An analytical procedure is developed to test a defined characteristic of the drug substance or drug product against established acceptance criteria for that characteristic. Early in the development of a new analytical procedure, the choice of analytical instrumentation and methodology should be selected based on the intended purpose and scope of the analytical method. Parameters that may be evaluated during method development are specificity, linearity, limits of detection (LOD) and quantitation limits (LOQ), range, accuracy, and precision.
Analytical method validation is the process of demonstrating that an analytical procedure is suitable for its intended purpose. The methodology and objective of the analytical procedures should be clearly defined and understood before initiating validation studies. This understanding is obtained from scientifically-based method development and optimization studies. Validation data must be generated under an protocol approved by the sponsor following current good manufacturing practices with the description of methodology of each characteristic test and predetermined and justified acceptance criteria, using qualified instrumentation operated under current good manufacturing practices. Protocols for both drug substance and product analytes or mixture of analytes in respective matrices should be developed and executed.