What is Process validation as per ISO 13485 Medical Devices Quality Management System Standard?

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In This session we have discussed about Process validation as per ISO 13485 Medical Devices Quality Management System Standard. We have discussed about what is Process validation as per ISO 13485, Stages of Process Validation, Types of Process Validation.

“Process validation as per ISO 13485 Medical Devices Quality Management System Standard.”

Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products. Process validation involves a series of activities taking place over the lifecycle of the product and process.

The Three Stages of Process Validation is a protocol published in 2011 by the Food and Drug Administration (FDA) in the US. Guidance from the European Medicines Agency published more recently promotes stages that are very similar. The protocol applies specifically to pharmaceutical manufacturing and involves an approach to validation that covers the entire lifecycle of a product.

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