Parametric release and real-time release testing Full Text
Pharmaceutical Technology, 06/29/2012
Compliance with release specifications can be demonstrated by performing a complete set of tests according to approved specifications before the final product is released onto the market. Under certain conditions, however, it is possible to use an alternative strategy called parametric release. Rather than conducting an approved sterility test, parametric testing involves utilizing information collected during the manufacturing process to demonstrate that the product was made according to defined GMP and sterilization procedures.