Abstract
GOOD REGULATORY PRACTICE: A PROPOSAL FOR A QUALITY SYSTEM.

Abhijit Sasmal*, Koustav Chowdhury and Tania Sadhu

ABSTRACT

A pharmaceutical company's Drug Regulatory Affairs (DRA) department is crucial. In order to speed up the development and delivery of safety and efficacy in pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, healthcare products to people all over the world, it is concerned with the lifecycle of healthcare products. It provides strategic, tactical and operational direction and support for working within regulations. Professionals in regulatory affairs (RA) work for the pharmaceutical sector, the government, academic research institutes, and clinical facilities. In order to meet the present demands of companies for the global competitiveness, regulatory affairs specialists are required because the pharmaceutical sector in India is expanding extremely quickly. The international regulatory authorities and the pharmaceutical industry are connected through regulatory affairs specialists. A regulatory affair is a relatively young profession that emerged from governments' efforts to protect public health. Large, complicated applications are produced as a result of the substantial paperwork and data that must be included in these submissions. The Pharmaceutical Inspection Cooperation Scheme (PIC/S) was established today to promote a GMP that is universally recognised. It consists of 35 member nations, 11 applicant countries, and 4 international institutions.

Keywords: Drug regulatory affairs, Regulatory agencies, FDA, Pharmaceutical Inspection Cooperation Scheme (PIC/S), GMP, USFDA, CDSCO.


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