Yes, that's perfectly true. The initial validation should be regarded as a starting point, i.e. the formal approval of the analytical procedure for practical application. During the practical application, data should be gathered (e.g. RSDs, replicates ranges, control chart data) to verify that the performance is maintained (ongoing monitoring).

Join Dr. Joachim Ermer (Ermer Quality Consulting) to learn more about Practical Examples and Regulatory Expectations for the Validation of Biotechnological Analytical Methods – Linearity Testing, Total Error Approach.

Watch the On-Demand presentation now: https://bio-qc.com/practical-examples-and-regulatory-expectations-for-the-validation-of-biotechnological-analytical-methods-linearity-testing-total-error-approach/  

Plus, don’t miss his expert insights during the panel discussion on Addressing Challenges in Analytical Validation: Understanding ICH Q2(R2) and Integration with ICH Q14.