Incorporating Industrial Forensics into a Quality by Design Approach for Foreign Particulate Matter Characterization

Foreign particulate matter (FPM) can affect product efficacy but more importantly product safety particularly within certain life science industries.  The importance of characterizing FPM is evidenced by numerous warning letters and consent decrees recently issued by the FDA for a lack of resolution to this issue. Traditional methods for detecting FPM focus on the size and quantity of these materials rather than identity and are typically employed at the end of production on final products. A more efficient and proactive approach is needed to facilitate FPM investigations in a quality by design (QbD) environment.

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