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GxP are quality standards and regulations which are to be followed in specific fields. GxP is a concept of good practices where G stands for ‘Good’, x is an acronym which stands for particular field like ‘Manufacturing/Laboratory/Clinical, etc.’ and P…
Principles of Quality Risk Management found their application in our day to day life, apart from their application in the industry, production, regulations etc. In pharmaceutical industries principles of QRM found their application for both manufacturers as well as reviewers/…
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…