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STEPS TO BE FOLLOWED DURING REGISTARTION OF DRUG PRODUCT WITH CRITICAL PARAMETERS

K.Jyothirmaie*, D.Nagarjuna Reddy, M.V.Nagabhushanam, B.Brahmaiah, G.Ramakrishna

Registration of a drug product is a vital task in the world countries. The quality , safety and efficacy plays an important role during the drug registration process. For better treatment, and also for the best safety and efficacy of the drugs must be maintained and rationalize for public security. The requirements of drug products are harmonized in regulatory countries by common technical document. The main step is to know the detailed study about the dossier. The quality, safety and efficacy has its own role in the dossier. ICH brought regulatory authorities and pharmaceutical industries of Europe, Japan and Us. This paper approaches with the critical parameters during drug product registration in the form of dossier. Keywords: Dossier, Registration, Drug product, Critical parameters.

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