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Every pharmaceutical manufacturer, or let us say manufacturer of any goods, want to manufacture a product of best quality which shall complies with all the applicable regulations, guidelines, specifications etc. In pharmaceuticals, this becomes a bigger challenge as the failure…
July 6, 2020 Gilead Sciences has announced that the European Commission has granted conditional marketing authorization for Veklury® (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19. The conditional marketing authorization was granted in the interest of public…
Pharmaceutical Good Manufacturing Practices (GMP) thrive on Good Documentation Practices (GDP). It is one of the most important requirements of the Quality Management System. It is popularly said that “Anything which is not documented, is not done”. Documentation is the…
No manufacturing firm can design a process where they don’t need to hold the various dispensed, in-process, bulk and finished products for few hours to many months. The duration for which the various materials can be hold under specific environmental…
Jun 18, 2020 The U.S. Food and Drug Administration has issued warning letters to four companies for selling unapproved injectable drug products labeled as homeopathic that can pose serious risks to patient health and violate federal law, as part of…