New developments and trends in the regulatorischen area

New from the European union (European Union) draft of one I Q 11Als addition of I the Q 8 published the EMA a draft of one I Q 11 for commentating, which with the development of chemical-synthetic and biotechnical active substances concerns itself. Because of the very abstract and general representation of the requirements these are already described in the draft on the basis of five examples. To the Sicherstellung of the Active Pharmaceutical Ingredient (API) - quality in the draft two development beginnings are represented, which klassischer" as �; and/or as � erweiterter" Beginning to be introduced. The requirements of both beginnings as well as their fundamental differences and advantages in the context of permission and also for the manufacture practice of the API are described. http://www.ema.europa. eu/docs/en_GB/document_library/Scientific_guideline/2011/06/WC500107636.pdf" Concept PAPER on the need for A guideline on process validation OF medicinal products containing biotechnology derived protein as active substance" After a Concept PAPER intends the EMA the independent production of a Guideline with requirements to the validation of the biotechnological active substance production. At the beginning of of 2012 for six month's commentating available draft is planned as recapitulatory and more concrete assistance to applications for admission and is the past requirements which I to supplement, but if necessary also new concepts contained. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/06/WC500107128. pdf-ask and answers to the selling of WirkstoffenIm framework of PIC/S the EMA some questions and the pertinent answers published, from which some innovations result also for handling German authorities. The insight of authorities into documents to acquisition, storage, packing, Inverkehrbringen and the other whereabouts of drugs, permitted by the AMG with inspections, is valid also for active substances. Since permission for the insight is valid independently of the purpose for the production of these documents, also fiscal documents can be seen in connection with the selling by active substances. In the future drug manufacturers all must at a distribution chain took part to audit. Even if the manufacturer of API for their packing, storage and transport (- conditions) is responsible, the drug manufacturer cannot appoint itself to their responsibility. In accordance with European Union guideline 2001/62 it has to convince itself of the adherence to the Good distribution Practice (Union of Police) by audits. Analysis certificates for active substances are to come in principle from the original manufacturer. On changes of the API by treatment, Umverpackung or re-identifying other requirements result to certificates. During the marking the possibility for the complete backtracing of the product up to the original manufacturer remains. During the change of kind and size of packing of API�s additional stability examinations are necessary. With renouncement on that a documented justification for the renouncement is to be examined in the framework of audits. Revision � of the Guideline on Stability Testing for Applications for variation tons of Market Authorization" The classification of variation certified preparations after regulation 1234/2008 makes a revision of the above mentioned Guideline necessary to the stability examination of products concerned. For this the EMA published recently a draft to commentating. It contains regulations for active substances (including vegetable) and preparations as well as from this resulting finished drugs. Radio medicines, Biologika as well as biotechnological materials are not included. For type 1, A and b variation are described fundamental defaults. In cases of type 2 variation as a function of their kind and influence on the durability detailed data are described to the additional examinations necessary in these special cases. The commentating phase still runs to at the end of January 2012. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/07/WC500109470.pdfEntwurf of a revised version of the Good distribution PracticesSeit in the middle of the yearly is present a new draft submitted by the European Commission on the Union of Police guidelines for commentating. The possibility for commentating still exists to end this yearly. The revised version is to then step six months after its publication into force. The draft strives widens going adjustment of the Union of Police to the regulations of GMP on and thereby substantially in extent increased, since with the subranges one deals in detail. Also characteristics of the industry are in detail treated, how: Enterprise of the wholesale supplier qualification qualification of the customers export of drugs objections backtaken drug falsifications of recalls activities on behalf transport and transport container BrokerDer draft contains a whole row of new regulations, which might lead to clear cost increases, to the increase of drug security to however hardly contribute might. http://ec.europa. eu/health/files/eudralex/vol-4/2011-07_gdpguidline_publicconsultation.pdfGMP-Inspektionen within the EUDie EMA submitted in the July of this yearly the revised defaults for the execution of official inspections in the member states. They serve for to the further harmonization and better co-ordination of national and central inspections. At the same time a better load distribution aimed at the time of execution between all members as well as a better central data acquisition of the results, also with the supervising authorities of the USA and Australia. The revised regulations are as follows structured: Quality of system Framework for GMP Inspectorates Procedures Related ton rapidly Alerts Procedures Related ton of GMP Inspections Procedures Related ton of Union of Police Inspections Procedures Related ton of Centralized Procedures History OF CHANGE ton the Compilation OF ProcuresNeue instruction for procedure 15 1101 the ZLG to HerstellungserlaubnissenAls responsible authority adopted the central office of the countries for health protection (ZLG) in the June of this yearly a revised instruction for procedure for the distribution of manufacture permissions, now the changes of AMG and AMWHV concerning the responsible persons for production and quality control consider. Also the use of the European Union widths computer data base was taken into account. After request for the distribution of a manufacture permission first a Erforderlichkeitspr�fung is to be accomplished. In case of of assigned enterprises the competence of the authority as a function of the situation is to be examined or the enterprises, also under use of the European Union data base. Only with own competence also its own qualification test takes place. Purpose and arrangement by buildings and areas are to be occupied by collecting main from physical planners to. Their suitability as well as the existing quality control system are evaluated during the decrease investigation. The evaluation and decision are accomplished with the help of a check list. For the distribution of permission a prescribed format is to be used. In it the permitted activities, Darreichungsformen are and perhaps individual drugs specified. Likewise release-relevant examinations are to be indicated. The qualification and practical experience of the leaders by production and quality control are to be examined. In special cases the AMG determines include the federal upper authority, which possesses however no own right for malfunctioning permission for the distribution of permission. https://www.zlg.de/index.php?eID=tx_nawsecuredl&u=0&file=fileadmin/downloads/AM/QS/15110104. pdf& hash=3bdc24b65d383e5878035433512fd03bNeue Guideline of the WHO to transfer of technology in pharmaceutical HerstellungDas the above mentioned document appeared as part 961 Technical report Series and is occupied with the transfer of technology in the production and particularly also in quality control. Transfers in the ranges are treated: Development - > Routine production location - > Location routine production - > Service performance ground electrode range of application extends to active substances, Bulkware and finished drugs. Basic condition for all activities is a detailed contract between transfer givers and - takers as well as a transfer plan. The Guideline deals with all details of such a transfer plan and describes these for the ranges of application mentioned, whereby the transfer of analysis procedures takes a particularly broad area.

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