ISSN: 2574-7797
Authors: Ankit J* and Vijayraj S
The pharmaceutical industry is dedicated to consistently producing high-quality products at an optimal cost, necessitating the development of robust methodologies across various stages from formulation to commercialization. This review article delves into the critical aspects of designing and validating processes integral to pharmaceutical drug development. Emphasizing the importance of reliable analytical techniques, the review underscores their role in quality assessment of pharmaceutical samples. A cornerstone of pharmaceutical manufacturing is adherence to Good Manufacturing Practice (GMP) regulations, which mandates comprehensive documentation and validation of processes. From raw material procurement to final batch production, validation ensures adherence to quality standards throughout the manufacturing chain. The article meticulously examines the creation and validation of analytical methods, focusing on parameters including accuracy, specificity, and precision, limit of detection (LOD), limit of quantitation (LOQ), ruggedness, robustness, and system suitability testing. These validation parameters are instrumental in routine and stability analyses, guaranteeing the reliability and quality of pharmaceutical products. By elucidating the intricate nuances of validation methodologies, this review contributes to the efficient operation of pharmaceutical companies and the continual advancement of drug development practices.
Keywords: Analytical Chemistry; Validation Methodologies; Peak; Mobile Phase; Stationary Phase; Accuracy; Precision; Analyte
