Regulatory Challenges in Chemistry, Manufacturing and Controls

Abstract

This chapter provides a list of product quality tests for topically applied drug products. The limitation in local pharmacokinetics (PK) knowledge and tools impedes the chemistry, manufacturing and controls (CMC) development of locally acting dermal systems for both new and generic drugs. One can expect that CMC information to support such a product may be more than what is typically required for a simple solution/suspension/emulsion. With the availability of cleaner medical grade plastics and more sophisticated manufacturing equipment/process, the aforementioned CMC challenges have been overcome. Traditional dermatological product development was often empirical in CMC activities. CMC overlook is usually due to an ignorance of the clinical/regulatory implications of CMC elements. Early identification of critical product attributes and important manufacturing process parameters is essential to the eventual success in the development. A non-aqueous, volatile formulation was uncommon in the past due to challenges in manufacturing and handling as well as concerns related to safety and quality.