Protocol for Evaluation of Virus Inactivation Using Low-pH Treatment

9. References and Related Documents

1. 1.↵
   Food and Drug Administration (FDA). Guidance for industry. Process validation: general principles and practices. FDA: Bethesda, MD, January, 2011.
2. 2.
   International Conference on Harmonisation (ICH). Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, ICH Q5a(R1), 23 September 1999.
3. 3.
   Guideline on virus safety evaluation of biotechnological investigational medicinal products, EMEA/CHMP/BWP/398498/2005, 1 February 2009.
4. 4.
   FDA. Points to consider in the manufacture and testing of monoclonal antibody products for human use. FDA, February 28, 1997.
5. 5.
   Parenteral Drug Association Technical Report 47. Preparation of Virus Spikes Used for Virus Clearance Studies, 2010.