Risikomanagementsysteme, Sterilfertigung, Kosten senken durch Compliance
Pieces of news of the 16. GMP KonferenzDie I guidelines Q 8 � quality by Design" , Q 9 � quality Risk Management" and Q 10 � quality Systems" entrance into the Regularien found. Thus systematics of the quality risk management (QRM) are described in detail in annex 20 of the European Union-GMP-manual. Among other things this annex contains a multiplicity from methods to the conversion. Now it is valid to fulfill not only the Formalien to use but QRM in practice. Exact process knowledge - the key to the quality risk management (QRM) around the advantages of the quality risk managements to use to be able the following components are important: - Identification of risks their evaluation preventive preventive measure evaluation of the residual risk integration of the quality risk management into the quality management system evaluation of the system vs. Evaluation individual SachverhalteDamit is exact process knowledge � of the Schl�ssel" the quality risk management. Examples of the application possibilities are within all ranges: whether process validations, production, computer-assisted systems, plant qualifications, data archiving or training courses. Possible quality risks can be identified in such a way and preventive measures be installed. It is noticeable that with treatment of deviations and in risk evaluations the factor � Mensch" to be often not sufficiently considered and the individual errors not be regarded. Meanwhile do the enterprises have quality risk management QRM SOPs, but � are also gelebt"? Inspection experiences show: Despite all advantages quality risk management is not yet sufficiently used. Quality risk management cannot only be merged into the existing quality assurance system, but supplements this outstanding. And fast, concrete handling risks and in particular events shows up strengthens the efficiency of such a system. The use of feedback systems is helpful thereby. In addition belong the regular evaluation of risks, which repetition of the evaluation after risk-reducing measures, which contains periodic evaluation of risks (Product quality Review) as well as further feedback MechanismenGood distribution PracticeDer distribution process of drugs, intermediate products and effect and auxiliary materials possible risks and accompanied by quality influencing factors. In this connection is referred also to the extreme increase of illegaly introduced medicines and drug falsifications. Risk-minimizing measures work like control of the site conditions (cleanliness, admission, storage and transport) - certificates of identity for the defense of falsification Herkunfts and receiver oh way legality and intended purpose from regulatorischer view the long expected revision of the WHO Good distribution Practices and the guideline 2001/83/EG.In of Switzerland appear helpful need each company for the wholesale with drugs, intermediate products as well as effect and auxiliary materials in Switzerland a grant by Swiss Heilmittelinstitut Swissmedic on the basis of the cure law. This grant obligation is valid equally for the import and export as well as for drugs, which are used for clinical examinations. The condition for the market release is the so-called trading licence, whose conditions are in detail in the drug grant regulation fixed. After fulfillment of all legal conditions to the grant an order for inspection is then issued of Swissmedic to the responsible regional specialized place, RFS. The grant distribution takes place afterwards via the Swissmedic. At present 695 enterprises in Switzerland order over a grant import (inclusive and exclusive market release) - wholesale in Switzerland (inclusive and exclusive market release) - driving out trade in the AuslandZu the emphasis of an inspection to this Union of Police rules belongs the supplier qualification and the Transportvalidierung.GMP aspects of PharmawasserZu the references about Pharmawasser belongs the regulatorischen requirements, practice and inspection experiences, micro-biological aspects and the so-called Rouging, the laminar corrosion on high-grade steel surfaces. The extensive regulatorischen bases and sets of rules of the European Union, the USA, Japan, WHO, resemble each other contentwise, do not agree nevertheless. There are numerous standards and Guidances as well as industry standards in the Pharmasektor, which illustrates the conditions of science and technology. Guide to the quality control of Pharmawasser is the European dispensatory with data to specifications, quality parameters, testing methods and limit values. The quality inspection by a conductivity measurement supplies obviously again and again discussion material to inspections. Conductivity measurement belonged for example apart from micro-biological questions such as bio film, Sanitisierung and Rouging to the emphasis with inspections of the years 2009/2010. With the examined enterprises the problem bio film is differently concerned. Thus as a function of the necessary water quality very different approaches are selected for the treatment and fight against bio film formation, and used a multiplicity of possible and combinable measures. A further, at present however rather problem in the background is the Rouging, reddish, ferric oxide-rich particles on the high-grade steel surface. A problem for it so far still no simple and comprehensive problem solution gives. With consideration of all possible preventive measures an risk evaluation is necessary, which gives information over the possible dangers for humans, product and plant. To the preventive measures examinations, technical measures and the letter of a standard work instruction (SOP) belong about Rougingmonitoring.GMP update - revision of the European Union-GMP-LeitfadensDer European Union GMP manual part of I is revised at present. With the implementation of I Q 10 � companies quality System" into these two first chapters of the manual in the future the emphasis is put on the installation of Managementtools and the senior management is more comprehensively merged, than it was so far the case. Strengthened in the future the entire system and its interfaces are regarded, the far over product quality Review (PQR), expected so far by the authorities, outside. System-spreading managements a Review is expected, beginning with the purchase up to the delivery of the product. Like that are in the focus: - Quality management system quality Assurance Process performance and Product quality monitoring system and Product quality Review management OF Outsourced Activities and Purchased material management Review and quality management system monitoring OF Internal and eXternal Factors Impacting the quality management system Outcomes OF management Review quality Risk management-clearly more strongly is put value to evaluate and in such a way evaluate the determined data statistically with the goal whether the system is sufficient and also functional. With the extension of chapter 2 European Union of the GMP Leitfades is considered to that Consultants are used strengthened, and frequent changes in the product possession to take place. The responsibility of the management stands in the focus than it so far the case was stronger. The implementation quality risk management represents a further change. So far was only optional the quality risk management described in annex 20 to use. In the future with implementation of I Q 10 the installation of a quality risk management system to the requirements will belong. Still in the stage of the revision are the chapters 3 and 5th in particular to the topic � Dedicated Facilities" have the members of the Inspectors Working Group (IWG) still no uniform attitude. Only a fundamental consent could over the creation of a toxicological � Tools" to the evaluation of the substance risk to be found. So far however an individual case evaluation necessarily becomes by the authority, which includes an risk evaluation and the judgement of an toxicologist. Still in discussion are also additions of the chapter 5. Here are in particular around, supplementing regulations to active substances and unite to auxiliary materials harmoniously the past regulations to adapt and these by a API Pedigree Concept, i.e. the documentation of the delivery chain up to the original manufacturer to supplement. The implementation of I Q 10 " Management OF Outsourced Activities and Purchased Materials" into chapter 7 " Order production and Pr�fung" already far prospered. Like that the consultations are already final to the EMA scribbling paper. Quality risk management will be also a topic with the revision of the European Union-GMP-manual part of II, in which the principles which I Q 9 � quality Risk Management" are transferred. The still which is pending extension of the European Union-GMP-manual by part of III is planned as a collection of Best Practice documents. These are to supplement the regulatorischen requirements and to support regulatorische processes (e.g. inspections). In addition for example documents belong like I Q 9 (at present annex 20) and the addition through I Q 10 (alternatively annex 21), a load release certificate and an updated Site master file falsification of drug after data of the customs authorities increased alone in the years 2005/2006 the number of konfiszierten falsifications at the European Union external borders by 384%. Increased also falsifications in the legal distributor chain are registered, however still on a low level. Only not falsified so-called � Lifestyle medicines are discovered, but also increasingly vitally necessary Arzneimittel.Als reaction to the increase of the drug falsifications is prepared at present for initiative of the European commission a drug falsification guideline. Still Angedacht are not instruments to the better recognition of falsifications like the intensified application of the GMP rules on active substances and possibly on auxiliary material the expansion of the inspections of active substance dealers, in particular in third state the improvement of the security characteristic a stronger obligation of the wholesale dealers (including brokers) exist agreement within the working group of the European advice, which discusses at present still controversially. To the selection and priority of possible measures a risk-based approach is recommended. To consider participate: - Price and quantity sold of a product number of falsifications within and outside of the EUROPEAN UNION development of the occurrences in the past special characteristics of product concerned weight of the disease picture concerned as well as other possible health not to underestimate are the costs, which develop with the manufacturers concerned, importers of drugs, pharmacies, wholesale dealers. Thus within the advice working group a repacking prohibition was suggested. A measure, which would increase the costs by 3,2 to 4.5 billion euros, would lead to omission of many jobs and to distortions of the price competition in the health service. A proposal, which was already rejected for these reasons mentioned. As inexpensive and simple solution type the Serialsierung still presents itself frequencies identification (RFID) or bar code to a falsification safe coding by attachment by means of radio. To consider it is that by these securing measures at present the constantly growing (illegal) sales way is not contained over the Internet. Annex 1 - a new epoch in SterilfertigungDie new regulations to the sterile manufacturing of drugs annex of the 1 to the European Union-GMP-manual in the year 2009 were published. A part of it, like the regulations for locking the Vials (Capping) only in the spring into force stepped this yearly. Altogether with these new regulations a risk-based approach is pursued. A highest goal is according to the minimizing the risk for a micro-biological, individual and/or pyrogene contamination of the Produkte.Es becomes quality standards like e.g. the organization into categories of purity and their requirements details fixed. Otherwise the approach in the ranges and operational sequence concerned is treated according to the principles quality of the Risk management. Possible risks are: - aseptische procedure insulator Blow, Fill sealing plant sterilized final product personal equipment cleaning production process of sterilisation procedure Qualit�tskontrolleDie changes annex of the 1 to European Union the GMP manual actually represents a new epoch of the sterile manufacturing. With the stress of the quality risk management the sole responsibility of the acting persons is strengthened, without limiting their scope of action by detailed defaults. Costs lower by ComplianceQuality Assurance (QA) in the enterprise rather as cost factor are seen multiple. It can make however through creation of more Compliance a large and important contribution for the reduction of costs of an enterprise. An important condition for it is the organizational integration of the quality Assurance in the production enterprise as well as the motivation of all coworkers. In this new quality system the past conservative, reactive way of acting is replaced with handling errors and lack from an per-active way of acting. The past image of the quality Assurance bureaucratically, inflexibly and thus � Innovationsbehinderer" to be, changes thereby. The quality Assurance is merged closely, linked into expirations and processes with the goal of improving the Compliance and of realizing with it saving potentials. The education is important key sizes fixed by Leadership teams including the quality Assurance and the development of superordinate targets and their consistent progress control by. These principles of the holistic improvement process are not new, yet they are not always successful with application. Thus there is a set of principles, to whose observance and fulfillment should be absolutely paid attention. In addition belong: - Definition of clear responsibility assistance with change report collection all inclusion exact goals giving reached goals beyond the goal pursue-takes place via ideas and innovation must be communicated, so that they are converted into further motivation. R. Schnettler is leader of PTS training service, Arnsberg, C. Wawretschek is free woman employee with PTS training service �
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