Transcription of RAW MATERIAL RISK ASSESSMENTS - BioPhorum
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RAW MATERIAL RISK ASSESSMENTS - BioPhorum
1 CONNECT COLLABORATE ACCELERATETMTMRAW MATERIAL RISK ASSESSMENTSA HOLISTIC APPROACH TO RAW MATERIAL RISK ASSESSMENTS THROUGH INDUSTRY COLLABORATIONRaw MATERIAL Risk Assesssments2 BioPhorum Operations Group LtdContents1. Introduction 52. Objective 73. Definitions 84. Scope 105. Goals of raw MATERIAL risk assessment 116. Raw MATERIAL attributes to consider when assessing risk 117. How to differentiate risk recommended factors and examples to consider 148. A tool for quantitative risk assessment Quality functional deployment (QFD) Risk criteria Weighted score Total risk score 259.
Table 2: Raw material risk categories, published in Managing Raw Materials in the QbD Paradigm, Part 1: Understanding Risks article, co-authored by Duncan Low in BioPharm International Volume 23, Issue 11, was a foundational inspiration for the development of the qualification categories.
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