In August 2002, the FDA Agency announced a new initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century, to modernize the regulation of pharmaceutical manufacturing. The initiative is focused on risk-based approaches of pharmaceutical products quality assurance. In the area of manufacturing the progress means implementation of innovative Process Analytical Technology (PAT). The PAT considers identi- cation of critical process parameters, control of the parameters by applying novel process analyzers and steering them to form drug product of desired quality. The goal can be achieved by using scienti- c tools for design of experiments, quality of semi-product and drug product testing, continuous improvement and knowledge management.
Keywords: PAT, Process Analytical Technology, critical process parameters, risk analysis.