Abstract
Visible particulate matter in injectables presents one important question for consideration: ″What are the potential implications to the patient?″; The risks of visible particulate matter to patient safety have been comprehensively reviewed elsewhere. However, the methods utilized to assess and characterize the risk have been explained with various degrees of specificity and supporting rationale. To date, the assessment process lacks the necessary consensus to permit a more standardized and consistent approach to evaluate the potential patient risks. The purpose of this commentary is to provide one paradigm that might be utilized to evaluate the three most relevant factors impacting the risk of injections containing particulate matter: the source of the particle; particle-specific attributes; and characteristics of the intended patient population. Each of these factors are considered with a focus on the more important aspects that might be relevant to imposing untoward risk. The discussion also includes the importance of differentiating the concepts of risk assessment from risk acceptance when establishing criticality levels for product attributes.
- Received January 25, 2018.
- Accepted July 24, 2018.
- Copyright © 2018, Parenteral Drug Association
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