Quality by Design in the CMO Environment - - BioPharm International

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Quality by Design in the CMO Environment


BioPharm International
Volume 20, Issue 12

Susan Cook is a scientist I, Katherine A. Patton is a scientist I, and L. Rochelle Bazemore, PhD, is a staff scientist, all at Diosynth Biotechnology, NC, 919.388.5700,

REFERENCES

1. Juran J. Quality by Design. Mankato, MN: The Free Press; 1992.

2. US Food and Drug Administration. Guidance for industry: Q8 pharmaceutical development. Rockville, MD; 2006 May.

3. US FDA. Guidance for Industry: PAT—a framework for innovative pharmaceutical development, manufacturing, and quality assurance. Rockville, MD; 2004 Sept.

4. The PAT Team and Manufacturing Science Working Group. Innovation and continuous improvement in pharmaceutical manufacturing—Pharmaceutical cGMPs for the 21st century. Rockville, MD; Aug 2002.


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