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risk assessment approach to planning an API production facility英文资料.pdf

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Online Exclusive from PHARMACEUTICAL ENGINEERING® The Official Magazine of ISPE API Risk Assessment January/February 2012, Vol. 32 No. 1 www.PharmaceuticalE ©Copyright ISPE 2012 This article A Risk Assessment Approach to presents a new risk assessment Planning an API Production Facility table and discusses associated issues, including by Kazuo Tozaki the targets of assessment, criticality, contents of the risk factors, and severity. Targeting of Risk Assessment and may take the form of internal audits by a Corporate Risk and Risk Assessment third-party institution. Risk assessment regard- Targets ing reliability also might become possible as the n general, risk is said to contain a wide contents of “reliability” become clearer. range of types, such as quality risk, safety risk, disaster, and business risk. Thus, it Risk and Uncertainty Iis important to clarify the target before It can be said that the causal relation of the risk conducting the risk assessment. The follow- factors can be described by probability distribu- ing describes the relevant issues that