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http://academy.gmp-compliance.org/guidemgr/files/PAT-FDA-6419FNL.PDF
. Accessed 20 Nov 2018
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https://www.ich.org/products/guidelines/quality/quality-single/article/pharmaceutical-development.html
. Accessed 15 Nov 2018
3. I.C.H. (2005) Q9 Quality risk management.
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. Accessed 15 Nov 2018
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. Accessed 15 Nov 2018
5. Rathore AS, Winkle H (2009) Quality by design for biopharmaceuticals. Nat Biotechnol 27:26.
https://doi.org/10.1038/nbt0109-26