Technical Risk Considerations of Manufacturing Site Changes of Chemical Solid Oral Dosage

Drug manufacturing site change is the most complicated situation which may combine with changes of formulation, supplier of active pharmaceutical ingredients and excipients, manufacturing process, process parameters, batch, and other registration administration matters. The article discussed the technical risk considerations of chemical solid oral dosage of manufacturing site changes and described the relationship between critical quality attributes and critical process parameters or key control indicators according to specific examples, which in order to provide reference and inspiration for how to carry out research when pharmaceutical manufacturers change their production sites.