Manufacture of the finished Dosage Form - QbD: New EMA Guideline The European Medicines Agency (EMA) published its new guideline on Manufacture of the finished dosage form on August 14, 2017. The guideline replaces the “Note for…
VALIDATION OF FREEZE DRYER “In freeze-drying, water is removed from the frozen state by sublimation, i.e., direct change of water from solid into vapor without conversion to a liquid phase”. Used for drying of a…
Process Validation Programme OBJECTIVE : To lay down the procedure for the process validation of products to ensure that a specific process will consistently produce the product meeting its pre-determined specifications and quality attributes. RESPONSIBILITY : Research …
Copy Right Text | Design & develop by AmpleThemes