Active Pharmaceutical Ingredients (API) Regulations in India, USA & Europe: A Comparative Study

Abstract

ICH Q7 i.e., Good Manufacturing Practice guide for Active Pharmaceutical Ingredients was the late outcome of ICH. The ICH Q7 Guideline is originally based on a PIC/S draft guideline on API and was adopted by PIC/S in 2001, then integrated as part II of the PIC/S GMP Guide in 2007.Q7 is a firm list of what makes an operating Pharmaceutical Quality System. Active Pharmaceutical ingredient is the crucial part of any drug product that can directly influence the safety and efficacy of the medicinal product which may endanger the life of the patient. For this, we have assessed the knowledge on regulatory guidelines adopted by three different counties and to observe API has an appropriate manufacturing process that country should follow the stringent rules under the country’s respective regulatory barrier. We therefore looked onto the Main component of drug product i.e., ‘API’ taking into consideration the regulatory requirements associated with it in 3 different countries and the quality control parameters associated with same. This study is the Elucidation of Regulatory Requirements of GMP i.e., the part of Quality Assurance for API in different countries and guidance for drug industry whose intention is to harmonize actions or processes within a specific discipline. During this study we strictly followed three different regulatory guidelines followed by USA (USFDA), INDIA (SCHEDULE M), EUROPE (EUROPEAN UNION VOL 4). It is imperative to manufacture API abiding by the standard guidelines for subsequent processing and formulation of high-quality raw material.