Posts Tagged ‘process validation’

Big Data and Process Analytics for Continued Process Verification

Posted in Life Sciences on Tuesday, April 4th, 2017. No comments yet
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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 biological drugs continues to rapidly grow. In fact, in China alone, there were […]

Continued Process Verification in the Process Validation Lifecycle

Posted in Life Sciences, Operations Management on Thursday, January 22nd, 2015. 5 comments so far
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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 remains in a state of control (the validated state) during commercial manufacture. A system or systems […]

Continuous Process Verification per FDA Process Validation Guidance

Posted in Life Sciences, Operations Management on Thursday, January 19th, 2012. 10 comments so far
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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. Heather shared key elements from this FDA process validation guidance document and how […]