viernes, 27 de noviembre de 2009

Microbiological Risk: Do you really need to test raw materials for pathogens?

Many companies are in a survival mode and need to reduce costs and improve efficiencies wherever possible. One area that seems straightforward is testing raw materials for microbial integrity. Why bother? Won’t the manufacturing process kill any microbes that might be residing in the materials? Possibly, yes. But what about an organism that survives, contaminates a product and causes a patient to die?
Is your company prepared to accept the consequences of the FDA, lawyers and families demanding restitution? Is your company ready to thwart the assault from the media? How long can your company survive if it has to recall its products and shut down for months before it can start producing again? Are risky cost reductions too risky? Find out the real implications of saving a few cents and if it’s truly worth the risk.
Obama administration sent recently a bill reinforcing sampling schedule and controls to improve food safety and reduce consumer concerns. Raw materials are receiving tremendous scrutiny from the FDA and other regulatory agencies around the world and have been earmarked as a potential source of uncertainty in the manufacturing of pharmaceuticals, biopharmaceuticals, nutritional supplements and cosmetics.
However a prevailing thought is that the processing steps of manufacturing are severe enough to eradicate most microorganisms that may be present in the raw materials. So why worry about the raw materials? Why test them if the manufacturing process will eliminate them?
Many evidences and reasons why it's in the best interest of a company to test their raw materials: not only from a regulatory perspective but also from a safety and sound business perspective.
Source: Compliance on line

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