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Validation of Analytical Procedures: Part 1

Types of Analytical Procedures

Category I: Identification Test 

To ensure the identity of an analyte in a sample.

  • Comparison of a property of the sample to that of a reference standard.
  • To differentiate compounds of closely related structures which are expected to be present.

Category II: Impurities Test (Quantitative)

Quantitative determination of impurities.

  • Determination of impurities in a drug substance or degradation compounds in drug product.

Category II: Impurities Test (Limit)

  • Limit control of impurities.
  • To accurately reflect the purity characteristics of a sample.
  • Related substances, residual solvents content, heavy metals, etc.

Assay Test (Quantitative) 

To measure the analyte present in a sample.

  • Quantitative tests of the active moeity, major components of the drug substance (DS)/drug product (DP).
  • Potency assay, content uniformity.
  • Dissolution: determination of the performance characteristic (drug release) of the product.

Once the analytics method type/category is assessed, determine which validation parameters should be evaluated. 

You may be interested in the following article:

A Comparative Framework Between New Product and Legacy Product Process Validation

This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.