15. GMP conference in Munich: Meeting place for industry, authority and university

The series of lectures to 23. - 24.November 2009 in Munich stretched a far sheet of the pharmaceutical package tied in the European union over the installation from risk management systems to the supplier management. If the meeting was supplemented by panels and Round Tables.Andreas Ellmaier conveyed that to greeting of the Bavarian Department of State for environment and health and Professor Dr. Ingrid Mueller, Hochschule Albstadt Sigmaringen, led by the conference. The course of studies Pharmatechnik of this university was one the organizer of the conference participants from industry, authority and university discussed questions how:��� * How does the European union react to the demand for patient after guarantee of safe, innovative and affordable drugs?��� * How will the adjustment of the European legislation look to the I initiative Q10 Pharmaceutical quality of system? ��� * Did the annex 20 quality Risk management become to the component quality of the system of the manufacturers?��� * How do the pharmaceutical companies and the authorities prepare on audits and inspections?��� * Is the instrument of the supplier qualification how useful? Rules for safe, innovative and affordable ArzneimittelDie at the end of of 2008 on the part of the European Commission seized European Union initiative to the guarantee � safe, innovative and affordable Arzneimittel" different detail goals have to contents: 1. Guarantee of a rapid and affordable entrance to newest Therapien2. Improvement of competition and Marktzugang3. Safer drugs for better informed B�rger3. Use of chances of the globalization and acceptance of their Herausforderungen4. Promotion of the pharmaceutical ForschungRico Schulze of the Saxonian Department of State for social and consumer protection reported in detail on the available three parliamentary bills and their possible contents and nuclear elements: 1. Entrance to information about Arzneimittel2. Stabilization of the Pharmakovigilanz-Systems3. Better protection from Arzneimittelf�lschungenEs proposals to the change of existing guidelines as well as consequences for the practice of the pharmaceutical companies were discussed. Is clear: the rapid increase connected by drug falsifications with the occasionally dramatic consequences, with a not insignificant economic damage, requires a world-wide initiative to their Bek�mpfung.GMP UpdateDr. Gabriele Wanninger, government of Upper Bavaria, directed the view of the conference participants of the current regulatorische innovations. Thus parts of the EEC-GMP-manual are submitted momentarily of a modification. As consequence from the introduction of I Q10 Pharmaceutical quality of system into systematics of the EEC-GMP-manual is necessary the revision of some chapters of the manual. Besides the following Annices is at present in revision: Annex 2 production from biological drugs to application with the people annex 3 production of radio medicine annex 7 production vegetable drug annex 11 computer-assisted system annex 13 production of clinical test annex 14 production of drugs from human blood or blood plasma annex 16 certification by a adept person and load release to the conclusion of their lecture still dealt the Referentin with four further level circles, which are from high value and are in preparing treatment: ��� * Explanations concerning the production of Site master files��� * Proceed with serious Non GMP Compliances��� * Responsibility of the Qualified person (QP) and procedure with Minor deviation��� * Good distribution PracticeSie described sense and purpose of these documents finished and their future classification in the GMP Prozess.RisikomanagementsystemeVon, not placed yet, to its experiences from inspection practice with the implementation of risk management systems reported Dr. J�rgen M�hlitz, government of Upper Bavaria. After its estimate the risk tolerance in our current society diminished clearly after the many negative experiences of the last decades. The patients wish themselves more effective, reliable in addition, harmless drugs. Therefore risk management systems become essential as an instrument of the minimizing the risk. Therefore I was accepted Q 9 as annex 20 to the GMP manual. With annex 20 quality Risk management becomes an integral part quality of the system of the manufacturers. It places internationally recognized management methods and means to the manufacturers to application to the order without a rigid concept with own regulations to be, but is the decision possible for concepts and methods with same objective to quite make. The adviser dealt then still in detail with strategies, execution and monitoring with the implementation of risk management systems and described also expectations to such a system in the detail as well as possible methods for examination its operability after implementation preparation each pharmaceutical company has in the course of a production yearly the most different examinations to exist. There on the one hand the regularly taking place official inspections are, on the other hand by existing or potential contracting parties audits are called in. These activities can accept a considerable extent as a function of firm size and Produktportfolio. To forget thereby - also of the legislator demanded - internal the audits are not, whereby in larger companies local quality functions are supplemented by superordinately settled quality functions and so that the audit volume is possibly increased. Dr. Matthias Bohm, Bavarian Schering pharmaceutical AG, guessed/advised to a systematic preparation and execution of an official GMP inspection, which follows the usually following operational sequence:��� * Inspection preparation��� * Inspection in the enterprise��� * Inspection result and reinforcement��� * Follow UP that measure over outside gave an idea of the practice of an FDA inspection to Dr. Bohm and showed among other things. Behavior rules with authority inspections (the DOS and Don�ts) up. Official GMP InspektionenDamit inspections for both sides - authority such as enterprises - successfully run can do, requires it also from authority side of an extensive and systematic preparation, thus director of pharmacy Dr. Michael Schmidt, directing center drug monitoring Baden-Wuerttemberg-official inspections has its basis in � 64 of the drug law (AMG). In addition the inspector can rely on instructions for procedure (VAW) as part of a federally uniform quality control system of the authority: VAW 071101 providing risk and time-dependent InspektionsplanesVAW 071102 preparation, execution and reinforcement of GMP-InspektionenVAW071108 production and format of InspektionsberichtenDer adviser described the usual procedure, which begins with the production risk and time-dependent schedule of inspections. Dependent on enterprises and type of inspection the inspection expenditure is measured. As direction size the adviser called ten person days for the inspection of a sterile enterprise including preparation and Nachbearbeitungszeiten.Im next step the inspector for the preparation documents will consult. Particularly helpfully here a legally not demanded however document very useful for a view proves: , a current Site master file erstelltes with PIC/S structure. Execution can extend depending upon examination article over several days. The concluding inspection report contains the following apart from general data:��� * Statements/observations��� * List of the errors and lack, connected with a lack classification��� * Recommendations��� * Summary and conclusions!! The inspection report should be dispatched time near to the enterprise. Maximally four weeks are aimed at after inspection. If lack should have been recognized during the inspection, which critical nature are, immediately appropriate measures must be introduced. Other lack are to be eliminated in an appropriate period. For this a statement of the enterprise is expected on the part of the authority. Integrated Risk management for quality and Supply ChainDr. Thomas's room, Boehringer Ingelheim GmbH integrated risk management at the sample applications product quality and Supply chain reported to the topic. Also it stressed the dramatically changed perception and tolerance of risks in the recent past. On the basis various examples it described the dependence of the risk feeling on systematic and fact-based information, there the expectation of � zero Risiko" not fulfillable always is and � a remainder Risiko" remains. Under these conditions a systematic and fact-based beginning for a risk management is the only meaningful beginning. Which I Q9-Richtlinie offers for this a method standard Dr. global recognized. Room went then in detail on the three parts of a structured Risk management of process as well as on their individual elements. On the basis of examples from enterprise practice it described the possible risks of the expirations of manufacture and processes, in addition, such, which can result from the pharmapolitischen surrounding field. By the example of the approach with flu pandemics in the past and present Dr. Zimmer described in addition differences as well as the crucial advantages with the application of the global method standard I to Q9 straight also in such a case of risk management. The extremely complex connections between planning, sources of error, production, timing and safe supply with medicines in necessary quantity are only controllable with application of these principles. In the end of its remarks it stressed however again that also in this case a residual risk remains. Supplier ManagementDr. Josef K�nzle, Basilea Pharmaceutica internationally Ltd., described the challenges those a Swiss enterprise places itself, which possesses no own manufacturing plant, lets therefore its products at several operating places in Europe manufacture and in Europe would like to drive these out. Supported by the MRA existing within European Union and EWR the predominant part of the supply chain is furnished by processed-out order takers. This begins with the basic materials up to European Union-QP-release and selling. A further characteristic is that Switzerland does not belong to this common domestic market. This represents in particular for on the Qualified person descriptive in annex 16 certification by a adept person and load release a challenge. Three � C" Contracts, Confidence, ControlEin special attention must itself, so Dr. Josef K�nzle, certainly on processed-out order conditions arrange, which are based on three columns: Contracts, confidence and control. An important component of the treaty system should be always a demarcation contractcontract demarcation contract. Outsourcing will strengthen, so the adviser, which will have ever more complex contracts to the consequence. Thus the requirements increase at Compliance in the companies, agreements like the MRA represent only to limited extent a relief. Auditing and supplier qualification - official ErfahrungenDie paging of large parts or the entire supply chain is long ge�bte practice. As legal basis the drug and active substance manufacture regulation (AMWHV) serve, which refer I of the European Union-GMP-manual again to the interpretation of the principles of good manufacture practice for drugs on part. Thus the responsibility remains with the client. It must make sure that the contractor accomplishes according to activity the given instructions and had appropriate permission, as far as this is necessary after �� 13 and 72 AMG. This that the client cannot be relieved by an active examination of his contractors, means contained Dr. Michael Schmidt, directing center drug monitoring Baden-Wuerttemberg. Here in particular the Qualified person is demanded. Audits as part of the active examination who should the audits would drive through and as they should run off? The AMWHV demand for � sufficiently trained Auditoren" Dr. Schmidt gladly to see replaced by a stronger formulation. In each case should be AUDI gates technically qualified and experienced in the manufacture and testing methods concerned, in addition, trusts with audit techniques to be. The advice of the adviser reads to consult for the preparation the current Site master file and to consider reports of preceding audits. After conclusion of the audit a meaningful audit report should be provided, which error and lack and their evaluation list. The report should contain recommendations regarding removal. A summary and pulling conclusions (!) round the report off. Only so this can serve for example the Qualified person as basis with the certification for the load release. Excursion: Third party AuditsAMWHV � 11 permits to fall back it the drug manufacturer under certain conditions to the knowledge third. From the view of the adviser Third so called party audit makes little sense, if they are only formally accomplished, kept general and no clear purchase becomes recognizable the defaults of the client. A quite acceptable instrument are they under the condition,��� * that AUDI gates are technically qualified,��� * a clearly defined order was assigned and the necessary documents for the AUDI gate transparency is,��� * a meaningful audit report is provided inclusively to errors and lack as well as their evaluation,��� * necessary corrective measures to be accomplished.�

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