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As you know, pharmaceutical industry is a regulated industry and makes products that directly affect the health of the patient. Because all these pharmaceutical products are administered by the patient, then the safety of the products becomes very important. So now the question is how can we do regular watch, so the answer is a regular management review meeting. “Better the Management Review, Better the performance of organization will be.” Regulatory view on Management review ICHQ10 Management Review (2.6) (a) Senior management should be responsible for pharmaceutical quality system go
What should be the Risk Management Approach, We all recognize that risk management could be a very good tool to avoid any major failure or disaster with in the future if we actually justice with this tool, which means if we really follow it seriously these days then it’ll save us with in the future. What is the objective of Risk Management Risk management is a process to identify, evaluate, control, communicate, mitigate any kind of threat/hazard up to the acceptance limit and further continous review. Quality Risk Management as per ICH Q9 “Quality risk management is a systematic process for t
The biggest concern in this Regulatory Challenging Environment is to apply risk-based thinking for implementing, deploying and maintaining a quality management system with limited resource There is a significant concern of every pharmaceutical professional who is responsible to ensure the consistent quality of products and who are responsible for deploying & implementing the quality management system (QMS) throughout the product life-cycle. Risk Management concept is not new, this tool is used for a long time in the pharmaceutical industries but now it is used differently to identify the risk
As on 29-Nov-2018
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