The new ICH guideline is a major step forward in ensuring the quality of APIs. How does the FDA plan to ensure that they are applied and interpreted consistently by field investigators, and who, when, and how it will be applied to overseas suppliers? Additionally, it is really encouraging to see the support and participation of FDA in this important series of workshops. How does the Agency plan to carry through this commitment within its own organization, for example, training of field staff, key review personnel in the application of Q7A to API manufacturing?