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What is cGMP manufacturing and why is it important in drug development?

Current Good Manufacturing Practices (cGMP) is part of a quality assurance system monitoring the manufacture and testing of drugs. Before a compound can be tested in humans, regulatory bodies require sponsors to demonstrate that the compound has been manufactured in accordance with these quality standards. To learn more about cGMP and why it is important for drug development click on the links below.

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FDA Guidance

• FDA: Guidance for Industry – cGMP for Phase I Investigational Drugs
• FDA: Drug Applications and Current Good Manufacturing Practice (CGMP) Regulation

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