Unexpected Findings

Unexpected findings

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

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 findings on product safety. This knowledge is crucial to deciding whether to release or recall affected product batches.

A quick response is necessary when such a finding occurs. Production must be 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 quickly assess, process, and help mitigate any unexpected findings.

Check out how SAXOCON can help you here.