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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…
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…
Oct, 24 2020 Gilead Lifesciences Inc.'s Veklury (Remdesivir) has become the first treatment for COVID-19 to receive the U.S. Food and Drug Administration approval. The drug is approved for use in adult and pediatric patients 12 years of age and older…
The objective of any pharmaceutical manufacturing firm is to manufacture a product which fulfils all the requirements of being a product of quality and is also safe and efficacious. The quality of material shall be maintained not only during the…
Sep 04, 2020 The US Food and Drug Administration has issued a warning letter to Mylan Laboratories Limited's plant in Telangana for significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). USFDA in their letter dated…