CHALLENGES IN IMPLEMENTATION OF PROCESS ANALYTICAL TECHNOLOGY (PAT) – A REVIEW
About Author: Amit Surani,
Dept. of Quality Assurance,
M.Pharm, Maliba College of Pharmacy, Surat
Gujarat Technical University
ABSTRACT
According to FDA, Process Analytical Technology (PAT) is a system for designing, analyzing, and controlling manufacturing process through timely measurements of critical quality and performance attributes of raw materials, in-process materials and processes with the goal of ensuring final product quality.
PAT involves the use of different technologies and tools to build quality into the products. Effective PAT implementation is based on detailed, science-based understanding of the physical, chemical and mechanical properties of all elements of the proposed drug product.
Pharmaceutical companies face many challenges while implementing PAT into their new and pre-existing manufacturing processes. This article discusses the challenges encountered by manufacturers and the benefits they can reap by successful implementation of PAT.
