Request Copyright Permission

Managing the Supply Chain for Inhaled Products in the Regulated Marketplace

Son Y, Chamarthy SP, Donovan B, Karande A.

RDD Asia 2014. Volume , 2014: 89-98.

Abstract:

In this paper, we discuss considerations for supply chain management of inhaled products for regulated markets. Specifically, we demonstrate how to utilize the powerful statistical tool, process capability ratio (Cpk), to assess and further manage the process capability for inhaled products, their supply chain management and detection of root causes, leading to out of specification (OOS) results in a final drug product. A representative data set is described to demonstrate process capability in a dry powder inhaler (DPI) manufacturing process. Cpk values of critical quality attributes (CQAs) for upstream manufacturing processes (micronization, blending with carrier, and filling into devices) and final product performance testing (down-stream aerodynamic performance testing) were evaluated. For the illustrated data set, upstream manufacturing showed high process capability, while the final product tests indicated unstable process capability. The variations in final product performance were demonstrably expected, since those drug product performance measures demonstrated known variability, independent of the manufacturing process. We found that the use of a quantitative evaluation tool, Cpk, helped improve process capability and manage the different supply chains by identifying non-natural variations in the manufacturing and release processes for a DPI.