Each NDA and ANDA must include the analytical procedures necessary to ensure the identity, strength, quality, purity, and potency of the drug substance and drug product.

Each manufacturers must include a full description of the manufacturing process, including analytical procedures that demonstrate the manufactured product meets prescribed standards of identity, quality, safety, purity, and potency.

Data must be available to establish that the analytical procedures used in testing meet proper standards of accuracy, sensitivity, specificity, and reproducibility and are
suitable for their intended purpose.

Analytical procedures verification or validation data should be submitted in the corresponding sections of the application in the ICH M2 eCTD: Electronic Common Technical Document Specification.

An analytical procedure is developed to test a defined characteristic of the drug substance or drug product against established acceptance criteria for that characteristic.

FWQRC facilitates for the Analytical method development & Validations.


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