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Abstract

REGULATORY REQUIREMENTS AND REGULATORY OPERATIONS IN PHARMACEUTICALS

Saurabh D. Bhandare*

ABSTRACT

Regulatory Agencies or Drug Regulatory Agencies in a pharmaceutical industry acts as the operational interface between the pharmaceutical companies and drug regulatory agencies or authorities that are to be workforce for regulatory purpose across the world. These agencies look after the regulatory requirement and setup standards and procedural requirements for pharmaceutical products and API manufacturing. These agencies are involved in regulatory operations based on standard procedures which have specific operation procedures called as SOP‟s that are known as Standard Operating Procedures. The regulatory agencies sets standards based on clinical requirements and obtained data for safety of drug and drug products as a pharmaceutical product/API. The important roles of such agencies and authorities are based on evaluation of clinical safety data and to ensure protection of human health ensuring all the parameter such as: safety, efficacy and quality of drugs ensuring appropriateness and accuracy of products information.

Keywords: Regulatory Agencies, U.S. FDA. MHRA.


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