Department of Pharmaceutical Sciences, School of Health Sciences and Technology, Dr. Vishwanath Karad MIT World Peace University, Sr.No. 124, MIT Campus Paud Road, Kothrud, Pune, Maharashtra, 411038
*Corresponding Author E-mail: arti.swami@mitwpu.edu.in
Online Published on 25 January, 2024.
Quality of pharmaceutical product is of principle importance by all the regulatory bodies. Failure to meet such quality expectations can lead to massive shift of pharmaceutical companies in share of market. The pharmaceutical industry is supremely regulated industry as it is managed by convincing regulatory bodies. Process analytical technology (PAT) is a method to plan, examine and regulate pharmaceutical manufacturing procedures by examining critical process parameters influencing the critical quality attributes. PAT has been used in manufacturing processes in pharmaceutical industries from decades. PAT involves utilizing diverse techniques and tools to construct quality in pharmaceutical products both physically and chemically by testing at one or more intermediate processing steps. This review endeavors to discover perception tools, goal line, PAT tools in manufacturing, its working and applications, regulatory considerations and benefits. The applications of NIR spectroscopy have extended the added advantages in pharmaceutical industry.
PAT, Regulatory considerations, QbD, Critical quality attributes, ICH