DECISION TREE #1: ESTABLISHING ACCEPTANCE …

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Determine impurity level in relevant batches1Determine mean + upper confidence limit for the impurity (Let this = A) ACCEPTANCE criterion = A or B(as appropriate)Isimpurity alsoa degradationproduct?IsA or B greater than thequalifiedlevel? ACCEPTANCE criterion = qualified levelor establish new qualified level2Estimate maximum increase in impurityat retest date using data from relevantaccelerated and long-term stability studiesDetermine maximum likely level as:A + increase in degradation product atappropriate storage conditions.(Let this = B)YESYESNONODECISION tree #1: ESTABLISHING ACCEPTANCE CRITERION FOR A SPECIFIED impurity IN A NEW DRUG SUBSTANCE1Relevant batches are those from development, pilot and scale-up to ICH Guideline on Impurities in New Drug SubstancesDefinition: upper confidence limit = three times the standard deviation of batch analysis dataDECISION tree #2: ESTABLISHING ACCEPTANCE CRITERION FOR A DEGRADATION PRODUCT IN A NEW DRUG PRODUCTDoesdegradationoccur during productmanufacture?

decision tree #5: establishing identity, assay and enantiomeric impurity procedures for chiral new drug substances and new drug products containing chiral drug substances

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