Analytical procedure is nothing but the way of
performing particular analysis. It is written in detail
in a stepwise manner. Analytical method validation is
done to ensure compliance with quality and safety
standards of a pharmaceutical product. Analytical Method
validation is a process to prove that an analytical
method is suitable for the intended purpose. In case of
analysis of drugs, pharmacopoeias e.g. Indian
Pharmacopoeia (I.P.), British Pharmacopoeia (B.P.),
United States Pharmacopoeia (U.S.P) etc. describe
official test procedures for many marketed drug
products. They are validated methods. Pharmacopoeial
methods are standardized by conducting several
scientific studies and subjecting those results to
statistical interpretations. Pharmacopoeial method
validation is of paramount importance for newly
discovered drug molecules.
Analytical method validation is of paramount importance
for a newly discovered molecule. It is also an ongoing
activity to improvise the existing analytical methods.
The goal of analytical method validation is to ensure
confidence in the analytical data throughout the life
cycle of a particular pharmaceutical product. It is an
exhaustive activity that requires use of chemistry,
analytical procedures as well as proper documentation.
It is required at the stage of regulatory approval of
new drugs. As a part of regulatory submission, these
details are required to be submitted in prescribed
formats e.g. CTD format to the licensing authority.
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