Explain the hazard and risk analysis in pharmaceutical products.
Answers
Risk management principles are utilized effectively in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance and by agencies regulating these industries. The basic quality risk management process should include the level of effort, formality and documentation of quality risk management process which should commensurate with level of risk. The risk assessment process should be carried out by analyzing, identifying and evaluating the risk and the quality risk management plans should be reviewed after their follow up. The risk management methodology can be implemented which provides documented, transparent and reproducible methods to accomplish steps of quality risk management process based on current knowledge about assessing the probability, severity, and sometimes, detachability of the risk. The methodology also includes the study of hazards and their operability and analytical tools. With the risk management tools the pharmaceutical industry and regulators can manage and assess risk. The degree of rigor and formality of quality risk management should reflect available knowledge and be commensurate with the complexity and/or criticality of the issue to be addressed. Primary Hazard Analysis might be useful while analyzing existing systems or prioritizing hazards where circumstances prevent a more extensive technique from being used . However, effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance of a company’s ability to deal with potential risks, and might affect the extent and level of direct regulatory oversight.
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