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Implementing New Process Analytic Technologies: The underlying challenges PAT Subcommittee, June 12-13, 2002 Outline Background information sources Perceived benefits of PAT implementation What are the underlying challenges? What can manufacturers do? What can vendors do? What can the FDA do? Background Information Sources ~15 Yrs in Process Development Mfg. Trained in Biochemistry Microbiology Worked in three Biotech/Pharma companies Intimate with data problems in PD and manufacturing ~5 Yrs with Aegis Analytical Corporation Venture funded by GlaxoSmithKline, Merck, Aventis Invited presentations to ~30 top Pharma Biotech Customer advisory panel requirements consortia Benefits of PAT Implementation Greater control of product uniformity Improved safety, quality compliance Shorter cycle times, batch release times Cost savings, supply chain stability Moves us towards parametric release Cost savings, lower inventory Moves us towards continuous operations Improved control, significant capital adjustment What about today’s failure rates, compliance yield problems? The Quality Compliance Challenge US Drug products are of high quality BUT: Increasing trend towards manufacturing problems Recalls, disruption of operations, drug shortages Negative impact on New Drug Applications (NDA) Low efficiency manufacturing and QA Slow innovation and modernization Why do these problems occur? Janet Woodcock, M.D. FDA Science Board Presentation November 16. 2001 Data-intensive Decision-making Identify and control Critical Process Parameters Quality regulatory compliance (GMP): Parameter review for batch release Setting defensible specifications Investigation of atypical batches Manufacturing process validation Production trend analysis Annual Product Reviews (APRs) Process control (stability): Shorten process start-up/scale-up times Shorten trouble-shooting time/adverse trend reversal Improve process stability, productivity quality Impro