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2022 ISPE Annual Meeting & Expo

SES212b - The Control Strategy Maturity Model

Nov 1, 2022 4:00pm ‐ Nov 1, 2022 5:30pm


Many illustrations and maturity models are available that describes different aspects of Control Strategy maturity and digitalization maturity. The pharmaceutical industry is undergoing a digital transformation which is one necessary prerequisite to achieving higher levels of Control Strategy maturity. The ISPE PAT&LCS Control Strategy maturity model attempts to translate and harmonize terms and define the key capabilities to achieve advanced manufacturing Control Strategies. The model can be used in many ways. One is as a self-assess tool where the current level of the manufacturing Control Strategy is assessed for a given product or site; and gaps and actions proposed that are required to achieve the desired state for product manufacture and release; or to support any further investment in platforms or technologies, just to mention a few.


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