“Method Validation Activities in GxP Regulated Environment”
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.
