Extended package to GMP and beyond

https://www.crystalpharmatech.com/analytical-method-development-validation/

Why Analytical Method Development and Transfer is required？
Well-developed analytical method development for biologics are required to characterize quality attributes of biologics. These analytical methods also help to understand the critical process parameters and to minimize their impact on accuracy and precision. Biologics analytical method development and validation could be intricate, labor-intensive, and expensive in nature. An in-depth knowledge of FDA, ICH, and regulatory expectations along with the application of advanced instrumentation is critical to developing robust, efficient, and accurate analytical methods. These methods should encompass the regulatory domains of identity, strength, purity, stability, safety, and potency of biologics at every stage of the drug development.