GMP Tips

GMP Tip The U.S. FDA announced on March 22, 2011 that Terumo Cardiovascular Systems Corporation has signed a consent decree of permanent injunction. The consent decree prohibits the company from manufacturing and distributing two heart-lung bypass systems and other cardiovascular devices to new customers and  restricts sale of these systems to existing customers until TCVS [...]

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The early bird discount for our May 4-5 Boot Camps – GMP Boot Camp in Newark, NJ and Cleaning Validation Boot Camp in Philadelphia, PA ends March 25. Register this week and save 15% on tuition. We limit attendance to 15 people to optimize the learning environment. These are hands-on workshops. GMP Tip Sharpen your [...]

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2010 was a cruel year for Johnson and Johnson. The ugliness continues. Here’s what was announced during the week of March 7th alone. J & J’s McNeil Consumer Healthcare enters a Consent Decree of Permanent Injunction for three manufacturing sites. J & J’s Animus unit recalled more than 384,000 insulin pumps cartridges. J & J’s [...]

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Unilever United States Inc. announced a recall of certain lots of Skippy Peanut Butter due to possible contamination with salmonella. What is it with manufacturing peanut butter? Is it that hard to maintain a clean facility and clean equipment? GMP Tip Cleaning and cleaning validation are paramount in the manufacture of drugs, foods, dietary supplements, [...]

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