Real time release testing - Scientific guideline

This guideline applies to human and veterinary medicines.

This document outlines the requirements for applications that propose real time release testing for active substances, intermediates and finished products. It addresses the need for interaction between quality assessors and good manufacturing practice inspectors in the approval process. This guideline is a revision of the guideline on parametric release and does not introduce new requirements.

Keywords: Parametric release, batch release, sterilisation, process analytical technology, quality by design, real time release testing

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