Method validation pharma environment

• ​Goal of Validation: Analytical validation proves that a testing method works correctly for its intended use.
• ​Why it Matters: Accurate testing ensures that medicines are safe, effective, and of high quality. Because of this, regulators have required validation for many years.
• ​What is the ICH?: The International Conference on Harmonisation (ICH) started in 1990. It is a group where regulators and the pharmaceutical industry talk to each other.
• ​The ICH Goal: Its goal is to create the same approval rules for new medicines across Europe, the United States, and Japan.
• ​ICH Impact: The ICH helped standardize terms, definitions, and basic testing rules. However, because different regions had to agree, the final rules included some compromises.

​Breakdown of Table 1-1 (Validation Requirements)

​The table in the document shows which validation qualities are needed for different types of tests:

• ​Specificity: Needed for all tests (Identity, Impurities, and Assays).
• ​Linearity, Range, and Accuracy: Needed for impurity testing (quantitative) and assays. They are not needed for identity tests or simple impurity limits.
• ​Precision: Needed for quantitative impurity tests and assays.
• ​Detection Limit: Mainly needed for checking the limits of impurities.
• ​Quantitation Limit: Needed specifically for measuring the exact amount of impurities.