Why Analytical Methods Need To Be Validated?

1.	Why Analytical Methods Need To Be Validated?
Answer» The Food and Drug Administration (FDA), European and other regulatory authorities have requirements and expectations regarding the performance and documentation of an analytical method validation. Method validations are required when a new method is developed, an existing method is significantly modified (optimized) or an existing, validated method is applied to a different sample matrix. These METHODS may include HPLC, GC, GC/MS, UV-Visible, FTIR, titration, etc. ADDITIONALLY, many wet chemistry (non-instrumental) methods require some level of verification or validation. Executing validation ACTIVITIES is not a one-step process. There must be assurance that "the accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm are established and documented." (CFR Title 21-Part 211). The FDA and other regulatory authorities have CITED organizations for not providing assurance that their test methods have been appropriately validated or verified. Many firms use USP methodology for routine analyses but fail to verify that the methods are "suitable for their intended use." A few examples of key regulatory findings include: Company A - Failure to have laboratory controls which establish scientifically sound and appropriate specifications, standards, and test procedures to assure product identity, strength, purity, and quality.

Answer»

The Food and Drug Administration (FDA), European and other regulatory authorities have requirements and expectations regarding the performance and documentation of an analytical method validation.
Method validations are required when a new method is developed, an existing method is significantly modified (optimized) or an existing, validated method is applied to a different sample matrix. These METHODS may include HPLC, GC, GC/MS, UV-Visible, FTIR, titration, etc. ADDITIONALLY, many wet chemistry (non-instrumental) methods require some level of verification or validation.
Executing validation ACTIVITIES is not a one-step process.
There must be assurance that "the accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm are established and documented." (CFR Title 21-Part 211).
The FDA and other regulatory authorities have CITED organizations for not providing assurance that their test methods have been appropriately validated or verified. Many firms use USP methodology for routine analyses but fail to verify that the methods are "suitable for their intended use." A few examples of key regulatory findings include:
Company A - Failure to have laboratory controls which establish scientifically sound and appropriate specifications, standards, and test procedures to assure product identity, strength, purity, and quality.

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