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U.S. Department of Health and Human Services

About FDA

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Guidance and Manuals

                   

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Guidances for Industry

Guidances for Industry promote understanding of, and compliance with, Good Manufacturing Practice (GMP) requirements.

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CGMP QandAs

QandA's provide a prompt and succinct guidance mechanism to enhance understanding of GMP expectations.

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Guides to Inspection

These guides are reference materials for inspectional personnel.

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Other Related Guides and Manuals

FDA publishes various other manuals and guides regarding our inspection and compliance work.

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