Article

Best Practices For Designing A USP<797>/<800> Compliant Drug Compounding Facility

Source: Germfree

By Carol Houts , VP Quality-Regulatory, Germfree

cleanroom microscope lab iStock-1294339614

The United States Pharmacopeia (USP) plays a central role in asserting the importance of standards for designing, implementing, and maintaining cleanrooms cannot be overstated. Specifically, USP 797 / 800 ensures the provision of safe and quality pharmaceutical products by focusing on aseptic compounding and hazardous drug handling, respectively.

Explore the essential components of cleanroom design necessary for Category 2 drugs to adhere to the updated stipulations within USP 797 / 800 chapters.

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