(401d) Making PAT an Integral and Sustained Part of Manufacturing Operations
AIChE Annual Meeting
2012
2012 AIChE Annual Meeting
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Application of PAT in the Manufacturing Setting
Wednesday, October 31, 2012 - 9:45am to 10:10am
To be further developed.
A minimum of 150 words is required for the abstract text, and no more than 1500 words may be submitted. Each abstract is allowed to include up to 20 figures.
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.
See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture