pharma

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So…you’re the new QA person?

New heads of Quality Assurance come into pharmaceutical companies all the time for various reasons. If you are the new head honcho of quality, hopefully you were able to get some sense for the reasons for the vacancy during the interview process. I recognize that this is not always easy in an interview situation. I have heard such explanations as: [...]

Analysis of the Claris Warning Letter

The Warning Letter to Claris Lifesciences was one that went on and on, page after page citing violations of fundamental, block-and-tackling practices. This was surprising and a disappointment given that Claris is one of the largest sterile injectable pharmaceutical companies in India with a market presence in 76 countries worldwide.  From a patient’s perspective, their products are injected directly into [...]