Elemental Impurities - ICHQ3D
2. When is it necessary to submit a variation?
A risk analysis regarding elemental impurities of the finished product should be performed, documented and be available on-site. Submission of a variation is only necessary, if the risk analysis shows that:
- the control strategy has to be changed (including changes to already existing controls)
- changes in the manufacturing process are necessary
- materials have to be exchanged or changes in material quality are necessary
Further inquiry note
Page last modified: 24/11/2017