• Pranita Dhamale

The pharmaceutical industry is undergoing a paradigm shift, fuelled by stringent regulatory expectations and a demand for high- quality safe, and effective drug products. Quality control (QC)and Quality assurance (QA)are the two pillars that support pharmaceutical integrity from raw material acquisition to product release. Traditional QC and QA practices, while effective have been challenged by complex formulations, biologics and personalised medicine, necessitating novel methodologies and technologies. The recent developments in QC and QA that are transforming the pharmaceutical industry are examined in this review. The accuracy and speed of quality assessment have been improved by cutting-edge innovations like Process Analytical Technology (PAT) Real-time Release Testing(RTRT) and high resolution methods like near - infrared (NIR) spectroscopy and Ultra performance liquid chromatography (UPLC). Furthermore, real time monitoring, defect prediction and Adaptive process control are made possible by the use of Artificial Intelligence(AI)and Machine Learning(ML)in predictive quality analytics, which lowers human error and improves compliance. On the quality assurance front, innovations in Quality by Design (QBD), electronic Quality Management Systems (e QMS) and blockchain enabled data integrity systems are strengthening traceability and accountability across manufacturing chains. Standardization has been significantly improved by incorporating regulatory frameworks such as the ICH Q8-Q12 guidelines and global harmonization strategies. Despite these advancements the industry faces several challenges, Including high implementation costs, digital transition barriers in emerging economies and a lack of skilled personnel.by highlighting these transformative developments, this review emphasizes the importance of incorporating modern tools into QC and QA practices to ensure pharmaceutical product integrity, patient safety and regulatory compliance. These emerging strategies strengthen current systems while also paving the way for future innovations in the quality-centric pharmaceutical ecosystem.

Quality Control, Quality Assurance, Process Analytical Technology, AI in pharma, pharmaceutical compliance, Quality by Design

"Recent Advances In Quality Control And Quality Assurance: Enhancing Pharmaceutical Product Integrity And Compliance", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.13, Issue 3, page no.c352-c360, March-2026, Available :http://www.jetir.org/papers/JETIR2603244.pdf

"Recent Advances In Quality Control And Quality Assurance: Enhancing Pharmaceutical Product Integrity And Compliance", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.13, Issue 3, page no. ppc352-c360, March-2026, Available at : http://www.jetir.org/papers/JETIR2603244.pdf