The quality system of any modern pharmaceutical company is the pharmaceutical quality system(PQS),which extends the GMP standards to all stages of the medicinal productslife cycle,from pharmaceutical development to it...The quality system of any modern pharmaceutical company is the pharmaceutical quality system(PQS),which extends the GMP standards to all stages of the medicinal productslife cycle,from pharmaceutical development to its withdrawal from production.The principal difference between PQS and GxP rules from other quality systems is that the medicinal product,its safety and efficacy is put at the forefront.At the same time,PQS implies a process approach to all components that should be aimed at achieving the main goal—ensuring and guaranteeing the quality of the medicinal product for the end user(patient)—and should be based on the quality risk management system.An integral part of PQS,as well as the GxP rules adopted in the European Union and PIC/S,is a process for self-inspections and/or quality audits,which regularly appraises the effectiveness and applicability of the PQS.This publication is dedicated to the definition of self-inspections(internal audits)as one of the PQS’s processes.The article defines the main standard stages and develops a model of a risk-based approach to the self-inspections’planning in relation to processes of the pharmaceutical quality system.展开更多
This study employed an innovative meth- odological framework that combines geomatics and conventional survey methods to monitor changes in forest conditions and examine their associations with local forest governance ...This study employed an innovative meth- odological framework that combines geomatics and conventional survey methods to monitor changes in forest conditions and examine their associations with local forest governance parameters in a mountain watershed covering 153.3 km2 in the middle moun- tains of Nepal. The study involved two spatial scales and analytical steps. First, geomatics techniques were used to map and detect changes in major land cover types in the watershed between 1976 and 2000 and to analyze relationships between forest cover changes and governance arrangements. This was followed by micro-level analysis of the relationships between the biological conditions of selected forests within the watershed and their governance arrangements, using conventional survey methods and analytical tools. The findings show that forest cover in the watershed in- creased by about 15 per cent during the period. The rate of increase in forest cover was highest in areas under a semi-government type of governance ar- rangement, while the community forests were gener- ally better in terms of current biological conditions compared to the semi-government forests. This in- consistency between the findings from the two analy- ses does not allow us to draw any firm conclusions regarding the role of property rights in determining forest condition, but it indicates that the outcomes of local forest management initiatives may be more de-pendent on local institutional arrangements regulat- ing forest use and maintenance of forest resources than on the type of property rights arrangements. The findings also provide evidence of the methodological suitability of the research approach adopted, which may be useful for addressing many other research questions related to forestry and natural resources management, particularly those involving multiple spatial scales.展开更多
Objective To summarize the clinical features of intracranial aneurysms of posterior cerebral artery (PCA) ,and the surgical approaches and operative skills to treat them . Methods The aneurysms arose from the P1 segme...Objective To summarize the clinical features of intracranial aneurysms of posterior cerebral artery (PCA) ,and the surgical approaches and operative skills to treat them . Methods The aneurysms arose from the P1 segment in 3 patients,the P2 segment in 5 patients and the P3 segment in 2 patients.展开更多
文摘The quality system of any modern pharmaceutical company is the pharmaceutical quality system(PQS),which extends the GMP standards to all stages of the medicinal productslife cycle,from pharmaceutical development to its withdrawal from production.The principal difference between PQS and GxP rules from other quality systems is that the medicinal product,its safety and efficacy is put at the forefront.At the same time,PQS implies a process approach to all components that should be aimed at achieving the main goal—ensuring and guaranteeing the quality of the medicinal product for the end user(patient)—and should be based on the quality risk management system.An integral part of PQS,as well as the GxP rules adopted in the European Union and PIC/S,is a process for self-inspections and/or quality audits,which regularly appraises the effectiveness and applicability of the PQS.This publication is dedicated to the definition of self-inspections(internal audits)as one of the PQS’s processes.The article defines the main standard stages and develops a model of a risk-based approach to the self-inspections’planning in relation to processes of the pharmaceutical quality system.
文摘This study employed an innovative meth- odological framework that combines geomatics and conventional survey methods to monitor changes in forest conditions and examine their associations with local forest governance parameters in a mountain watershed covering 153.3 km2 in the middle moun- tains of Nepal. The study involved two spatial scales and analytical steps. First, geomatics techniques were used to map and detect changes in major land cover types in the watershed between 1976 and 2000 and to analyze relationships between forest cover changes and governance arrangements. This was followed by micro-level analysis of the relationships between the biological conditions of selected forests within the watershed and their governance arrangements, using conventional survey methods and analytical tools. The findings show that forest cover in the watershed in- creased by about 15 per cent during the period. The rate of increase in forest cover was highest in areas under a semi-government type of governance ar- rangement, while the community forests were gener- ally better in terms of current biological conditions compared to the semi-government forests. This in- consistency between the findings from the two analy- ses does not allow us to draw any firm conclusions regarding the role of property rights in determining forest condition, but it indicates that the outcomes of local forest management initiatives may be more de-pendent on local institutional arrangements regulat- ing forest use and maintenance of forest resources than on the type of property rights arrangements. The findings also provide evidence of the methodological suitability of the research approach adopted, which may be useful for addressing many other research questions related to forestry and natural resources management, particularly those involving multiple spatial scales.
文摘Objective To summarize the clinical features of intracranial aneurysms of posterior cerebral artery (PCA) ,and the surgical approaches and operative skills to treat them . Methods The aneurysms arose from the P1 segment in 3 patients,the P2 segment in 5 patients and the P3 segment in 2 patients.
