Assess the effects of the change
Assess the effects of the change means to evaluate the effects of a manufacturing change on the identity, strength, quality, purity, and potency of a drug product as these factors may relate to the safety or effectiveness of the drug product.
Source
21 CFR § 314.3
Scoping language
The definitions and interpretations contained in section 201 of the act apply to those terms when used in this part.