Dr. Reddy on Line Balancing and Redefining the Pharma Batch

Big Pharma may be feeling the cost pinch in manufacturing, but generic pharma feels it much, much more.  Recently, two experts at Dr. Reddy's Laboratories in India discussed the drive to smaller pharma batches and the need for better line balancing.  Note their mention of PAT.  For more, read on.   Manufacturing should be more closely tied to supply chain management, demand forecasting and R&D than ever before.  (Stay tuned for AMR's Hussein Mooraj's series of articles on this topic, beginning in January). ...all of which makes the recent AstraZeneca quote (or misquote) about manufacturing not being a strategic priority  seem quite out of place. Quality by Design is focused on product development, but feeds back into manufacturing, transforming it.  Whether manufacturing takes place within or outside the company, the function is critical and not just something that can be cut off from everything else and carried out, as cheaply as possible, by the Oompa Loompas. We hear that this year's IFPAC Conference on PAT will have the tagline "Excellence in Pharmaceutical Manufacturing."  Guess some people get it, while others still don't. IFPAC will also be expanding beyond the U.S. and Puerto Rico, into Europe, and plans a conference on the continent next year. -AMS
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  • <p>We all have to remember that Pharmaceutical consist of API and its formulation. Formulation has been examined, addressed, microscoped and studied time and time. Poor orphan is API which is the main character of the medicine that cures the disease. Poor orphan needs help, cajoling care and TLC but who cares. We need to recognize this and fix the processes that are used to produce API.</p> <p>Pardon my pun, but that is life.</p>

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