AN OUTLINE OF QUALITY GUIDELINES FOR DEVELOPING AND VALIDATING ANALYTICAL PROCEDURES

The International Council for Harmonization (ICH) which aims to harmonize, has altered how pharmaceutical regulations are applied and how drugs are being developed. Pharmaceutical companies use analytical techniques to perform research and development and to manage the inputs and outputs of a process. These analytical methods should routinely produce high-quality data to support decisions while controlling the remaining risks and uncertainties. This review article aspects the highlights of analytical procedure validation and development (ICH Q2 (R2) and ICH Q14). Both the guidelines have been produced by one panel of subject-matter experts and are currently accomplishing the crucial ICH landmark of Step 2 publishing for public comment. The ICH brings both regulatory agencies and pharmaceutical industries to discuss the scientific and technical aspects of drug approval. Since its beginning in 1990, ICH has regularly progressed to meet the international challenge of drug development. ICH’s purpose is to promote better peace worldwide to ensure that secure, useful, and elevated medicines are being developed and registered in the most resource-efficient manner possible. The new guideline in this pair, ICH Q14, describes the science, risk-based approach, and quality systems to enhance the process and product quality for the development and maintenance of analytical procedures. While Q2 (R2) focuses on including a multivariate model that covers the validation principles for the use of analytical procedures. Applying these guidelines will improve regulatory communication between the industry and regulatory agencies and additionally facilitate post-approval changes to analytical techniquess.