1 | Negligible: Has no potential to have an adverse effect on identity, strength, quality, purity or potency of a drug product |
2 | Minor: Has minimal potential to have an adverse effect on identity, strength, quality, purity or potency of a drug product |
3 | Moderate: Has moderate potential to have an adverse effect on identity, strength, quality, purity or potency of a drug product |
4 | Major: Has a substantial potential to have an adverse effect on identity, strength, quality, purity or potency of a drug product |