by Dr. Yashashwini Reddy | Oct 9, 2025
Elaboration:The development and manufacture of drug substances (Active Pharmaceutical Ingredients – API) encompass all stages from the initial synthesis or isolation of the active compound to its large-scale commercial production under Good Manufacturing Practice...
by Dr. Yashashwini Reddy | Oct 9, 2025
Good Manufacturing Practices (GMP) for APIs are essential to ensure that the Active Pharmaceutical Ingredients produced are of consistent quality and meet their intended use requirements. These guidelines are mainly described in ICH Q7 – Good Manufacturing Practice...
