Analytical Method Development and Validation

Abstract

The main objective of the pharmaceutical business is to consistently and economically create goods with the requisite features and quality. The process of finding, creating, and assessing pharmaceutical formulations requires the creation of a methodology. The primary goal of this review article is to examine how the medication development and validation process was carried out, from the beginning of the formulation to the end of the commercial batch. Reliability of the results is essential whenever an analytical method is used to generate results for an array of samples related to medicine. In the pharmaceutical sector, good manufacturing practice (GMP) rules and good laboratory practices (GLP) are adhered to by means of defined validation policies, forms of validation, and validation criteria. Validation is crucial to the efficient operation of the pharmaceutical sector. Validation was done everywhere, from the raw material to the final, stable state. The procedure was appropriately designed, and the validation parameters—specificity, accuracy, quantitation, ruggedness, robustness, and system appropriateness testing—are specified in terms of limit of detection (LOD), limit of quantitation (LOQ), robustness, and ruggedness with reference to specific drug examples. Both the methodology and evaluation of stability make use of all the validation parameters.