Seminar Nr. 16894
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This special course offers you a unique possibility to become acquainted with the new regulatory requirements of the revised Annex 1, the impact on aseptic manufacturing and the challenges relating to quality aspects.
Authority speakers as well as representatives from pharmaceutical industry will provide you information about their thinking about the new requirements . They will discuss the statements of the new Annex 1 on topics like Quality Risk Management, Process Simulation/Media Fill and Container Closure Integrity Testing, as well as the current expectations on premises, cleanroom qualification and the appropriate monitoring.
Additionally, the speaker will compare the requirements of the new Annex 1 with the expectations of other guidance documents like ISO 14644 or the relevant US guidelines.
The Annex 1 “Manufacture of Sterile Medicinal Products” was published for the first time in 1971. During the following years it was updated several times, as example to align classification table of clean rooms, to include guidance on media simulations and bioburden monitoring in 2005 and 2007 or relating to capping of vials in 2010.
But the currently published document represents for the first time a complete revision wit the focus to give a more structured guidance, including state of the art principles like Quality Risk Management and pay attention to new technologies and innovative processes. It includes now new sections, as example for utilities and enlarged topics like production and specific technologies or an increased guidance on the requirements of Aseptic Process Simulation (APS).
This conference is of interest to professionals from pharmaceutical and biopharmaceutical manufacturers, authorities and suppliers with responsibilities in
Structure, Wording, Definitions - the current Draft