Tuesday, 8 July 2014

The Top 66 Aseptic Processing Regulations (IVT)

The Institute of Validation Technology (IVT) have posted an informative blog outlining a vast range of regulations and guidances relating to aseptic processing.

Aseptic processing during the manufacturer of pharmaceuticals, medical devices, and combination products is coming under increasing scrutiny over the last few years. From 2004 to 2010, three quarters of drug product recalls involved sterile drug products, and of these sterile product recalls, approximately 80% were due to lack of sterility assurance. The manufacturing of sterile drug products has consistently remained challenging, and industry is always seeking ways to improve and remain compliant with global regulations.

To view the list, go to IVT

Posted by Tim Sandle

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