Validation of Analytical Procedures(Q2R1)

VALIDATION OF ANALYTICAL PROCEDURES(Q2R1)

The analytical procedure refers to the way of performing the analysis. Analytical method validation is required to develop new process, new molecules, active ingredients, residues, impurity profiling and component of interest in different matrices. An analytical methodology consists of the techniques, method, procedure and protocol. This methodology includes the required data for a given analytical problem, sensitivity, accuracy, range of analysis and precision to the analyst. It is required for assuring quality, achieving acceptance of products by the international agencies, mandatory requirement purposes for accreditation as per ISO guidelines, mandatory requirement for registration of any pharmaceutical product or pesticide formulation. The main objective is to demonstrate that the procedure is suitable for its intended purpose. The International Conference On Harmonization (ICH) used the forefront of developing the harmonized tripartite guidelines for adoption in the US, Japan and EC issued two guidelines under the titles ‘Text on validation of Analytical procedures (Q2R1)’ 

This document presents a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the EC, Japan and USA. This document does not necessarily seek to cover the testing that may be required for registration in, or export to, other areas of the world. Furthermore, this text presentation serves as a collection of terms, and their definitions, and is not intended to provide direction on how to accomplish validation. These terms and definitions are meant to bridge the differences that often exist between various compendia and regulators of the EC, Japan and USA. 

The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. A tabular summation of the characteristics applicable to identification, control of impurities and assay procedures is included. Other analytical procedures may be considered in future additions to this document.