Narrow-Focused Development Program

This week, I will address the first of nine common CGMP Quality System shortcomings; Narrow-Focused Development Program.

Current Pharmaceutical Quality Systems tend to inherit a process/product designed and developed by a completely different internal organization. The research and development groups are typically concentrating on the enormous task of finding a suitable molecule and developing it into a useful drug product.

Consequently, commercial manufacturing efficiency and robustness is not typically the primary objective on anybody's agenda. Due to the tremendous resource requirements to research and develop a product, extensive product/process characterization knowledge is not often obtained prior to commercial scale-up.

To compound the issue, commercial management is often not introduced to the new product/process until the initial stages of technology transfer. By that time, it may be difficult for value-added input to be provided.

With these development restrictions, the initial commercial scale-up of a product is often less than robust. The first several years of commercial manufacturing often involve working through the inherited product/process short-comings. This trial-by-fire experience is often clumsy and inefficient.

To overcome this shortcoming, the Quality Unit should take an early interest in the product development and characterization process and continue that investment through the life cycle of the product. The Quality Unit should view product reviews as an opportunity to provide continual product improvement and characterization input.