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Predicated purge factors can be determined either by a paper‐based approach or by knowledge‐based software (see Chapter 9). Individual purge factors are predicted for each PMI present within the process. The purge factors are defined based on the known, or estimated, purging capacity of the downstream chemistry and operations. Based on the outcome of the assessment and comparison to the required purge factor, the resultant purge ratio is then used to determine which ICH M7 control strategy is appropriate and what, if any, further evidence may be required to support the claim that the PMI in question is purged. A systematic process relating the purge ratio to data requirements and regulatory strategy was defined and is illustrated in the decision tree, Figure 3.2.