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Looby M, Ibarra N, Pierce JJ, Buckley K, O’Donovan E, Heenan M. Application of high quality by design principles case study case analysis development and expertise transfer of case solution major procedure development for case research manufacture of case solution recombinant protein. Biotechnology Progress 2011;27:1718 29. 4. Q9: Quality Risk Management. ICH Harmonized Tripartite Guidelines. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2006. 5. Q10: Pharmaceutical Quality System, ICH Tripartite Guidelines. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2007. 6.
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