Batch Planning BMR Dispensing Validation Media fill Sterile Liquid injectables Batch Manufacturing Ø Must work in sterile manufacturing facility at least 70 % experience in sterile manufacturing lyophilization Ø Faced regulatory audit Ø Team handling Ø Knowledge about bulk compounding Ø Auto clave, reprioritization Ø Aseptic, Behavior and maintenance of the area Ø Aware about the good manufacturing practice for sterile manufacturing Ø Preferably FDA approval for the aseptic manufacturing
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