CPV Shines New Light on Old Manufacturing Processes
This article was originally published in The Gold Sheet
Biopharmaceutical manufacturers say that implementation of continued process verification has helped to update “archaic” manufacturing processes for legacy products and uncover problems with raw materials. They have reaped some business benefits as well.
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Most pharmaceutical manufacturers are adopting or making plans to adopt the continued process verification approach outlined in FDA’s November 2011 process validation guidance, which will shine a light on their manufacturing processes. But not everyone is anxious to see what that light will reveal.
The pharmaceutical industry is advancing ideas for estimating the number of batches to run during process validation as well as how to establish robust monitoring and testing programs for products on the market. Industry has been hammering out these details in the absence of many specifics in the FDA’s 2011 process validation guidance on these areas.
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