{"id":6856,"date":"2018-08-17T00:00:00","date_gmt":"2018-08-17T00:00:00","guid":{"rendered":"https:\/\/slcontrols.com\/the-3-stages-of-process-validation-explained\/"},"modified":"2021-10-15T10:05:06","modified_gmt":"2021-10-15T10:05:06","slug":"the-3-stages-of-process-validation-explained","status":"publish","type":"post","link":"https:\/\/www.slcontrols.k8s-stg1-global.sq1.io\/en\/the-3-stages-of-process-validation-explained\/","title":{"rendered":"The 3 Stages of Process Validation Explained"},"content":{"rendered":"

The manufacture of safe and high-quality pharmaceutical products requires good manufacturing processes. This is the goal of Process Validation, i.e. ensuring pharmaceutical products consistently meet quality standards and expectations. The way to achieve this is through the Three Stages of Process Validation.<\/p>\n

The Three Stages of Process Validation is a protocol published in 2011 by the Food and Drug Administration<\/a> (FDA) in the US. Guidance from the European Medicines Agency published more recently promotes stages that are very similar.<\/p>\n

The protocol applies specifically to pharmaceutical manufacturing and involves an approach to validation that covers the entire lifecycle of a product.<\/p>\n

The underlying principle is that you cannot be sure of quality by only testing the finished product. Instead, you need to build in quality \u2013 as well as efficiency and safety \u2013 through each step of the manufacturing process. This is what the Three Stages of Process Validation aims to achieve.<\/p>\n

\"\"<\/p>\n

The Three Stages of Process Validation<\/strong><\/p>\n

The definition of Process Validation from the FDA is as follows:<\/p>\n

\u201cThe collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products.\u201d<\/p>\n

The Three Stages of Process Validation are:<\/p>\n