Are you asking what makes a development batch a potentially representative batch for a material / product that eventually goes commercial or for another development batch or just in general?
That is a fairly general question with a lot of different variables to consider. If you think about formulation, CPPs, CQAs, suppliers, etc. I think it largely depends on what you are comfortable technically justifying and supporting with any appropriate regulations, health authority, USP or other validation / development data as applicable. Wouldn’t it also depend largely also on what your intention was for your lot to be a representative of if not equivalent to? Just thinking you would clearly have more flexibility with A.D. or R&D batches versus registration / commercial.
Michelle Wichert
These are my own thoughts and not those of my employer.
