International Conference on Harmonization Impurity Guidelines—The Industry Perspective

Abstract

As part of the “ICH and the Canadian Drug Regulatory System” workshop the industry provided its perspective on the International Conference on Harmonization (ICH) impurity guidelines. The value of these guidelines informing the basis for international companies to develop global specifications is highlighted and the industry’s concerns regarding regulatory agencies requesting impurity limits, which may be too restrictive when safety is not a concern, are discussed. Some examples of ambiguities and inconsistencies in the current guidelines are provided, including the rounding policy associated with impurity limits and the identification and reporting thresholds in the drug substance impurity guideline. From an industry perspective, the residual solvents guideline provides valuable guidance on acceptable residual levels of solvents commonly used in pharmaceuticals. A strong recommendation is made for revising the drug substance impurity guideline to establish higher identification and qualification thresholds for low-dose drugs.

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References

  1. 1.

    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Harmonised Tripartite Guideline on Impurities in New Drug Substances. (Q3A). Geneva, Switzerland: ICH; Recommended for Adoption at Step 4, March 30, 1995.

    Google Scholar 

  2. 2.

    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Harmonised Tripartite Guideline on Impurities in New Drug Products. (Q3B). Geneva, Switzerland: ICH; Recommended for Adoption at Step 4, November 6, 1996.

    Google Scholar 

  3. 3.

    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Harmonised Tripartite Guideline on Impurities: Guideline for Residual Solvents. (Q3C). Geneva, Switzerland: ICH; Recommended for Adoption at Step 4, July 17, 1997.

    Google Scholar 

  4. 4.

    Drugs Directorate Guidelines. Chemistry and Manufacturing: New Drugs. Ottawa, Ontario: Health and Welfare Canada; 1990.

    Google Scholar 

  5. 5.

    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Draft Consensus Guideline on Impurities in New Drug Substances. (Q3A). Geneva, Switzerland: ICH. Released for Consultation at Step 2, October 7, 1999.

    Google Scholar 

  6. 6.

    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Harmonised Tripartite Guideline on Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and Products: Chemical Substances. (Q6A) Recommended for Adoption at Step 4, October 6, 1999.

    Google Scholar 

  7. 7.

    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Draft Consensus Guideline on Impurities in New Drug Products. (Q3B) Released for Consultation at Step 2, October 7, 1999.

    Google Scholar 

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Correspondence to Peter Jeffs.

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Presented at the DIA/Therapeutic Products Programme Workshop “ICH and the Canadian Drug Regulatory System,” November 15–16, 1999, Montreal, Canada.

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Rousseau, G., Jeffs, P. International Conference on Harmonization Impurity Guidelines—The Industry Perspective. Ther Innov Regul Sci 34, 903–907 (2000). https://doi.org/10.1177/009286150003400326

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Key Words

  • ICH
  • Impurity
  • Quality
  • Drug
  • Industry