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Section 4 of the guideline is intended to be applied to products that were either marketed prior to, or after, the adoption of this guideline. The two types of products are treated differently. For those marketed after implementation, a further set of requirements (Section 8.5 Lifecycle Management) apply.

The need for further evaluation is defined in terms of changes. For those products marketed before the advent of ICH M7, application of the guideline is limited to the criteria defined within Section 4 of the guideline. This itself is divided into four subsections:

 Changes to Drug Substance

 Changes to Drug Product

 Changes to Clinical Use

 Other Considerations