FDA Guidance on Analytical Method

FDA Guidance on Analytical Method

The FDA Guidance on Analytical Method describes analytical method or procedure thus: “The analytical procedure refers to the way of performing the analysis. It should describe in detail the steps necessary to perform each analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generation of the calibration curve, use of the formulae for the calculation, etc.”

Why is validation necessary?

FDA guidance on analytical method is given to ensure that validation is necessary for an analytical procedure. The purpose is to demonstrate that it is “suitable for its intended purpose”.

ICH and USP validation requirements and parameters

Apart from the FDA; the ICH and USP also have guidances on analytical methods. ICH Guideline for Industry Q2B, Validation of Analytical Procedures: Methodologydescribes the purpose of validation further. It states that “In practice, it is usually possible to design the experimental work so that the appropriatevalidation characteristics can be considered simultaneously to provide a sound, overallknowledge of the capabilities of the analytical procedure, for instance: specificity, linearity,range, accuracy and precision.”

Since these three bodies constitute the triumvirate of regulation; these are the parameters that the USP and ICH take into consideration:

USP:

–        Specificity

–        Linearity and Range

–        Accuracy

–        Precision

–        Limit of Detection

–        Limit of Quantitation

–        Ruggedness

–        Robustness

ICH:

–        Specificity

–        Linearity

–        Range

–        Accuracy

–        Precision

  • Repeatability
  • Intermediate Precision
  • Reproducibility

–        Limit of Detection

–        Limit of Quantitation

 

References:

http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052377.pdf

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002662.pdf

www.slideserve.com/rolf/pharm462

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