International Committee on Harmonization (ICH)
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The ICH guidelines are discussed in this chapter. Items such as method validation parameters and the acceptable criteria are described in detail. In addition the concepts and implementation of Quality Risk Management and Quality Assurance are discussed.
KeywordsQuality Risk Management Method Validation Parameters Risk Questions Quality Policy Robustness Study
- 1.International Committee on Harmonization (ICH), Q2(R1), (2005), Q7A(2001), Q9(2006), Q10(2009), U.S. Food and Drug Administration: Silver SpringGoogle Scholar
- 2.Catalano T (2013) Essential elements for a GMP analytical chemistry department. Springer, New YorkGoogle Scholar
- 3.Hadley K, Fereday MJ (2008) Ensuring competent performance in forensic science. CRC, Boca RatonGoogle Scholar
- 4.Inman K, Rudin N (2001) Principles and practice of criminalistics. CRC, Boca RatonGoogle Scholar