Real time release testing

This guideline applies to human and veterinary medicines.

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

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