| 摘要 |
<p><P>PROBLEM TO BE SOLVED: To achieve highly-reliable quality maintenance of pharmaceuticals. <P>SOLUTION: A pharmaceutical manufacturing control device executes steps of: acquiring measurement data from a measurement instrument capable of performing non-destructive and real-time measurement of a state of a pharmaceutical placed in a manufacturing process; estimating intermediate-product critical quality attributes(particle size, moisture value, flake density, hardness, content, etc.) of the pharmaceutical by applying a preset calibration curve model to the acquired data; and applying feedback control to a controlled variable so that the estimated intermediate-product critical quality attributes conform with each target value or target-value orbit which is preset so as to stably obtain critical quality attributes (elution, formulation uniformity, content, related substance, etc.) of pharmaceuticals. <P>COPYRIGHT: (C)2013,JPO&INPIT</p> |
