Accidents and injuries related to work are major occupational health problems in most of the industrialized countries.Traditional approaches to manage workplace safety in mines have mainly focused on job redesign and ...Accidents and injuries related to work are major occupational health problems in most of the industrialized countries.Traditional approaches to manage workplace safety in mines have mainly focused on job redesign and technical aspects of engineering systems.It is being realized that compliance to rules and regulations of mines is a prerequisite;however,it is not sufficient to achieve further reduction in accident and injury rates in mines.Proactive approaches are necessary to further improve the safety standards in mines.Unsafe conditions and practices in mines lead to a number of accidents,which in turn may cause loss and injury to human lives,damages to property,and loss of production.Hazard identification and risk assessment is an important task for the mining industry which needs to consider all the risk factors at workplaces.Applications of risk management approaches in mines are necessary to identify and quantify potential hazards and to suggest effective solutions.In this paper,the following risk estimation techniques were discussed:(i)DGMS(Directorate General of Mines Safety,India)risk rating criterion,and(ii)a matrix based approach.The proposed tools were demonstrated through an application in an opencast coal mine in India.It was inferred that the risk assessment approach can be used as an effective tool to indentify and control hazards in mines.展开更多
基于生理的动力学(physiologically based kinetic,PBK)模型是一种用于模拟化学物质在有机体(如人类和其他动物物种)中的生物过程(吸收、分布、代谢和排泄,简称ADME)和推导体内、外剂量或靶器官剂量的工具。相较于PBK在药物研发的不同...基于生理的动力学(physiologically based kinetic,PBK)模型是一种用于模拟化学物质在有机体(如人类和其他动物物种)中的生物过程(吸收、分布、代谢和排泄,简称ADME)和推导体内、外剂量或靶器官剂量的工具。相较于PBK在药物研发的不同阶段的广泛应用,近几年来PBK在化学物质管理中应用的发展更为迅速。在过去十几年中,化学品安全管理领域的不同国际组织和权威机构相继发布了关于合理构建和使用PBK模型的指导文件。本文主要总结了人类/哺乳动物的PBK模型构建、化学物质健康风险评估中常用的软件和平台,以及PBK模型软件在化学物质管理中的应用和相关案例,简述了基于PBK和体外-体内外推(IVIVE)方法在下一代健康风险评估中的应用潜力,并对PBK在中国化学物质管理应用中需要解决的科学问题进行了讨论,以期为PBK在我国化学物质管理应用提供借鉴。展开更多
The pharmaceutical industry’s increasing adoption of cloud-based technologies has introduced new challenges in computerized systems validation (CSV). This paper explores the evolving landscape of cloud validation in ...The pharmaceutical industry’s increasing adoption of cloud-based technologies has introduced new challenges in computerized systems validation (CSV). This paper explores the evolving landscape of cloud validation in pharmaceutical manufacturing, focusing on ensuring data integrity and regulatory compliance in the digital era. We examine the unique characteristics of cloud-based systems and their implications for traditional validation approaches. A comprehensive review of current regulatory frameworks, including FDA and EMA guidelines, provides context for discussing cloud-specific validation challenges. The paper introduces a risk-based approach to cloud CSV, detailing methodologies for assessing and mitigating risks associated with cloud adoption in pharmaceutical environments. Key considerations for maintaining data integrity in cloud systems are analyzed, particularly when applying ALCOA+ principles in distributed computing environments. The article presents strategies for adapting traditional Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) models to cloud-based systems, highlighting the importance of continuous validation in dynamic cloud environments. The paper also explores emerging trends, including integrating artificial intelligence and edge computing in pharmaceutical manufacturing and their implications for future validation strategies. This research contributes to the evolving body of knowledge on cloud validation in pharmaceuticals by proposing a framework that balances regulatory compliance with the agility offered by cloud technologies. The findings suggest that while cloud adoption presents unique challenges, a well-structured, risk-based approach to validation can ensure the integrity and compliance of cloud-based systems in pharmaceutical manufacturing.展开更多
文摘Accidents and injuries related to work are major occupational health problems in most of the industrialized countries.Traditional approaches to manage workplace safety in mines have mainly focused on job redesign and technical aspects of engineering systems.It is being realized that compliance to rules and regulations of mines is a prerequisite;however,it is not sufficient to achieve further reduction in accident and injury rates in mines.Proactive approaches are necessary to further improve the safety standards in mines.Unsafe conditions and practices in mines lead to a number of accidents,which in turn may cause loss and injury to human lives,damages to property,and loss of production.Hazard identification and risk assessment is an important task for the mining industry which needs to consider all the risk factors at workplaces.Applications of risk management approaches in mines are necessary to identify and quantify potential hazards and to suggest effective solutions.In this paper,the following risk estimation techniques were discussed:(i)DGMS(Directorate General of Mines Safety,India)risk rating criterion,and(ii)a matrix based approach.The proposed tools were demonstrated through an application in an opencast coal mine in India.It was inferred that the risk assessment approach can be used as an effective tool to indentify and control hazards in mines.
文摘基于生理的动力学(physiologically based kinetic,PBK)模型是一种用于模拟化学物质在有机体(如人类和其他动物物种)中的生物过程(吸收、分布、代谢和排泄,简称ADME)和推导体内、外剂量或靶器官剂量的工具。相较于PBK在药物研发的不同阶段的广泛应用,近几年来PBK在化学物质管理中应用的发展更为迅速。在过去十几年中,化学品安全管理领域的不同国际组织和权威机构相继发布了关于合理构建和使用PBK模型的指导文件。本文主要总结了人类/哺乳动物的PBK模型构建、化学物质健康风险评估中常用的软件和平台,以及PBK模型软件在化学物质管理中的应用和相关案例,简述了基于PBK和体外-体内外推(IVIVE)方法在下一代健康风险评估中的应用潜力,并对PBK在中国化学物质管理应用中需要解决的科学问题进行了讨论,以期为PBK在我国化学物质管理应用提供借鉴。
文摘The pharmaceutical industry’s increasing adoption of cloud-based technologies has introduced new challenges in computerized systems validation (CSV). This paper explores the evolving landscape of cloud validation in pharmaceutical manufacturing, focusing on ensuring data integrity and regulatory compliance in the digital era. We examine the unique characteristics of cloud-based systems and their implications for traditional validation approaches. A comprehensive review of current regulatory frameworks, including FDA and EMA guidelines, provides context for discussing cloud-specific validation challenges. The paper introduces a risk-based approach to cloud CSV, detailing methodologies for assessing and mitigating risks associated with cloud adoption in pharmaceutical environments. Key considerations for maintaining data integrity in cloud systems are analyzed, particularly when applying ALCOA+ principles in distributed computing environments. The article presents strategies for adapting traditional Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) models to cloud-based systems, highlighting the importance of continuous validation in dynamic cloud environments. The paper also explores emerging trends, including integrating artificial intelligence and edge computing in pharmaceutical manufacturing and their implications for future validation strategies. This research contributes to the evolving body of knowledge on cloud validation in pharmaceuticals by proposing a framework that balances regulatory compliance with the agility offered by cloud technologies. The findings suggest that while cloud adoption presents unique challenges, a well-structured, risk-based approach to validation can ensure the integrity and compliance of cloud-based systems in pharmaceutical manufacturing.
