Quality Control of Raw Materials 4-5 May 2009 Vienna, Austria Please click here to view the program of this conference or course To book for this program, just click on the option: Book this option: Non-ECA Members (EUR 1690,--) Book this option: ECA Members (EUR 1521,--) Book this option: EU GMP Inspectorates (EUR 845,--) Book this option: APIC Members (does not include ECA membership) (EUR 1605,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
Testing and Sampling of Incoming Active Pharmaceutical Ingredients (APIs) and Excipients Objectives Testing active pharmaceutical ingredients and excipients is one of the main tasks of the quality control units in the pharmaceutical industry. It must be ensured that the necessary tests are conducted on the incoming goods and that the starting materials are released only after their quality was judged as satisfactory. This GMP Education Course about the incoming goods control of APIs and excipients will give you a comprehensive overview of the specific tasks and questions of the „raw materials lab“ and show you real-life solutions and answers. This course will deal among others with the following questions: Who is responsible for the release or rejection of starting materials? How can the incoming goods lab be organised efficiently? Which SOPs are necessary? In which cases can test results be taken over from the supplier‘s certificate of analysis? Do all test items of a pharmacopoeial monograph have to be analysed? Are the pharmacopoeial monographs similar, or must different tests be conducted for PhEur, USP and JP? Can a pharmacopoeial test method be replaced by an alternative test method? Does this require a variation application? It is the aim of this GMP Education Course to give answers to these and many other important questions relating to the testing of APIs and excipients and to serve as a forum for an intensive experience exchange.