Want to get familiar with the API Regulation or Regulation on supply? PCL now offering an online course on the subject of Active Pharmaceutical Ingredients & Active Substance Procurement, Production, Regulation and Supply. In our course, you will be learning on different subjects regarding API & AS which includes, but not limited to the following:
- Registration Requirement for UK Active Substance Manufacturers, Importers and Distributors.
- Licensing Regime for UK Manufacturers, Importers and Distributors
of Active Substances.
- Raw Material, API and Intermediate Sourcing Regulations.
- EU API Importation and the Falsified Medicines Directive.
- API Production and Good Manufacturing Practice.
- API Manufacturer Quality Management.
- API Release & API Certification.
- Good Distribution Practice and Documentation for Importers and Distributors of APIs for Medicinal Products for Human Use.
- MAH Responsibilities.