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Introduce modern manufacturing and process development tools based on designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality. Introduce students with pharmaceutical process design (including QbD), manufacturing and life cycle management, risk analysis under a GMP environment and integrated on validated quality systems. Pharmaceutical manufacturing paradigms like continuous manufacturing and real time release testing procedures. Throrough discussions on the quality guidelines and requirements when filing new product approvals request to regulatory authorities (process focus). Skills acquired previously at MST-I are fundamental.
-Process analytics: real time monitoring of pharmaceutical processes (drug synthesis and formulation)
-Process analytical technology tools: the palette and how to handle in practice
-Processing large volumes of process/product data
-Handling and processing spectroscopic data.
-The cGMP environmnent.
-The quality regulatory framework (quality guidelines). ICH quality guidelines.
-Batch processes analysis.
-Quality risk analysis for manufacturing processes development.
-Pharmaceutical development using QbD principles: obtaining design-spaces.
-Planning and running fasctorial experimental designs.
-Continuous manufacturing: basics, operation, monitoring and control.
-Real time release testing.
-Managing the life cycle of pharmaceutical products. Industry 4.0: tools and goals.