How to Right-Size Quality and CGMP Compliance Investments

December 11, 2018 Becky Hurt

In the rush to submit a marketing application for a new product – to meet a deadline, please investors or beat a competitor to market – most companies reasonably focus on their clinical data package. That’s understandable: approval always will hinge on safety and efficacy. But companies that don’t prepare adequately for facility inspections and Current Good Manufacturing Practice (CGMP) compliance until late in their process often learn a hard lesson: submissions can falter on facilities issues alone (i.e., quality or compliance issues observed during an inspection) even when their clinical and Chemistry, Manufacturing, and Controls (CMC) dossiers are excellent. This article looks at best practice approaches to right-size product quality and GCMP investments of your product. Click to read more:

 

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