TY - CHAP A1 - Kung-Tien Liu A2 - Chien-Hsin Chen ED1 - Paulo Pereira ED2 - Sandra Xavier Y1 - 2019-04-10 PY - 2019 T1 - Determination of Impurities in Pharmaceuticals: Why and How? N2 - Quality management (QM) practices are the basis for the successful implementation and maintenance of any QM system. Quality control (QC) is identified as a QM component. Therefore, QM effectiveness is dependent on the QC strategy. QC practice is more or less complex depending on the type of production. The book is focused on new trends and developments in QM and QC in several types of industries from a worldwide perspective. Its content has been organized into two sections and seven chapters written by well-recognized researchers worldwide. Several approaches are debated based on sample traceability, analytical method validation, required parameters, class of exponential regression-type estimators of the population means, determination of impurities, viewpoints, and case studies. BT - Quality Management and Quality Control SP - Ch. 7 UR - https://doi.org/10.5772/intechopen.83849 DO - 10.5772/intechopen.83849 SN - 978-1-78923-878-5 PB - IntechOpen CY - Rijeka Y2 - 2021-09-28 ER -