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- W3208211049 abstract "Risk or uncertainty are two words frequently used and replaced by one another. In Wherein case of uncertainty, the output is unknown; risky situations give the possible outcomes and the necessary arrangements to deal with it. Thus, risk can actually be quantified, whereas uncertainty cannot be. The study discusses the assessment of the risk involved in different cases that were tried during the procedure. The process of determining the severity and likelihood of adverse effects that may result from exposure to chemical, biological, or physical hazards is known as risk assessment. It is an essential part of the modern advanced pharmaceutical quality. This study provides a general overview of risk assessment which was done before regularization of the process in a pharmaceutical industry (API Plant). It is important to identify the potential causes and risks involved in the manufacturing process before the regularization of the process and suggest the additional controls or CAPA to be taken in case of process identified as a high-risk category. The paper covers the identification of risks that are associated with the process. Thereafter, risk priority number is found out which would help us in comparison of different risks outlined. Subsequently based on the severity, corrective measures are suggested. The study concludes by ensuring that process of continuous quality improvement can be made. Associated riskhave been assessed and controls found to be effective." @default.
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- W3208211049 date "2020-12-25" @default.
- W3208211049 modified "2023-09-26" @default.
- W3208211049 title "Risk Assessment of Product Before the Regularization of the Process" @default.
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