Biomedical Engineering Reference
In-Depth Information
International Conference on Harmonization. 1997. Q5D: Derivation and characterisa-
tion of cell substrates used for production of.
International Conference on Harmonization. 1997. S6: Preclinical safety evaluation of
biotechnology-derived pharmaceuticals. Geneva, Switzerland.
International Conference on Harmonization. 1999. Q5A: Viral safety evaluation of
biotechnology products derived from cell lines of human or animal origin Q5A.
Geneva, Switzerland.
International Conference on Harmonization. 2000. Q7: Good manufacturing practice
guide for active pharmaceutical ingredients. Geneva, Switzerland.
International Conference on Harmonization. 2002. Q5E: Comparability of biotechno-
logical/biological products subject to changes in their manufacturing process.
Geneva, Switzerland.
International Conference on Harmonization. 2005. Q9: Quality risk management
Geneva, Switzerland.
International Conference on Harmonization. 2006. Q3A: Impurities in new drug sub-
stances. Geneva, Switzerland.
International Conference on Harmonization. 2006. Q3B: Impurities in new drug prod-
ucts. Geneva, Switzerland.
International Conference on Harmonization. 2007. Q3C: Impurities: Guideline for
residual solvents. Geneva, Switzerland.
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Geneva, Switzerland.
International Organization for Standardization. 2006. Sterilization of health care
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International Organization for Standardization. 2006. Sterilization of health care prod-
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