THE INFLUENCE AND IMPACT OF 21 CFR (US FDA) IN PHARMACEUTICAL INDUSTRY

Balasubramanian J.*, Naveena, S. Hari Ram, Eknath Babu and Chenchu Teja Varma Y.

ABSTRACT

The influence of 21 CFR in pharmaceutical industry clarifies the pharmaceutical regulations which had been built from years of experience with FDA and other global regulatory authorities, and knowledge of what regulators expect from pharma companies. In order to ensure quality and safety are maintained, Matrices develops strategies that pinpoint where compliance improvements are needed and how to best take action. Rather than focusing on individual symptoms, a broader approach to locating and remediating systemic quality, regulatory, and compliance issues which gives perfect output. Title 21 is the portion of the CFR that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). This retrospective review works reveals about electronic records, Clinical trials, GLP, drug advertising, marketing, specific requirements of new drugs, OTC, controlled substances, various schedule of drugs from I to V and government wide requirements for drug free work places. This review article highly focuses on drug regulations as per USFDA norms.

Keywords: USFDA - United States for the Food and Drug Administration; GLP – Good Laboratory Practice, OTC – Over the counter.