4. Validation for Freeze-Dried Pharmaceuticals in Clinical Pharmaceuticals Plant(Seminar : Quality Assurance of Bilologicals and Foods, and Safety Programs in their Production)

Abstract

Since an Investigational Drug GMP started on April 1st, 1997, in Japan, process validation for clinical pharmaceuticals production has become to be required. Guideline on sterile drug products by aseptic processing includes ensuring of equipment suitability, water control, cross-contamination control, environmental monitor and media-fill trials. This report is concerned with process validation in our clinical pharmaceuticals plant.