Tuesday 9 December 2014

WHO revises non-sterile process validation

The World Health Organization (WHO) is revising its guidance on non-sterile processing validation. The guidance is titled “Revision of the Supplementary Guidelines on Good manufacturing Practice: Non-sterile process validation.”

The process of updating began in 2013. In August 2014 a new draft was circulated for comments. The final version is expected early in 2015.

Process validation data should be generated for all products to demonstrate the adequacy of the manufacturing process. The validation should be carried out in accordance with GMP and data should be held at the manufacturing location whenever possible and be available for inspection.

Central to the guidance is risk assessment, as the guidance states: “risk-based approach in validation is recommended. The use of in-line, online and/or at-line controls and monitoring are recommended to ensure that a process is in a state of control during manufacture.”

The current draft can be viewed here: WHO

Posted by Tim Sandle

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