International Committee on Harmonization (ICH)

  • Thomas Catalano
Part of the SpringerBriefs in Pharmaceutical Science & Drug Development book series (BRIEFSPSDD)


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.


Quality Risk Management Method Validation Parameters Risk Questions Quality Policy Robustness Study 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


  1. 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. 2.
    Catalano T (2013) Essential elements for a GMP analytical chemistry department. Springer, New YorkGoogle Scholar
  3. 3.
    Hadley K, Fereday MJ (2008) Ensuring competent performance in forensic science. CRC, Boca RatonGoogle Scholar
  4. 4.
    Inman K, Rudin N (2001) Principles and practice of criminalistics. CRC, Boca RatonGoogle Scholar

Copyright information

© Thomas Catalano 2014

Authors and Affiliations

  • Thomas Catalano
    • 1
  1. 1.PharmChem Analytical Consultants, LLCBuffalo GroveUSA

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