Doc. 228/20Use of Quality Risk Management for Preparation of Validation Protocols for Medicinal Gas Cylinder Filling

This publication is intended to provide guidance on preparing the protocols for performing validation of systems used for filling medicinal gas cylinders, in compliance with Good Manufacturing Practices.

It provides an overall risk assessment to identify and evaluate potential critical steps in the manufacturing processes for filling medicinal gas cylinders.

This publication provides guidance to EIGA members on how to perform the risk assessment of their medicinal gases manufacturing operations at container filling facilities.