Rationale

The definition for "quality" is different than the definition in the ASTM standard on CAPA. The definition in the Terminology standard focuses on specifications of "quality" in terms of product (i.e.; purity, identity, strength, composition, packaging, labeling, manufacturing, and storage). However, "quality" extends beyond just "product" quality. Good Documentation Practice (GDP), meeting customer requirements , addressing root cause of issues, etc. are a few examples of where "quality" extends beyond product specifications.