Module 3 - Strategic case studies in practice

ICH Q12 Guideline

low risk to product quality. The reporting category should be defined based on level of risk. A justification of the potential risk for changing ECs and corresponding reporting categories should be provided. A decision tree which illustrates the above step-wise approach to identifying ECs and reporting categories for process parameters is shown in Figure 1. The principles in the decision tree can be applied to identify ECs for other parts of the manufacturing process and control strategy (e.g., relevant elements of input material attributes, equipment, and in-process controls) and associated reporting categories. Figure 1: Decision Tree for Identification of ECs and Associated Reporting Categories for Manufacturing Process Parameters

The details of ECs and the associated reporting category will depend on the extent to which the company can apply knowledge from product and process understanding (i.e., development and experience accumulated throughout the product lifecycle) to manage the risks to product quality. Different approaches can be used alone, or in combination, to identify ECs for manufacturing processes; these include, but are not limited to the following: • Parameter-based approaches , including: o A minimal 2 approach, with a limited understanding of the relationship between inputs and resulting quality attributes, will include a large number of inputs (e.g., process parameters and material attributes) along with outputs (including in-process tests).

2 Also referred to as “traditional” in ICH Q11.

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