Resultado de búsqueda
General Chapters: <1225> VALIDATION OF COMPENDIAL METHODS. 1225 VALIDATION OF COMPENDIAL METHODS. Test procedures for assessment of the quality levels of pharmaceutical products are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the United States ...
Los procedimientos de prueba para la evaluación de los niveles de calidad de los artículos farmacéuticos están sujetos a diversos requisitos. Según el Artículo 501 de la Ley Federal de Alimentos, Medicamentos y Cosméticos, los ensayos y especificaciones de las monografías de USP–NF constituyen normas legales.
The Current Good Manufacturing Practice regulations [21 CFR 211.194 (a)] require that test methods, which are used for assessing compliance of pharmaceutical articles with established specifications, must meet proper standards of accuracy and reliability. Also, according to these regulations [21 CFR 211.194 (a) (2)], users of analytical methods ...
USP 35 General Information / 〈1225〉 Validation of Compendial Procedures877 ELEMENTS RECOMMENDED FOR THE It is recommended that expired, aged, or spiked samples TRANSFER OF ANAYTICAL PROCEDURES be carefully chosen and evaluated to identify potential problems related to differences in sample preparation equip-
- 143KB
- 6
System suitability test parameters to be established for a particular procedure depend on the type of procedure being evaluated. They are especially important in the case of chromatographic procedures. Submissions to the USP should make note of the requirements under the System Suitability section in the general test chapter Chromatography 621.
USP - 1225 - 1226 - Validación y Verificación de Métodos Analíticos Oficiales | PDF. Scribd es red social de lectura y publicación más importante del mundo.
2 〈1225〉 Validation of Compendial Procedures / General Information USP 36 PRECISION Analytical Performance Characteristics Definition—The precision of an analytical procedure is the degree of agreement among individual test results when the procedure is applied repeatedly to multiple samplings of ACCURACY a homogeneous sample.
