International Conference on Harmonization Impurity Guidelines—the Industry Perspective

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.