Process Analytical Technology (PAT)

• Date: January 20, 2011
• Source: Admin

Contrary to the existing QA (Quality Assurance) system which used to monitor the quality of the product only at the final stage of production, PAT introduces an approach of monitoring the manufacturing process on a continuous basis which helps to detect and eliminate the problem instantly.  Thus, PAT empowers the assembly line workers to monitor the progress of manufacturing process flawlessly and stop and eliminate quality problems at necessary times.  

Components of PAT

Two major PAT components are:
 

1. It defines “a set of scientific principles and tools supporting innovation”
2. It aims for “a strategy for regulatory implementation that will accommodate innovation”

Objectives of PAT

Major objectives of PAT are:
 

• Enhancing the final product quality;
• Encouraging technological innovation;
• Increasing production efficacy;
• Decreasing operational cost;
• Improving process capacity; and
• Encouraging collaboration between research and development in order to improve overall production efficiency.

Reason for PAT Introduction

With the incessant demand from pharmaceutical companies for increasing production and decreasing manufacturing cost, introduction of PAT became obvious. Along with that, necessity for improving the quality standard and increased drug expectation also made PAT inevitable.
 

PAT also had the objectives of prioritizing science based design, improved production technique and gathering critical data throughout a drug’s life cycle. Therefore, in order to bring new innovation to perform a manufacturing process differently and more efficiently, PAT was initiated.


PAT Tools:

As per the FDA Guidelines, PAT has the following four tools:
 

• Multivariate tools for design, data acquisition and analysis;
• Process analyzers;
• Process control tools;
• Continuous improvement and knowledge management tools.

PAT Will Improve:

With introduction of PAT,
 

• Number of rejects, scrap, and re-processing will decrease;
• By using time measurements and control, entire time cycle will be reduced;
• Increased automation will improve operator safety and cut down human error;
• Facilitating continuous processing to improve efficiency and manage variability;
• Using small-scale equipment (to eliminate certain scale-up issues) and dedicated manufacturing facilities;
• Improving energy and material use and increasing capacity.