A Succinct Assessment of the Development, Validation, and Method Verification of Analytical Methods for Natural and Synthetic Therapeutic Molecules
Author(s): Sandip Kumar Dey, Sumanta Mondal*, K.N. Killari, Samson Israel, G.V. Sampath Kumar and Abu Mohiuddin
Abstract
Analytical method development, validation, and verification are the continuous and interdependent tasks associated with the research and development, quality control, and quality assurance departments. The primary purpose of the analytical method development and validation is to prove that the proposed analytical method is accurate, specific, precise, and robust in the pharmaceutical industry for analysis of a drug moiety as the drug must be manufactured to the highest quality levels. Analytical methodology development has become an essential activity of study. Recent development in analytical methods has resulted from the advancement of analytical instruments. Analytical techniques such as identification, assay, related substances, residual solvents, metal impurities etc., are developed and validated for drug substances or drug products and their intermediates, raw materials, and excipients. Method validation is outlined as the method of proving that an analytical technique is appropriate for the meant use, and this is often an essential requirement for analytical purposes. Methodology validation results are used to decide the quality, reliability, and consistency of analytical data. Validation parameters are explained in terms of accuracy, precision, linearity, specificity, Limit of Detection (LOD), Limit of Quantification (LOQ), and robustness. This detailed review offers concepts concerning varied strategies to check the stability of the drug and varied validation parameters as per various regulative authorities. The review focused on the concept, criteria, steps, strategy, and importance of analytical method development validation and verification.Analytical method development, validation, and verification are the continuous and interdependent tasks associated with the research and development, quality control, and quality assurance departments. The primary purpose of the analytical method development and validation is to prove that the proposed analytical method is accurate, specific, precise, and robust in the pharmaceutical industry for analysis of a drug moiety as the drug must be manufactured to the highest quality levels. Analytical methodology development has become an essential activity of study. Recent development in analytical methods has resulted from the advancement of analytical instruments. Analytical techniques such as identification, assay, related substances, residual solvents, metal impurities etc., are developed and validated for drug substances or drug products and their intermediates, raw materials, and excipients. Method validation is outlined as the method of proving that an analytical technique is appropriate for the meant use, and this is often an essential requirement for analytical purposes. Methodology validation results are used to decide the quality, reliability, and consistency of analytical data. Validation parameters are explained in terms of accuracy, precision, linearity, specificity, Limit of Detection (LOD), Limit of Quantification (LOQ), and robustness. This detailed review offers concepts concerning varied strategies to check the stability of the drug and varied validation parameters as per various regulative authorities. The review focused on the concept, criteria, steps, strategy, and importance of analytical method development validation and verification.
