Critical Process parameters (CPP).

Process analytical technology (PAT) has been defined as a mechanism to design, analyze and control pharmaceutical manufacturing processes through measurement of critical process parameters which affect critical quality attributes. PAT checks the quality of raw material attributes both physically and chemically (i.e. at off-line, on-line, in-line). PAT involves a shift from testing the quality of building to the quality of products by testing at several intermediate steps. PAT saves a huge amount of time and money required for sampling and analysis of products. Pharmaceutical companies face many challenges and problems while implementing PAT into their new and pre-existing manufacturing processes. The potential for improved operational control and compliance resulting from continuous real time quality assurance was highlighted as a likely benefit that would result from PAT implementation. In this paper, we will start with brief PAT concepts, Introduction, PAT tools, Pat implementation and a review of their application in the wider pharmaceutical industry.