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Unexpected Findings in Production

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Unexpected Findings

Are you responsible for the production of pharmaceutical products such as vaccines? What if you suddenly find something unexpected, like some foreign material or particles in one of the vials you produce?

Sudden unexpected findings of particulate matter in or in contact with drug products are common in pharmaceutical production facilities. Good Manufacturing Practice (GMP) and proper risk management of product quality require identifying the root cause and evaluating the impact of such findings on product safety. This knowledge is crucial to deciding whether to release or recall affected product batches.

A quick response is necessary when a finding occurs. Your production is put on hold while the affected lots are identified, 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 help mitigate any unexpected findings.

read more about how we can help you here.