Six-Sigma Model in Pharma Industry: Part – II

The essence of every medicinal product is quality. Future optimization of multifaceted drug delivery systems, pharmaceutical compounding, and its quality assurance will benefit from knowledge of the proactive formulation design and process parameters through the quality by design (QbD) and noninvasive as well as predictive PAT concept for enhancing pharmaceutical development, production, and quality control to improve the real-time release testing process. Moreover, pharmaceutical continuous manufacturing may address the quality-by-design framework, which builds the foundation for the future smart manufacturing stated by quality-by-control, with an awareness of process dynamics and a suitable control strategy. Utilization of digital twin and AI to hasten, improve the complex process, process modeling, and prediction helps gain incremental value than statistical as well as analytical process. Numerous material combinations and additive manufacturing technologies may be employed and integrated to build novel low-cost one-step compounding of peculiar multifunctional components to meet a variety of purposes. Additionally, embracing digitalization, smart sensors, and automation in pharmaceutical industry enables safe production by transforming business model of healthcare companies and its amalgamation with quality assurance renders more controlled and designed process. This chapter provides details of the proactive QbD approach, in-line analytical technique PAT, continuous manufacturing of the pharmaceutical drug product and drug substance, modeling and forecasting via the use of AI and digital twins, and lastly managing supply chain and continuous improvement for establishing chronic operational excellence and organizational agility.