A biological drug is defined as a: …substance that is made from a living organism or its products and is used in the prevention, diagnosis, or treatment of cancer and other diseases. Biological drugs include antibodies, interleukins, and vaccines. The market for...
In 2011, the U.S. Food and Drug Administration (FDA) issued a Guidance for Industry – Process Validation: General Principles and Practices. It highlighted a third validation stage goal of continued process verification (CPV) for: …continual assurance that the process...
It was just about a year ago that the U.S. Food and Drug Administration published their Guidance for Industry - Process Validation: General Principles and Practices. I caught up with Emerson's Heather Schwalje, a senior consultant on the Life Sciences industry team....
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