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THE PHARMA REVIEW (MAY 2010)

Analytical Method Validation

Arindam Basu, R. K. Rishi

Introduction
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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