Process validation for finished products – information and data to be provided in regulatory submissions - Scientific guideline

This guideline applies to human and veterinary medicines.

This document provides guidance on the process validation information and data to be provided in regulatory submissions for the finished dosage forms of chemical medicinal products for human and veterinary use. The general principles also apply to active substances. The principles described are also applicable to biological medicinal products, but these should be considered on a case by case basis.

Keywords: Process validation, continuous process verification, on-going process verification, critical process parameter, critical quality attribute, lifecycle, change control