Standard Operating Procedure (SOP) for Media Fill Validation in Sterile facility. A “media fill” (sometimes known as a “process simulation”) is the performance of an aseptic manufacturing procedure using a…
Chromatography is a laboratory technique for the separation of a mixture. The mixture is dissolved in a fluid called the mobile phase, which carries it through a structure holding another material…
Standard Operating Procedure (SOP) for the handling of Pharmacopoeial Change at Drug Product Manufacturing Location. Handling when Pharmacopoeial changes in monographs and appearance of the new monographs for drug substances,…