GMP Trends and Analyses!

06.10.2008

FDA'S NEW REQUIREMENTS ON PROCESS VALIDATION - AN OUTLOOK ON THE NEW FDA GUIDANCE

Industry has already been waiting for the new Process Validation Guideline as the current version has been effective since 1987. At the PAT Conference conducted in Heidelberg end of October, Jon Clark from the FDA gave an outlook on the revision. Please read more here

06.10.2008

GMP UNDER RECONSTRUCTION

During the second GMP Conference which took place in Heidelberg, Germany, in June 2007, it showed that the European Medicines Agency (EMEA) as well as the American Food & Drug Administration (FDA) intend to modernise the requirements relative to GMP fundamentally. But what has really changed since then? Please read more here

VOLUME I: PRE-FILLED SYRINGES

During courses and conferences authority officials and industry experts regularly answer questions from attendees - this time relative to pre-filled syringes. Please read more here

06.10.2008

QUALITY BY DESIGN - AN INTERDISCIPLINARY SYSTEM FROM DEVELOPMENT TO REGISTRATION AND PRODUCTION

Quality by Design is not at all only an approach limited to one area. Much rather it should be seen as a holistic system covering all phases from development to production and providing a much more thorough product and process understanding. Please read more here