Pharmaceutical Manufacturing's Horizon Challenges and Opportunities in Continuous Processing, Advanced Therapy Medicinal Products Regulatory Adaptation, and Quality by Design / Process Analytical Technology Integrati
DOI:
https://doi.org/10.70749/ijbr.v3i8.2150Keywords:
Continuous Manufacturing, Quality by Design (QbD), Process Analytical Technology (PAT), Advanced Therapy Medicinal Products (ATMPs), Real-time Release Testing (RTRT).Abstract
Background: The pharmaceutical industry is evolving, focusing on the quality, efficacy, and accessibility of innovative treatments while incorporating QbD, PAT, and regulatory frameworks, despite challenges like high initial investment and system complexity. Objective: This review looks at pharmaceutical manufacturing, paying special attention to quality by design, continuous manufacturing, regulatory concerns, challenges with advanced therapy medications, and the use of process analytical technology. Methodology: This review looks at the technological challenges, financial implications, regulatory changes, benefits, drawbacks, digital transformation, and interdisciplinary collaboration of continuous manufacturing, ATMPs, QbD, and PAT. Conclusion: The pharmaceutical manufacturing sector is going through a significant transition as continuous manufacturing offers efficient, high-quality drug manufacture. It is crucial to successfully integrate CM, regulatory adaptation, QbD and PAT, interdisciplinary collaboration, trained staff, and digital solutions in order to create safer, more effective, and more accessible medications.
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