In this second article, we continue defining the path to necessary and sufficient impactor quality specifications. We introduce the need for a careful definition of sufficiency. This definition, in turn, necessarily introduces the concept of acceptable risk. We have therefore set out the philosophy of establishing impactor quality specifications that are sufficient for meeting the batch release criteria for an OIP, although, in general terms, this same philosophy could potentially apply to the development of a control strategy for all new drug products based on measures of their critical quality attributes (CQAs). Ideally, the methodology will guide the developers of new OIPs so they can make sound proposals regarding impactor quality specifications to the appropriate regulators. In turn, regulators need to assure that the specifications for many instruments, of which cascade impactors are only one, are both necessary and sufficient for batch release testing in quality control.
Quality requirements for cascade impactors assigned to batch release testing of a specific drug product; Part II: The concept of “sufficient” as applied to impactor quality specifications
The authors continue describing a philosophy for impactor quality specifications that are sufficient for meeting OIP batch release criteria. Ideally, they hope such methodology would guide developers of new OIPs in making proposals for impactor quality specifications to regulators. In turn, regulators need to assure that specifications are both necessary and sufficient for batch release testing in quality control.