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India is a country which has a drug regulatory system operating at the Central Level as well as the State Level. At Central level, Central Drugs Standards Control Organization (CDSCO) is the organization which has been given the prime responsibility…
Indian Pharma Sector often boasts about being known as Pharmacy of the World. There is no doubt that Indian pharma sector has grown by leaps and bounds. In the rush of achieving more and more it has been observed that…
As per regulatory requirements, each API, inactive ingredient, finished good, packing material and other related material shall be tested as per the specifications before use and prior to their release in the market for commercial use. But is it required…
Parametric release is defined as the system of release that gives the assurance that the product is of the intended quality based on information collected during the manufacturing process and on the compliance with specific GMP requirements related to Parametric…
The whole pharma world goes berserk in meeting the ‘product specifications’ as required by various regulatory authorities. Pharmacopeial specifications, In-house specifications, product specific specifications are various types of specifications that are required to be met by a product before release…