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New FDA Guidance refers to ICH Guideline Q2(R1) as primary reference

The new FDA Guidance “Analytical Procedures and Methods Validation for Drugs and Biologics” includes several recommendations on reference material usage. Following on from our previous blog post, we have pulled out a second recommendation for you:

For validation parameters such as specificity and accuracy the new FDA Guidance refers to ICH Q2(R1)* as primary reference: “ICH Q2(R1) is considered the primary reference for recommendations and definitions on validation characteristics for analytical procedures.”

ICH Q2(R1) in turn recommends to spike samples with impurity materials in order to show the specificity of both assay and impurity tests. They also suggest spiking for validation of accuracy for assay and quantitative impurity tests.

LGC offers over 5,000 pharmaceutical impurities from all relevant industry suppliers. Especially LGC manufactured impurities are highly characterized materials suitable for method development, validation in quality control, stability testing and for spiking purposes in the validation of specificity and accuracy.

*ICH harmonized tripartite guideline: Validation of analytical procedures: text and methodology Q2(R1), November 2005.

For further take-aways read also this blog post .

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