Do you need to do risk assessment before doing validation? Can we skip some validation parameters (with low risk) in method verification?
I would always make a risk assessment and identify the method type (impurity, quantitative, etc.) to ensure the relevant parameters are computed.
Join Dr. Pierre Lebrun (Cencora – PharmaLex) to learn more about Practical Examples and Regulatory Expectations for the Validation of Biotechnological Analytical Methods – Linearity Testing, Total Error Approach.
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