QbD is a significant tool, to produce optimized quality product, in pharmaceutical industry. It is a continuous process, of building consistent quality products. It consists of several factors such as Target product Profile (TPP), Critical quality attributes (CQA). Design space is one of the important approach, to ensure the quality product through interacting critical process parameters. It emphasizes the interactions, of various inputs in various dimensions. It further leads to, establishment of design space to perform design of experiment (DOE) which includes interactions of various input variables and is based upon prior knowledge. It is dependent upon equipment design, principal and batch size. The control space or normal operating ranges are lower and higher limits of critical raw material attribute and process parameters. The control space should be within design space. The overall approach toward process characterization involves three key steps. First, risk analysis is performed to identify parameters for process characterization. Second, studies are designed using design of experiments (DOE), such that the data are amenable for use in understanding and defining the design space. And third, the studies are executed and the results analyzed to determine the importance of the parameters as well as their role in establishing design space.
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