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Introduction The intent of this cGMP article is to stimulate more conversation and catalyze more improvement across our industry relating to the repeat problems we have seen for literally decades....

Q: My company is preparing to transfer in a new product to one of our manufacturing facilities. Previous technology transfer pharmaceutical projects have not always gone smoothly for us. How...

Q. I work for a contract manufacturer, and I think we have robust CAPA systems. Sometimes we close our CAPAs before we have completed our effectiveness check due to the...

Q: I am in charge of the internal audit program at my company and am wondering if you have any suggestions on how I can make this activity more valuable...

Everything you do in pharma manufacturing catches up to you eventually. And just like the state of your complexion, pharmaceutical equipment loses its pep over time and cracks around the...

Q. I have just been promoted to be in charge of investigations for my company. Our standard operating procedure (SOP) requires us to complete an FDA investigation in 30 days....