Review article- SURVEY, ASSESSMENT & DEVELOPMENT OF QUALITY STANDARDS AND PARAMETERS FOR BRAND AND GENERIC DRUGS AVAILABLE IN THE MARKET

Mr. Kunal Roy

ABSTRACT

Quality can be defined as the suitability of the goods or service to the determined qualifications. Both the in process and finished product quality control tests help to ensure the total quality of the product. The present work deal’s with survey, assessment and development of special system for such quality specification for the medicines. The specification limits of the finished product at the time of batch release are set by the marketing authorization applicant such that the specifications proposed at the end of shelf life are guaranteed and are established on the basis of a critical detailed review of the data gathered from the batches analyzed and there is also a need of after-market survey and quality work done to standup to a brand image power directly to the masses. Since the markets have opened up due to globalization it is necessary for a product to comply with the standards of the place where it is to be marketed and will open constant quality acceptance of the product throughout the globe.

Keywords: Quality, globalization, brand, shelf –life, recall.