Neuerungen und Trends im regulatorischen Bereich 2010/2011
In the European Union: Actualization of the European Union-GMP-manual, part of 1, chapter 5 and 7 the revision of chapter 5 part of the 1 of the GMP manual serves the stress of the importantness of the delivery chain of raw materials. Sections concern the end of 2010 published changes to chapter 5 for the qualification of basic material suppliers as well as purchases checks: The delivery chain for basic materials is admits and to have documented, permission of the suppliers by quality control and production, suppliers of active substances and critical basic materials is to be audited and their GMP Compliance examined, likewise their delivery way and documentation, the comprehensibleness of the delivery chain part of the purchases check should be, kind and range of the purchases checks is in agreement with the permission documents to take place and be able except the examination on identity on behalf to be assigned. Conditions for the agency of order laboratories are: o order laboratories are to be audited regularly, o of analysis certificates are of qualified representatives of the contractor with reference to the closed agreement to be signed, to o a condition for the acknowledgment of the certificates are three entire analyses to different loads of a basic material and their periodic Wiederholung.Die new regulations are valid also for packaging means revision of chapter 7: Production and examination in the processed-out order the revision chapter 7 resulted from a substantial increase of orders to the production and examination in the processed-out order from the drug manufacturers and from the circumstance that here many activities are not subject to the monitoring by the authorities. For simultaneous adjustment to which I Q 10 has the European commission end of 2010 a draft for the revised version of chapter 7 under the designation � Outsourced Activities" presented, with which an extension is connected on all externally assigned activities. Most important innovation is the attention of the quality risk management during the definition of external partners. The responsibility for the proper execution of the orders exclusively is with the client. Kind and range of the qualification lie in its responsibility. All met measures are to be documented and are subject to control by the authorities with client new since January 2011: Site master file, extension of the GMP manual on part of III the European commission introduced recently the revaluation of the Site master files with their admission as part of the quality management documentation. As first Guideline of a part of III which can be created again to the GMP manual contents � of the PIC/S PE become 008-4 Explanatory Notes for Pharmaceutical Manufacturers on the Preparation OF A Site master File" suggested. These are in January 2011 into force stepped and already in practice of various companies are converted. The Guideline PIC/S PE 008-4 is clearly more comprehensive than its previous version and contains innovations such as PAT, quality by Design, Design space etc. you in the future a part of the quality management documentation to be and all requirements to GMP fair documentation to be sufficient have. The change of version is justified as follows in the document: � Simplification OF the document and implementation OF requirement related tons of quality risk ate policy" The following additions are to be considered: Quality Risk ManagementPAT, quality by Design, Design space, material time release, Compliance with TSE (Transmitting animal spongiform encephalopathy) GuidelinesDokumentation to the release ProcedereErstellung equipment cunning ruse to wage production and test data to these defaults are to be valid and have in the future also for active substance manufacturers to be adapted accordingly. You find the current PIC/S document under: http://www.picscheme.org/publication.php?id=15Sie would like to experience more over it? Visit the seminar I Q10 in SOPs convert to 24.05.2011 in Wiesbaden: info./up-to-date/topic.asp? kursid=1705" > http://www.pts.info/aktuell/topic.asp?kursid=1705Neues to FDA and PIC/S after initial refusal of the application for membership of the FDA to PIC/S because of substantial deviations between the monitors of the present PIC/S range and the USA their final admission can be now carried out according to appropriate rework. Contrary to a PIC membership and such in the PIC/S this admission does not mean under any circumstances the mutual acknowledgment of GMP inspections, which would have to be regulated in an additional agreement and provisionally be expected is not, since a large adjustment of the GMP standards would be necessary before. To note it is however that the FDA will receive access to firm-specific lack reports by the membership in PIC/S by the exchange of inspection reports. New of the WHO - Technical report 597 the WHO has its newest Technical report was published, the ends of 2009 by the Expert Committee for Pharmaceutical Preparations worked on and from one main document and six appendices exists. The main document contains only a list as well as the announcement, the future publication of two Guidelines of important English terms of the quality assurance: Guideline for Technology TransferWHO Good Practices for Pharmaceutical Microbiology LaboratoriesDie of six appendices are to unite obviously the newest GMP Regularien of the European Union, Japan and the USA, however partly go beyond these. Even if this have no binding character, is to be counted on its far-preserving assumption into the landown defaults. Annex 1: WHO Good Practices for Pharmaceutical quality control LaboratoriesAnnex 2: WHO Good Manufacturing Practices for Active Pharmaceutical IngredientsAnnex 3: WHO Good Manufacturing Practices for Pharmaceutical Products containing Hazardous SubstancesAnnex 4: WHO Good Manufacturing Practices for sterile Pharmaceutical ProductsAnnex 5: WHO Good distribution Practices for Pharmaceutical ProductsAnnex 6: Guidelines on the Requalification OF Prequalified dossier
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