-
Risk Management in the Pharmaceutical Industry
Schriftenreihe: GMP REPORT
Ein funktionierendes Risiko-Bewertungssystem ist ein wichtiger Faktor der Arzneimittelsicherheit. Das gilt für Industrie und Zulassungsbehörden sowie Inspektorate gleichermaßen. Risikobewertung ist eine gesetzliche Forderung. Bei der Herstellung von Arzneimitteln sorgen Qualitätssicherungssysteme und eine periodische Qualitätsbewertung dafür, daß jedes Produkt und jeder Prozeß kontinuierlich bewertet werden.Die aktuelle Ausgabe Risikomanagement in der Pharmaindustrie beschreibt praxisnah Grundlagen und Umsetzungsmöglichkeiten des Risikomanagements im pharmazeutischen Umfeld. Die entsprechenden regulatorischen Vorgaben werden erläutert, und zahlreiche Fallbeispiele zeigen, wie sich die Vorgaben in der betrieblichen Praxis erfolgreich umsetzen lassen. Darüber hinaus werden die Möglichkeiten des IT-gestützten Risikomanagements beschrieben sowie eine Reihe von Risikomanagement-Tools vorgestellt und bewertet.
Namhafte Autoren decken alle wesentlichen Risikomanagement-relevanten Aspekte tief greifend und zugleich praxisnah ab.
Kapitel 1: Regulatory Requirements
.... Regulatory Requirements ą Risk Management from the Point of View of a Competent Authority Risk ...
.... Risk Management from the Point of View of a Competent Authority Rudolf Völler GMP Inspectorate, Regierungspräsidium, Darmstadt (Germany) Summary A working risk evaluation system is a key element of ...
.... is discussed on international level and is laid down in GMP guidelines which have to be observed by all involved parties. In German QA documents for competent authorities these ...
.... all involved parties. In German QA documents for competent authorities these principles were transferred into SOPs for inspectors. Pharmacovigilance and pharmaceutical-technical procedures are subject to a risk assessment system. ...
.... and periodic quality reviews ensure that each product and each process is assessed continuously. Inspectorates are subjected to inspection planning and the conduction of inspections according to a risk ...Insgesamt 114 Fundstellen in 80 Textabschnitten
Kapitel 2: Overview on Risk Management Tools
.... on Risk Management Tools ą Risk Management Tools Risk Management Tools Denis Nienhüser RRR − Reduced Rest Risk, ...
.... The Q9 ICH Guideline demands a lot of in-house Risk Management. It presents different tools which help to fulfil these requirements. However none of the listed methods can be ...
.... used universally. Therefore they must be adjusted in most cases. The following article helps to identify the advantages and disadvantages of the recommended methods. Key words ICH-Q9 · Methods ...
.... implementation of a Risk Management system [1]. The purpose of the ICH Q9 is to ensure that the responsible persons in a pharmaceutical or medical-technical business always work at ...
.... examination of all quality-relevant processes of a business (annotation by author: and corresponds thus to the principle of voluntary QMS). The ICH Q9 determines the components and process of ...Insgesamt 204 Fundstellen in 134 Textabschnitten
Kapitel 3: Case Studies
.... Studies ą A Risk Based Approach to Establishing a cGMP Audit Schedule ą Risk Management ...
.... Risk Based Approach to Establishing a cGMP Audit Schedule ą Risk Management with Regard to Starting Materials ą Use of Risk Assessment Tables during Development Stage ą The Use ...
.... Qualification of Analytic Instruments ą Risk Assessment in Pharmaceutical Engineering A Risk Based Approach to Establishing a cGMP Audit Schedule Richard M. Bonner Frodsham, Cheshire (United Kingdom) Summary This ...
.... Bonner Frodsham, Cheshire (United Kingdom) Summary This article describes what is required in order to produce a risk-based cGMP audit schedule which is then used to compare the risks ...
.... with the different types of units and prioritise them. It requires each auditable unit to be scored on a scale of 1 to 5 against six pre-determined criteria. The ...Insgesamt 1023 Fundstellen in 635 Textabschnitten
Kapitel 4: Computer-assisted Risk Management
.... Risk Management required by the authorities can be carried out by electronic data processing tools. But till now the available software solutions aren’t developed well enough, so that a ...
.... solutions aren’t developed well enough, so that a high expenditure is required in order to compensate the existing deficits. Key words Electronic data processing · Risk management · Software, ...
.... ask for a risk management. The ICH-Guideline Q9 [1] explains this risk management and shows some risk methods. These meet the official requirements only partially however. Accordingly the representatives ...
.... methods. The complaints regard the incompleteness of the risk analysis, the heterogeneity with respect to the extent and the detail depth of the risk analysis. In the risk evaluation ...
.... risk assessment incomprehensible assessments and insufficient improvements are complained. Increasingly, EDP (Electronic Data Processing) tools compete with the data sheet which were used until now for the risk management. ...Insgesamt 116 Fundstellen in 76 Textabschnitten
