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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…
As a part of regulatory requirements, we prepare numerous documents. Preparing documents shall not be treated as a burden but shall be considered as an activity of creating proofs or evidences that shows one’s true self. There are many types…
Pharmaceuticals in general not only produce drugs but they also produce tons of data. Regulatory agencies across the globe insist on generation of data for each and every activity. We should understand that there is value in data generation. Data…