ValueSeverity
1Negligible: Has no potential to have an adverse effect on identity, strength, quality, purity or potency of a drug product
2Minor: Has minimal potential to have an adverse effect on identity, strength, quality, purity or potency of a drug product
3Moderate: Has moderate potential to have an adverse effect on identity, strength, quality, purity or potency of a drug product
4Major: Has a substantial potential to have an adverse effect on identity, strength, quality, purity or potency of a drug product
ValueFrequency
1Highly unlikely: The probability of the event occurring is so low that it can be assumed that the event will not occur
2Unlikely: Event not expected to occur, but theoretically possible
3Likely: Event may occur and/or has occurred in the past
4Highly likely: Event expected to occur
ValueDetectability
1Readily detectable: Will be detected
2May be detectable: May be detected
3Not detectable: No mechanism for detection