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 [...]

FDA Enforcement Inflation: What’s Next?

I grew up in a home where just a cast of my mother’s glance was enough to cause me to stop dead in my tracks. I knew “the look” quite well.  There were no raised voices.  When a parent doesn’t follow through on the gentlest of correction, then the parent is communicating that an appropriate response is optional. Out of [...]