Abstract:

The Food and Drug Administration (FDA) is a federal agency of the United States that is responsible for protecting the health of the public by ensuring the security, efficacy, and safety of both the veterinary and human drugs. The agency is also responsible for ensuring the safety of the food supply, radioactive materials, and cosmetics in the United States. The FDA has a statutory duty of ensuring that manufacturers of various products, including pharmaceuticals, comply with their respective established Good Manufacturer Practice (GMP).

ELISA (enzyme-linked Immunosorbent analysis) is an important bioanalytical assay format that pharmaceutical companies particularly use to validate in order to achieve a robust method suitable for the purpose of development of drugs and biologics in FDA regulated environment.

The analytical laboratories carrying out all toxicology or pharmacology as well as other pre-clinical studies for the purposes of making regulatory submissions are expected to comply with FDA’s Good Laboratory Practices (GLPs) and sound quality assurance principles throughout the validation of appropriate ELISA methods and/or testing process. As long as pharmaceutical companies evaluate analytical methods before and during regular use, they are not under any statutory obligation to comply with the FDA guidelines on method validation, including bioanalytical methods such as ELISA methods.

Keywords: FDA, GxP, Impurity ELISA, sandwich ELISA, validation. Basic Principles and Applied GxP Regulations for ELISA Analytical Method Validation of Drugs and Biologics in FDA Driven Environment.

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