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GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
Analytical method validation protocols
Method validation provides documented evidence that a given test method can
and will consistently generate reliable results.
Validation of an analytical method is the process of formally establishing that
the method will meet the intended analytical application, e.g. to identify a specific
impurity.
Protocols are used as planning tools to describe the different tests and the
acceptable results applied to demonstrate the validity of the method. Different
methods will have different validation criteria: standard methods must be
demonstrated as "fit for purpose" in the laboratory; adapted and non-standard
methods must be validated.
Performance parameters required for assay validation
ICH guidance and pharmacopoeial monographs recommend that a number of
test method performance parameters be evaluated during analytical method
validation. The performance parameters evaluated depend on the use of the
method. For example, tests for impurities require either Limit of Detection (LOD)
or Limit of Quantitation (LOQ).
(adopted from USP 25 <1225> and ICH Q2(Rl))
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