GMPs for Pharmaceutical Excipients 27-28 April 2010 Hamburg, Germany 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 1521,--) Book this option: IPEC Members (EUR 1521,--)
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Objectives This course is designed to explain the particularities of pharmaceutical excipients manufacturing and distribution and gives an overview on GMP and GDP requirements appropriate for excipients. Specialists from the pharmaceutical industry and excipients manufacturers will share their expert knowledge on all important aspects relevant for producers and users of pharmaceutical excipients. You will learn how suitable GMP and GDP standards for excipients may look like how to use risk considerations as a key point of supplier qualification how excipients can be classified and which auditable standards and certification schemes can be used In parallel workshops you will elaborate and discuss case studies and practical examples. Background With the implementation of the EU Directive 2001/83/EC into national law, all active pharmaceutical ingredients and the yet-to-be-defined Certain Excipients used in pharmaceutical manufacturing must be produced in compliance with current Good Manufacturing Practice (cGMP). As the current regulation is limited the legal enforceability is and will remain difficult. There is no Commission Directive on GMP for certain excipients for the time being and the preparation of such a Directive will not be continued as originally foreseen in Article 46(f) of Directive 2001/83/EC. However a series of recent incidents with tragic consequences for public health showed excipients of substandard quality to be involved and presents a global challenge for both the producer and user of pharmaceutical excipients. Against the background of the current situation the need of compulsory quality standards for manufacture and distribution of pharmaceutical excipients is quite obvious. However due to the considerable complexity of the supply chains GMP and GDP requirements for excipients should be appropriate and not simply mirror those developed for active pharmaceutical ingredients.