Current regulatorische changes in the European Union and pieces of news within the range of sterile medicine forms

In the EU�nderungen with the ArzneimittelzulassungenAm 1 January 2010 the new regulation 1234/2008 stepped current regulatorische changes from 24 November 2008 over the examination of changes of the permissions of human and animal drugs into force. It serves the harmonization of the valid national and European procedures to the change at drug permissions. Because of the particularly high number of only national certified drugs (approx. 85%) for � the 29 of the drug law (AMG) so far to use is, exists here need for action, since it comes here occasionally to deviations of the European Union defaults. The conversion of this regulation was however only published effected to January 2011 with the introduction of the guideline 2009/53, at the end of of 2009 and their extensive annex detailed information for the categorization of possible changes and requirements for their requests for modification contains. The new European Union regulation essentially regulates the following points with existing permissions: Organization of the changes into the classes IA, IA/IN, IB and II with appropriate requirement possibility of the summary of several change definition new, shortened periods for applicants and authority reference to guidelines for the categorization of changes and the one which can be then used all permissions starting from 1998, are to be treated starting from 20 January 2011 according to the new guideline 2009/53. Older permissions are not concerned. Purely national permissions are likewise concerned and are subject to national regulations. A revised internal document with basic rules for the validation of aseptischer processes made pieces of news within the range of sterile medicine form validation aseptischer ProzesseDie PIC/S commission public. It contains detailed criteria for the evaluation of growth medium fillings of the most different sterile products and deals with their characteristics. It is to be assumed the requirements defined here are taken up shortly also in the Annices of the GMP manual. Apart from the basic principles of the growth medium fillings the document contains the following chapters: Characteristics for the DarreichungsformenTestdurchf�hrungN�hrmedienInkubationsbedingungenH�ufigkeit of filling evaluation of the result environment monitoring qualification personnel containers of the Closure Integrity TestingSterilisation of containers, plugs and component filter Integrity TestingDesinfektionIntegrit�t of this updated document gives thus a detailed guidance for the execution from growth medium fillings to simulating aseptischer production processes. It essentially contains the well-known principles of the validation aseptischer production of sterile products. Assistance for the application revised annex 1 Manufacture OF Medicinal sterile ProductsZum 01. December 2009 submitted the PIC/S commission an interpretation assistance for the application in 2008 to changed annex 1 of the GMP manual with the goal of a harmonized application with the inspection of manufacturers of sterile medical products. To be used its defaults are both of authorities into the PIC/S members and into EG-L�ndern.Das document make detailed defaults the ranges: Pure space qualification with data for the frequency of the Requalifizierung as well as the test parameter and methods in the different pure class of area routine monitorings with method-micro-biological MonitoringMedia FillsBioburden regulation and filter Efficasy TestingReinraumbedingungen with the production of Vials as well as their MonitoringDas submitted document represent a valuable assistance for authorities and manufacture ranges, because many interpretation problems are void.

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