“Method Validation Activities in GxP Regulated Environment”

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DOI: 10.21522/TIJCR.2014.05.01.Art007

Authors : Diana Karagiozova

Abstract:

The focus of this research is to evaluate the method validation processes in ELISA (enzyme-linked Immunosorbent assay), particularly in the development of drugs and biologics and subsequent method validations following strictly regulated rules in GxP controlled environment.

In an effort to bolster the existing formal system of controls at pharmaceutical companies through the CGMP regulations, the Food and Drug Administration (2011) has established general principles and practices for the validation process. These general principles and practices are suitable elements that pharmaceutical companies should use in process validation for the manufacture of animal and human biological and drug products, including the active pharmaceutical ingredients (APIs).

Keywords: ELISA, validation, GxP, FDA, critical reagents, regulations.

References:

The focus of this research is to evaluate the method validation processes in ELISA (enzyme-linked Immunosorbent assay), particularly in the development of drugs and biologics and subsequent method validations following strictly regulated rules in GxP controlled environment.

In an effort to bolster the existing formal system of controls at pharmaceutical companies through the CGMP regulations, the Food and Drug Administration (2011) has established general principles and practices for the validation process. These general principles and practices are suitable elements that pharmaceutical companies should use in process validation for the manufacture of animal and human biological and drug products, including the active pharmaceutical ingredients (APIs).

Keywords: ELISA, validation, GxP, FDA, critical reagents, regulations.