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Solid Oral Dose Process Validation

Jordan Collins , Emilija Fredro-Kumbaradzi , Ajay Babu Pazhayattil , Naheed Sayeed-Desta

Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory...