1FDA. Guidance for Industry Process Validation: General Principles and Practices[EB/OL3. [2011-01-24]. http://www. fda.gov/ ion/Guidances/UCM070336.pdf.
3EMEA. Note for Guidance on Process Validation [EB/ OL]. [ 2001-03-01 ]. http://www.ema.europa.eu/docs/ en_GB/documentjibrary/Scientific guideline/2009/09/ WC500002913.pdf.
4WHO. Validation: Annex 4, Supplementary Guidelines on Good Manufacturing Practices: Validation [EB/OL]. [2006-01-12]. http://www.who,int/medicines/publications/pharmprep/TRS 937.pdf#page= 119.
5EMEA. Guideline on the Limits of Genotoxic Impurities EEB/OLJ. 2006-06-283. http://www.ema.europa.eu/docs/ en_GB/document library/Scientific_guideline/2009/09/ WC500002903.pdf.
