Mistakes often unnoticed after method validation work is completed. These include as follows:
No matter how rigorously performed, method validation alone is not enough. Everything has to be well and fully documented.
Insufficient validation report which does not include ALL observations, incidence, justification, amendment and deviations.
Failure to incorporate major observations from forced degradation and validation studies in the method.
Not including Detection (LOD) and Quantification (LOQ) limits in the validated analytical method.
Unable to demonstrate analytical method transfer to receiving laboratory (QC lab) in timely and correct manner.
Failure to peer review sufficiently the Method validation and approved by QA.
Failure obtain feedback from the receiving laboratory (QC lab) and incorporate these comments and observations regarding analytical method transfer.
Failure to conduct an annual review of the method, data trending, related to the method and analyst feedback. (updated on 8.10.2020)