1. ICH. Harmonization for Better Health. 2017 [cited March 8, 2017]; Available from: http://www.ich.org/home.html.
2. PDA Technical Report No. 56 Revised 2016 (TR 56) Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance (API or Biological Active Substance);Eylath,2016
3. FDA, Pharmaceutical cGMPs for the 21st Century. Department of Health and Human Services, US Food and Drug Administration, 2004.
4. Risk management applications in pharmaceutical and biopharmaceutical manufacturing;Mollah,2013
5. Quality by design for biopharmaceuticals: principles and case studies;Rathore,2009