Relatively new regulatory guidelines allow for comparability protocols that can prove equivalency for certain kinds of changes and certain kinds of products. The protocol must clearly demonstrate that a manufacturing change has not adversely affected the identity, purity, potency, or safety of a product. Here's how to go about it.
CITATION STYLE
Simmerman, H. K. B. (2000). Demonstrating product comparability. BioPharm. https://doi.org/10.1007/978-1-4614-6916-2_12
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