PQ/CMC Project has a requirement to support the concept of Quality Standard to which a substance or drug product component complies.  This concept is similar to IDMP 11238 SPECIFIED_SUBSTANCE_GROUP3 > GRADE.GRADE_TYPE element.

Quality Standard: The established benchmark to which the component complies. [Source: SME Defined].  Examples: USP/NF, JP, etc.

This is a CodeableConcept and 1..*.  FDA plans to use the following value list:  USP/NF, Ph. Eur, JP, BP, Company Standard.