Generally, any method used to produce data in support of regulatory (e.g., FDA, EMA) filings or the manufacture of PHARMACEUTICALS for human use must be VALIDATED. This includes bioanalytical methods of analysis for bioavailability (BA), bioequivalence (BE), pharmacokinetic (PK), toxic kinetic (TK), and clinical studies, as well as methods used for analytical testing of manufactured drug substances and products.

According to ICH Guidelines, the following four types of methods require validation:

• Identification tests
• Quantitative tests for impurities content
• Limit tests for the control of impurities
• Quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in the drug product.

In addition, ICH Guidelines define these four types of methods:

• “Identification tests are intended to ensure the identity of an analyze in a sample. This is normally achieved by COMPARISON of a property of the sample (e.g., spectrum, chromatographic behavior, chemical reactivity, ETC.) to that of a reference standard. Testing for impurities can be either a quantitative test or a limit test for the impurity in a sample. Either test is intended to accurately reflect the purity characteristics of the sample. Different validation characteristics are required for a quantitative test than for a limit test.
• Assay procedures are intended to measure the analyze present in a given sample. In the context of this document, the assay represents a quantitative measurement of the major component(s) in the drug substance. For the drug product, similar validation characteristics also apply when assaying for the active or other selected component(s). The same validation characteristics may also apply to assays associated with other analytical procedures (e.g., DISSOLUTION).”
• From ICH Harmonized Tripartite Guideline “Validation of Analytical Procedures: Text and Methodology” Q2 (R1).

Generally, any method used to produce data in support of regulatory (e.g., FDA, EMA) filings or the manufacture of pharmaceuticals for human use must be validated. This includes bioanalytical methods of analysis for bioavailability (BA), bioequivalence (BE), pharmacokinetic (PK), toxic kinetic (TK), and clinical studies, as well as methods used for analytical testing of manufactured drug substances and products.

According to ICH Guidelines, the following four types of methods require validation:

In addition, ICH Guidelines define these four types of methods: