The manufacturer of pharmaceutical product is intended to assist to the extent possible in the establishment of a single set of global specifications for new drug substances and new drug products. It provides guidance on the setting and justification of acceptance criteria and the selection of test procedures for new drug substances of synthetic ,chemical origin, and new drug products produced from them, that have not been registered previously. The design and conduct of pharmaceutical development studies should be consistent with their intended scientific purpose. It should be recognized that the level of knowledge gained, provide the basis for science based submission and their regulatory evaluations. The stability studies are designed to evaluate the impact of temperature excursions on product quality that may occur during distribution. Specification address only the marketing approval of new drug product and where applicable, new drug substance, they are applied to products containing synthetic APIs (including antibiotics), semi synthetic antibiotics and synthetic peptides of low molecular weight, but not to higher molecular weight peptides, and complex biotechnological or biological APIs.\r\nThe study present a brief definition of each concept and an indication of circumstances under which it may be applicable.Generally proposals to implement these concept should be justified by the applicant and approved by the appropriate regulatory authority before being put into effect.
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