• specific intended use = analytical requirement • objective evidence = experimental data (method performance parameters) ... – verification of the performance of previously validated methods ... – make deliberate changes to method parameters – observe effect on results • Control key parameters During the method development, the critical attributes of the method are determined with a focus on an analytical target profile. Project scope: Identify the test methods and which prod- has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity. 1 Department of Pharmaceutical Analysis, Dr. C.S.N Institute of Pharmacy, Industrial Estate Area, Bhimavarm, India. 3.2 Pharmacopoeial methods used for determination of content or impurities in pharmaceutical products should also have been ... and should show the reliability of an analysis when deliberate variations are made in method parameters. The limit should be subsequently validated by the analysis of a suitable number of samples known to be near or prepared at the quantitation limit. The method should give a specific result that may not be affected by external matters. Robustness should be considered during the development phase, and should show the reliability of an analysis when deliberate variations are made in method parameters. Reliable analytical methods (validation) is a fundamental GLP requirement. Parameters that are evaluated during method development are specificity, linearity, limits of detection (LOD) and limits of quantitation (LOQ), range of accuracy, and precision. An Analytical Procedure is the most important key in Analytical Method Validation.The analytical procedure defines characteristics of Drug Product or Drug Substance also gives acceptance criteria for the same. 9. However, the given instructions in these general texts leave room for interpretation on the scope of a method verification. there are two Types of Analytical Procedures first is Specifications and standard test method in Pharmacopoeias or Pharmacopoeial methods and second one Non-Pharmacopoeial method or method which is developed In-house and approved by the National Regulatory Authority. Impurities (Quantitation):- Approaches other than those listed below may be acceptable. The method should give a specific result that may not be affected by external matters. 6.1.2 Precision is the degree of agreement among individual results. reference material); Lecture 5: Transfer of Analytical Methods and Procedures. Several approaches for determining the detection limit are possible, depending on whether the procedure is a non-instrumental or instrumental. Analytical Method Validation. Validation and verification of analytical methods 2.1 Introduction: role of validation within quality assurance and good laboratory practices Methods used in an analytical chemistry laboratory must be evaluated and tested to ensure that they produce valid results suitable for their intended purpose, i.e. Suitable identification tests should be able to discriminate between compounds of closely related structures which are likely to be present. This test is mainly to check the recovery of API with Placebo. An analytical method being transferred should not refer to or rely on any internal documentation or SOPs that are not provided to the RU. Editable Pharmaceutical Documents in MS-Word Format. The slope S may be estimated from the calibration curve of the analyte. Accuracy should be established across the specified range of the analytical procedure. The slope S may be estimated from the calibration curve of the analyte. 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