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Unexpected Findings in Production

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Medical Device Manufacturing

Pharmaceutical and medical device manufacturers and materials suppliers must ensure their products are not shedding harmful particles. Unexpected particulate findings during production are a risk that all manufacturers face.

Sudden, unexpected findings of particulate matter in or in contact with products can occur in production facilities. Good Manufacturing Practice (GMP) and proper risk management of product quality require identifying root causes and evaluating the impact of such findings on biosafety. This knowledge is crucial to deciding whether to release or recall affected products.

A quick response is necessary when a finding occurs. Your production can be put on hold while identifying the affected lots, and then the hard work of figuring out the type and extent of the problem begins.

SAXOCON has the in-house expertise and experience to help you quickly assess, process, and mitigate any unexpected findings.

Read more about how we can help you here.