(401d) Making PAT an Integral and Sustained Part of Manufacturing Operations

Authors: 
O'Reilly, J., Roche


To be further developed.

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Modern process analytical technology (PAT) can promise many innovative solutions in the manufacture of API.  However, to implement such technologies in a sustainable way is often the greatest challenge.

This talk looks at some of the current PAT projects at Roche Clarecastle and in particular the innovative strategy we are developing to make PAT an integral and sustained part of our manufacturing operations.  

The concepts of in-process data samples (IPDS) and PAT-QC are introduced. The use of PAT as a continuous real-time process verification/validation tool is also discussed with reference to the latest FDA process validation guideline.

The concepts of in-process data samples (IPDS) and PAT-QC are introduced. The use of PAT as a continuous real-time process verification/validation tool is also discussed with reference to the latest FDA process validation guideline.

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