Asian Journal of Research in Chemistry
  • Year: 2025
  • Volume: 18
  • Issue: 6

Role of Process Analytical Technology in Enhancing Quality Assurance

  • Author:
  • S. Kunal Salunkhe1,*, Sanket K. Maske1, R. Amol Pawar1,2, V. Vikas Patil1, S. Pankaj Patil1
  • Total Page Count: 7
  • Published Online: Feb 23, 2026
  • Page Number: 420 to 426

1Department of Quality Assurance, Kisan Vidya Prasarak Sanstha’s, Institute of Pharmaceutical Education, Boradi, 425428

2Research scholar, Sankalchand Patel University, Visnagar-384315 (Gujarat-India)

*Corresponding Author E-mail:

Online published on 23 February, 2026.

Abstract

In terms of enhancing "the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance," Process Analytical Technology (PAT) assures to bring about a larger, brighter future’’. All regulatory authorities focus a high priority on Quality of pharmaceutical Product The pharmaceutical industry may see a significant shift in their market share if these quality standards are not met. The pharmaceutical sector is supremely regulated industry since it is overseen by several regulatory organizations. Process analytical technology (PAT) is a method to plan, assess and regulate pharmaceutical production methods by examining essential process parameters influencing the critical quality features.

Keywords

PAT, Pharmaceutical manufacturing, Quality assurance, Real-time monitoring, FDA, Chemometrics, NIR spectroscopy, Fiber-optic probes, ATR probe, Regulatory compliance