Guideline Meeting - Die Community trifft sich in Stuttgart zur Diskussion
Guideline meeting information and pieces of news around pharmaceutical sets of rules are located approximately in the center of the meeting. The Guideline meeting is offered apart from current innovations, pharmaceutical sets of rules and laws, which are treated within lectures, the possibility, in particularly for it furnished discussion and discussion rounds of exchanging with authority representatives and of discussing questions. Annex 11 and chapter 4 to the EEC-GMP-LeitfadenIm April 2008 the Draft new annex of the 11 was published of the EMEA for public commentating. The extent multiplied in relation to the current version. Due to the contentwise connections with the annex 11 also a draft was at the same time presented for the change chapter 4 of the EEC-GMP-manual. The commentating period for both documents ran off in October 2008, at present is both documents in the phase of the treatment of the many been received comments on specialized level by " drafting group". It can be assumed the result of this revision is present still in the first half-year. Contentwise very much changed: Risk management is embodied in the annex 11, to the validation of systems is contained partly very concrete defaults, which kindled already violent discussions. In addition, topics like electronic signature and� Assessment of suppliers are - in not undisputed way - adapted to the more modern conditions. Further topics with explosive are also Inventory, audit Trail and Printouts.�I Q 9/annex 20 � quality risk management in the year 2003 discharged the members which I a new quality vision. In the center of this vision on the one hand the risk-based and scientifically justified procedure is located. On the other hand it is made clear that for it an adequately installed quality system is necessary.�The guidelines for pharmaceutical development (I Q 8), to the quality risk management (I Q 9) and the pharmaceutical quality system (I Q 10) were compiled, whereby which I Q9-Dokument as link between the sister documents serves. Since March 2008 the contents of which are I Q9-Leitlinie into the annex 20 of the EEC-GMP-manual taken up and implemented. New it was also that the annex 20 carries an only optional character and its contents serve the pharmaceutical enterprises as an assistance during the concept production. �At the same time again in chapter 1 of the� EEC-GMP-manual inserted section makes clearly that the arrangement can quite vary of quality risk management systems, however the implementation of such a system for all pharmaceutical manufacturers mandatorily for ist.AMG NovelleIm December 2008 published the BMG, for many at this time surprising, the ministerial draft bill of a law to the change of the drug law and other regulations. This - of many as 15. AMG novella designated - change serves, not only the adjustment at European Union regulations to new therapies and child drugs, but takes up also experiences from the conversion of the current legal situation. There are e.g. many topics, which can have substantial effects in particular due to partly which are missing transitional regulations, like omission � of the 4a No. 3 AMG in connection with a change � 13 AMG, permission obligation for drug examinations, revised version of the conditions for special customer in � 15 exp. 3a AMG, concerning several changes fabric preparations and supply obligations for the pharmaceutical entrepreneur. Even the drug definition is changed in the novella. Violent discussion topic before are also the changes for the production of patient-individual preparations. Meanwhile also a hardly changed cabinet draft is present to the law. The first reading in the Bundestag is at present for the 19. or 20. March 2009 intended.�Execution of growth medium fillings with consideration European AnforderungenDie aseptische production is one of the most critical process steps in drug production. The validation by means of growth medium fillings is always located in the focus of the inspections. To 1. March 2009 came into force the new annex 1. The defaults must be converted. Process validation - current European SichtweiseDie past view on the pharmaceutical production processes proceeded frequently from a static process, D. h. one on the part of the parameters etc. � frozen � operational sequence, which can guarantee exclusively the quality of the drugs. This perspective determined also the procedure within the range of the validation - aligned to the fixed process.�Now the draft ensures for the actualization � of the Guidance for Industry: Process validation - general of principles and of practices � for eddies in the Pharmawelt. But in times of I Q 8-10 and PAT also in the European range the focus increasingly on the life cycle of the drugs and the proof from product and process knowledge to the protection of the product quality and for patient security will thus lie. Our offer for it in April 2009Bei of a registration with the invitation code: rron09, until 20 April 2009, for in May and June 2009 receive the taking place meetings of the ESN academy, you to 250, - euros discount per meeting and participant as well as a coupon for a free participation in a ESN meeting of your choice, which takes place between Septembers and December 2009. These are postable starting from May 2009. The coupon is transferable within the enterprise. (not valid for meetings of the ESN partners)
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