Analytical Test Methods. 3.1 Shasun shall be responsible for demonstrating the validity of all methodology used for in-process control, and release of process materials, intermediates, and API. This validation shall be established, through approved protocol and final report, based on the current ICH and FDA validation guidance documents. Method validation shall be performed consistent with Shasun-approved procedures.
Appears in 2 contracts
Sources: Supply Agreement (Reliant Pharmaceuticals, Inc.), Supply Agreement (Reliant Pharmaceuticals, Inc.)