LAUSR

The pilot scale batch size for solid oral dosage forms is currently defined by major regulatory agencies as one-tenth of the full production, or 100,000 units, whichever is larger. The current criteria is arbitrary and is not based on scientific and risk assessment principles. The approach does not consider geometric, kinematic and dynamic changes that come into play upon scale up. Even if this criterion is met, impact of scale up on critical quality attributes (CQAs) cannot be ruled out and also reproducibility cannot be assured simply by restricting the scale up size. In keeping with the vision for 21st Century Good Manufacturing Practice (GMP) initiative to build quality into the product, it is imperative that the selection of scale up batch size be based on science and risk assessment principles and be part of the product development program. Scale up should never been seen as an isolated activity. The article will review various tools that can be integrated with quality by design (QbD) for flexible batch size selection during scale up.