1. Quality by design for biopharmaceuticals
2. US Food and Drug Administration.Pharmaceutical cGMPs for the 21st Century—A risk‐based approach.2004.http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/UCM176374.pdf.
3. Department of Health and Human Services Food and Drug Administration.PAT Guidance for Industry – A Framework for Innovative Pharmaceutical Development Manufacturing and Quality Assurance.2004.
4. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.ICH harmonised tripartite guideline: Pharmaceutical development Q8(R2).2009.http://www.ich.org/fileadmin/PublicWebSite/ICHProducts/Guidelines/Quality/Q8R1/Step4/Q8R2Guideline.pdf.
5. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.ICH harmonised tripartite guideline: Quality risk management (Q9).2005.http://www.ich.org/fileadmin/PublicWebSite/ICHProducts/Guidelines/Quality/Q9/Step4/Q9Guideline.pdf.