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Tuesday, March 15, 2011

Johnson & Johnson Consent Decree: A lesson in Drug cGMPs

The folks at Pharmalot have written an article about the Johnson & Johnson consent decree (  The article includes a link to the consent itself, which details the cGMP requirements FDA expects to see at the drug manufacturer's facility. 

The consent decree details the systems that need to be set up to ensure that the company's drug products are produced properly and are safe and efficacious. The document makes clear that the plant needs to build a quality system from the ground up and is evidence of the catastrophic QA failure that lead to the recalls and the consent decree itself.  

My purpose in posting this information is not to spread salacious gossip but to provide what I think is useful information.  In my view, the consent decree can be used as a checklist to review the cGMPs at your manufacturing facility.  If you are unable to download the consent decree, please leave a comment with your email address and I will send it to you. (Your email address will not be published.)

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