Regulatory Comparative Quality Systems of India and USA and its Significance in Pharmaceutical Industry Facilities

Abstract

The intentions of the current study are to compare the regulatory requirements of USFDA and CDSCO-Schedule M in GMP with significance to the pharmaceutical industry to speed up the criteria for enforcement to facilitate the regulatory approval of specified pharmaceutical products in the United States and India. The literature search is done using different resources, such as regulatory authority websites, pharmaceutical review articles, journals and public domains. To discuss the numerous dilemmas, root causes and challenges confront by pharmaceutical companies and to suggest remedial and pro-active measures to GMP issues and all pharmaceutical manufacturers are required to develop and enforce effective quality control systems in order to ensure quality. Whereas the regulated markets like the United States have well-established guidance compared to emerging markets like India on good manufacturing practice compliance, to assess the effectiveness of this quality management systems, inspections are carried out on manufacturing units. The primary objective of the analysis is to differentiate between the type of application or license that causes the inspection and the outcome of the inspection and to also provide enough details identified by the authority during the evaluation.