Scientific papers
The current definition of the pilot scale batch size for solid oral dosage forms, set by major regulatory agencies as one-tenth of full production or 100,000 units, whichever is larger, lacks a scientific and risk assessment foundation. This criterion is arbitrary and fails to account for geometric, kinematic, and dynamic changes inherent in the scale-up process. Even meeting this criterion does not guarantee the absence of scale-up impacts on critical quality attributes, and reproducibility cannot be assured solely by limiting the scale-up size. Aligning with the 21st Century Good Manufacturing Practice initiative, which aims to integrate quality into the product, it is essential to base the selection of scale-up batch size on scientific principles and risk assessment as part of the product development program. Scale-up should be viewed as an integrated activity, not in isolation. This article will explore various tools that can be incorporated into quality by design for the flexible selection of batch sizes during scale-up.
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