EIGA | Quality Risk Management for Medicinal Gas Cylinder Filling
Use of Quality Risk Management for Preparation of Validation Protocols for Medicinal Gas Cylinder Filling
EIGA Doc. 228/20
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.
Process validation should establish whether all quality attributes and process parameters, which are considered important for ensuring the validated state and acceptable product quality, can be consistently met by the process. The basis by which process parameters and quality attributes were identified as being critical or non-critical should be clearly documented, taking into account the results of any risk assessment activities.
Variations from the typical cylinder filling process configuration exist. Companies shall assess variations and determine if changes from this guidance are necessary.
The approach and activities in this publication are designed to ensure that these gases, which are classified as medicinal products, meet the defined product quality specifications.
The risk management process shall be used to determine the individual steps in the validation protocol(s) to ensure that the installation is:
- set up and calibrated to define procedures;
- capable of producing finished product to the appropriate product quality specifications; and
- compliant with good manufacturing practices (GMP) criteria.
In addition, it shall demonstrate:
- approved operators have been appropriately trained and their competency has been assessed
Table of Contents
2 Scope and purpose
3.1 Publication terminology
3.2 Technical definitions
4 Process description
5 Risk analysis methodology
6 Risk analysis matrix (FMEA)
7 Risk analysis results summary
9 Other references