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2022 ISPE Annual Meeting & Expo

SES213b - Regulatory Considerations for Continuous API Manufacture

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


Pharmaceutical Continuous manufacturing has made significant advances over the past 10 years. Most of the successes have been with solid oral dose. Continuous manufacturing of APIs has lagged to some degree due to the complexities of API synthesis. We will present the complexities and underlying activities required to utilize and implement continuous manufacturing from a regulatory perspective. Defining where the GMP process begins, control strategies, use of Process analytical technologies, and process development/validation considerations necessary for implementation. In addition, an overview of the current continuous manufacturing regulatory landscape.


  • Adam Lambert, VP, Product and Process Development, Pharmatech Associates

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