Survey, assessment and development of quality standards and parameter\'s for brand and generic drugs available in the market

Author : Kunal Roy

Quality can be defined as the suitability of the goods or service to the determined qualifications. Quality control tests help to ensure the total quality of the product. The entire dealing process involves stringent tests to make products totally flawless before they are released into the market. But sometimes recalls and complains occur despite such strong control procedures which presents us with an opportunity to do a survey for new or drugs already present in the market & their availability so that it stands up to the reputation with respect to qualitative and quantitative characteristics with which the product must comply throughout its shelf life. The present work dealís with assessment and development of special quality system 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 review of the data gathered from the batches analyzed and surveyed. Since the markets have opened up due to globalization it is necessary for a product to comply with the standards of the place & throughout the globe.

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