PPT-Forced degradation studies and Analytical method validation

Bujji Kanchi Main Objective works for stability Before performing stability studies a stability indicating method is necessary so that any possible degradants generated during storage conditions such as 5C 25C60RH and 40C75RH can be separated detected and . Bob Seevers. Importance . of . Analytical Methods . in . Development Stability Studies. Without analytical methods it is not possible to know what has happened during stability. Assay. Impurities/Degradation Products. Patricia Hanson, Biological Administrator I. Florida Department of Agriculture and Consumer Services, Food Safety Microbiology Laboratory. Introduction. 17 years in the microbiology section of the Florida Department of Agriculture and Consumer Services, Food Laboratory. Patricia Hanson, Biological Administrator I. Florida Department of Agriculture and Consumer Services, Food Safety Microbiology Laboratory. Introduction. 17 years in the microbiology section of the Florida Department of Agriculture and Consumer Services, Food Laboratory. BY . Dr. . Alka. N . Choudhary. Division of Pharmaceutical Sciences. S.G.R.R.I.T.S., Patel Nagar, Dehradun (UK). “. Validation of an analytical procedure is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for its intended use.”. Anne Warner, Senior Research Advisor, . Bioproduct. Pharmaceutical Development, Eli Lilly & Company. Acknowledgements: . Shanthi Sethuraman. , . Steve . Moran, Eli . Lilly & Company. West . BY . Dr. . Alka. N . Choudhary. Division of Pharmaceutical Sciences. S.G.R.R.I.T.S., Patel Nagar, Dehradun (UK). “. Validation of an analytical procedure is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for its intended use.”. Analytical Method development . Computer system validation, ERP. 1. LIST OF CONTENTS. Process validation. Introduction . Type of validation . Stage of validation. Major phase of validation. SOP. Validation report. products. Meiyu Shen, Lixin Xu. Center for Drug Evaluation and Research, . U.S. . Food and Drug . Administration. This presentation reflects the views of the author and should not be construed to represent FDA’s views or policies. combination of Quality by Design and green analytical . chemistry for analytical . methods in pharmaceutical . sciences. Ludivine . Ferey. , Karen Gaudin. Laboratory. of . Analytical. . Chemistry. – . Chem Bio Pharm I nnovative combination of Quality by Design and green analytical chemistry for analytical methods in pharmaceutical sciences Ludivine Ferey , Karen Gaudin Laboratory of Analytical A simple, precise and accurate stability-indicating isocratic reverse phase ultra-performance liquidchromatographic (RP-UPLC) method was developed for the determination of repaglinide (RPG) in bulk dr Assay Optimization pre- Assay optimization and pre-validation are experiments that determine how a range of matrix and sample elements as well as assay conditions effect assay parameters and assay p Introduction, definition & general principles of calibration, qualification & validation, importance & scope of validation, types of validation, validation master plan, calibration of pH meter, qualification of UV-visible spectrophotometer, General principles of analytical method validation. Roy van . Brummelen. BPharm. , MSc, PhD, . DTech. Institute for Pharmaceutical Services. &. Van . Brummelen. Consultants. royvbc@gmail.com. Method Development & Validation. Specificity. Linearity and range (standard & sample).