Maximize your efforts in QbD and PAT implementation using Chemometrics
The Food and Drug Administration (FDA) launched in 2004 the PAT initiative (Process Analytical Technology) to improve the design, supervision and process control in the pharmaceutical industry.
The quality of manufactured products is not only controlled as the end-product testing (QC – Quality Control), but also during the process (QbD – Quality by Design), to achieve Real-Time Release (RTR).
Within this PAT approach, the Design of Experiments (DoE) and other chemometric tools play an important role.
Chemometric tools are crucial within the PAT and QbD approaches to:
OPTIMIZE the development and the validation of products and processes
MONITOR continuous or batch processes
DEVELOP methods for fast at-line or on-line product characterization
IMPLEMENT quality control of incoming raw materials and in-process products
TEST end-products vs standard quality
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