Author Archives: mmummudi

Process metrics or PMs, are characteristics of a pharmaceutical process that are critical to ensuring product quality and process performance. They are characteristics of the processing ‘micro-environment’ for a given unit operations equipment or ‘process asset’. Generally speaking, maintaining these CPMs at the same (or nearly same) values across scales is a necessary condition forContinue reading “Process Metrics – The Keystone Of Process Understanding”

Asset characterization is an important step in determining the process performance capability of a given unit operations equipment. As we saw in an earlier post, it forms the backbone of process understanding and science-driven development/transfer. Lets recap things a bit here: asset characterization can be performed conveniently using computational/first-principles models. this results in a digitalContinue reading “Asset Characterization : Digital Nameplating Of Assets”

Process signatures capture the scale-independent relationships for a given unit operation or unit process. They represent scale-up or transfer rules that can be used to seamlessly move processes from one equipment to another, from site to another etc. Process signatures are based on the tenet that achieving process similarity is the same as achieving similarityContinue reading “Process Signatures : How You Can Stop Worrying and Start Loving Scale-up”

Pharma processes are among the more complex processes in the chemical industry. Over the past decade or so, the traditional “quality-by-testing” approach of trial-and-error is being consciously replaced, partly or fully, by a more scientific approach across all aspects of pharmaceutical engineering – discovery, development and manufacturing. This “Quality by Design (QbD)” paradigm – whichContinue reading “Fundamental Understanding In Pharma Processes”