Current changes in regulatorischen areas 2012

In draft of change of Germany to the drug law (AMG) the Federal Ministry submitted a bill, with which the AMG in addition, various other drug-relevant regulations are to be changed. Substantial innovations are not contained, since it concerns adjustments predominantly to well-known demands out of EUROPEAN UNION guidelines. The 12 articles of the bill concern themselves with the following ranges: � Drug law � Pharmacy law � Bet�ubungsmittelgesetz � Cure advertising law � Designation regulation � Operating regulation for drug wholesale establishments � GCP regulation � AMG Anzeigeverordnung � Drug and active substance manufacture regulation � Medicine product law � DIMDI drug-regulation-various changes within the ranges mentioned possesses however influence on GMP and Union of Police and is therefore to be considered: � Falsified drugs � Falsified active substances � Marking of drugs � Security characteristics for drugs � Notification procedure for drugs � Serums � Explanation to active substance GMP with the permission documents � Auxiliary materials � Supplier qualification � Qualification of drug wholesale dealers � Drug switching � Omission of the BezeichnungsverordnungInternationalICH GuidelinesDie quality implementation Working Group published Guidelines explanations, which are to facilitate the conversion and interpretation of these guidelines for users from industry and authorities to current I. A current document describes special questions to quality by to Design (QbD). Large value is put on the explanation of terms in connection with quality Risk management and the practice of the risk evaluation. In addition details follow further part of the document to application and approach as well as the extent in practice the Risikobewertung.Im details such as load release, QbD in the permission, models for QbD studies as well as approach during process validation with consideration of the basic principles of the Guidelines Q8 and Q10 are described. New of the World Health Organization (WHO) the WHO published a new and very extensive Technical report, which contains many clarifications to technical questions in connection with the production of drugs as result of a conference. The report is arranged into 15 appendices, from which however only one part concerns itself with GMP relevant questions. It obtain the impression that the WHO would like itself to develop to a link for the international harmonization. Some general changes with WHO-GMP are: � The release Procedere for of the WHO characterized and refugees the reference standards were changed, as well as and thus accelerates adapted to the European standards. � The GMP manual was supplemented around the chapter Product quality Review and the basic principle of a quality unit, consisting of quality control and quality assurance, was introduced. An adjustment took place also here to the defaults of the European Union and FDA. � Additionally to the Site agreeing with the European Union-GMP-manual master file will contain a Laboratory information file with data substantially in more detail to equipment and activities of a test laboratory. Further four of the annexes of the Technical of report contain however more extensive and GMP relevant changes: Good Practices for Pharmaceutical Microbiology LaboratoriesDie WHO supplemented its Good Practices for pharmaceutical quality control of laboratories by special GMPs for micro-biological Kontolllabore. The descriptive requirements orient themselves in particular at those of the sets of rules of the European Union and the FDA with the following ranges of application: � Sterility test � Proof, isolation, identification and qualification of microorganisms in product and with the environment monitoring � Endotoxinbestimmung � Assays with micro biological test system that set of rules is arranged and basedly into 12 detailed chapters as well as five appendices on bases in line with standard usage and scientific. Supplementary Guidelines on GMP `s for HVAC system for non sterile Pharmaceutical Dosage FormsIn an annex to its Technical report published the WHO general principles of their GMP manual for HVAC systems with the production of non-sterile medicine forms. For dangerous products these are not valid however, since for this special own rules exist. All measures are to serve the protection of personnel, product as well as environment. The actual requirements for an appropriate HVAC system are to be specified after risk-based principles. From this requirements result on: � Definition of the class of area � Kind of the air filtration, temperature and humidity � Change of air rates � Air flow � Arrangement of the air-locks, differences of pressure � Dust and UmweltschutzEs detailed defaults made concerning. the organization of the pure classes of area, the kind of the filters which can be used, arrangement of the premises as well as start-up and qualification altogether the descriptive requirements go substantially over those of the European Union-GMP-manual in addition, beyond those the FDA, whereby particularly the demanded employment of High Efficiency Particulate air (HEPA) - and technically probably to justify its d�rfte.WHO Guidelines on transfer OF Technology into Pharmaceutical ManufacturingEin further annex to the Technical report of the WHO is noticeable to filters for ranges for the production of non-sterile medicine forms does not concern themselves with the transfer of technology of production processes and the associated analytic methods for drugs. The production of active substances is not also included. Since the responsible organizations in Europe and the USA set up so far no or hardly regulatorische demands in connection with transfer of technology, the submitted Guideline is the first official collection of principles here which can be being been considering. Naturally this collection cannot contain very much detailed defaults, since the requirements must be always adapted to the individual case. Some fundamental principles are to be considered however: � The transfer of technology concerns handing over and taking over partner equally and must by a written agreement be regulated. � Are to be provided a project and a detailed transfer plan, whereby the principles of the risk management are to be considered. � The abilities of both parties must be comparable and examine deficits. � The state of training of the personnel must be comparable or adapt by training. For the conditions within the individual ranges of the taking over enterprise, which can be considered, the Guidance contains important details and surely represents thereby a valuable guideline assistance, particularly since probably on the fact it is to be counted that the authorities of the European Union and the USA do not remain dormant in this area werden.WHO Guidance for STORAGE and transport OF time and temperature sensitive ProductsDiese in their annex 9 published Guidance are not when superordinate set of rules to the national Regularien of GMP to regard Union of Police and GSP must keep the primacy. It is addressed to authorities, logisticians/feeders and coworkers by pharmacies/occupations of welfare. It contains both mandatory and only desirable defaults, which contain very detailed requirements to all aspects of the sensitive products concerned by storage and transport how: � Requirements of transport containers and transport vehicles � Measuring and controllers as well as their qualification � Area � Documentation � Emergency measure altogether the set of rules places one up to few aspects an almost complete summary of the requirements which can be supplemented at storage and transport of these sensitive products after the present conditions to that

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