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References

  • 1
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Guideline Q2(R1): Validation of analytical procedures: text and methodology. Geneva, Switzerland; 1994. Available at: www.ich.org/LOB/media/MEDIA417.pdf. Accessed December 10, 2009.
  • 2
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Guideline Q6A: Specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances. Geneva, Switzerland; 1999. Available at: www.ich.org/LOB/media/MEDIA430.pdf. Accessed December 10, 2009.
  • 3
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Guideline Q7: Good manufacturing practice guide for active pharmaceutical ingredients. Geneva, Switzerland; 2000. Available at: www.ich.org/ LOB/media/MEDIA433.pdf. Accessed December 10, 2009.
  • 4
    U.S. Food and Drug Administration. Center for Drug Evaluation and Research. Guidance for industry: quality systems approach to pharmaceutical CGMP regulations. FDA. Available at: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070337.pdf. Accessed December 11, 2009.
  • 5
    U.S. Food and Drug Administration. Title 21 Code of Federal Regulations (21 CFR Part 211). Current good manufacturing practice for finished pharmaceuticals. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.194. Accessed December 11, 2009.
  • 6
    Chan CC, Lee YC, Lam H, et al., eds. Analytical Method Validation and Instrument Performance Verification. Hoboken, N.J.: John Wiley & Sons, Inc; 2004.
  • 7
    United States Pharmacopeial Convention. General chapter <1225>: Validation of compendial procedures. Rockville, Md.: United States Pharmacopeial Convention.
  • 8
    U.S. Pharmacopeial Convention. General Chapter <1226>: Verification of compendial procedures. Rockville, Md.: United States Pharmacopeial Convention.