ENHANCING PROCESS ANALYTICS:ANTICIPATING REGULATION?

摘要

In 2004,the U.S.Food and Drug Administration (FDA;Washington,D.C.) issued "PAT-A Framework lor Innovative Pharmaceutical Manufacture and Quality Assurance" (www.fda.gov/cder/OPS/PAT.htm).There,the desired state of pharmaceutical manufacturing and regulation is characterized by scientific understanding of how the process factors affect product quality and performance.