Unexpected Findings

Unexpected findings

Are you responsible for the production of pharmaceutical products, such as vaccines? What if you suddenly find something unexpected, 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 can be crucial for deciding whether to release or recall affected product batches.

A quick response is necessary when such a finding occurs. You must put production on hold and identify 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 assess, process, and help mitigate any unexpected findings quickly.

Check out how SAXOCON can help you