Manufacturing and control of active pharmaceutical ingredients (APIs) and excipients (4 credits)
Carla M. Caramella
Contents: How to submit information on APIs (Active Pharmaceutical Ingredients)  to the Regulatory Agencies. ASMF (Active Substance Master File) of the API. The active substances and the Pharmacopeia. The Certificate of suitability to the European Pharmacopea (CEP) and the Certification Procedure. The API’s synthesis, the critical process and material parameters, the in process controls, the issue of starting materials and their definition. The control strategy for impurities. The industrial manufacturing of APIs and the GMPs. The control strategy of excipients. The new excipients and the quality/safety issues. The excipients and the relevant GMPs. The atypical APIs. The manufacturing of sterile pharmaceutical ingredients.
Learning ability test: written exam.