Solid Oral Dose Process Validation
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 guidance''s and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus ...
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 guidance''s and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus ...