FDA工艺分析技术.pdf

Can Pharmaceutical Industry Ignore PAT? Matt Safi Eurotherm Life Science group October 2005 Agenda • What is wrong with Pharmaceutical Manufacturing today • Is PAT the solution? • Can Pharmaceutical industry ignore PAT? Pharmaceutical Manufacturing Today What is Wrong today? • Pressure on prices • Low utilization 30 - 40 % on average • Excessive amounts of product non-conformances • Long lead-times due to stage and final product testing • Capital and labor intensive • High operating costs • High inventories and excessive warehouse capacity Typical Pharmaceutical Process life Cycle 20 Days Final Film Blend Coating Granulation Step Raw Chemical Processing Blend 1 Compress Packaging Material weighing QC1 QC2 QC3 •Particle Size •Description •API •Load •ID 10 Days •Assay 15 Days •Impurity •Dissolution W hat is wrong today? • Most processes are fixed with variable materials, resulting in variable quality of product. • Most processes are not well understood. • Existing procedural approach has created a “climate of fear” stifling innovation .