: www.gmptrainingsystems.com/resources Click on Timely Resource Documents GMP Tip Avoid the woes at Genzyme. Go to www.gmptrainingsystems.com/resources and click on Articles authored by David Markovitz. Download his article – [...]

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The FDA is preparing to fine the biotechnology giant Genzyme for recent manufacturing problems and take a greater role in overseeing operations at the company’s factory in Boston. Genzyme just announced that FDA’s action would probably result in a Consent Decree. Genzyme’s announcement indicates that federal regulators have, in effect, lost confidence in the company’s [...]

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