The concept of Process analytical technology (PAT) has revolutionized and redefined the mechanism in the segment of pharmaceutical manufacturing.
The pharmaceutical manufacturing industry that had to work within the rigid constraints of regulation for many years has welcomed this initiative by the U.S. Food and Drug Administration for current good manufacturing practices (CGMPs). This has been primarily because PAT has made things easier and simplified for the pharmaceutical manufacturing industry to adopt new technologies for improving manufacturing.
Process analytical technology can be defined as an extensive system to design, analyze, and control pharmaceutical manufacturing via timely quality measurements along with performance attributes of materials and processes.
PAT is a real-time testing and adjustment process that includes physical, chemical, mathematical, and microbiological risk analysis that is executed in appropriate manner. The fundamental principle of this approach includes quality cannot be tested but it can be instead built by design into the medicinal product.
Till recently, the pharmaceutical manufacturing industry was reluctant to embrace PAT for many reasons. The primary reason was that PAT application will further add to current regulatory requirements. Secondly, this new technology will bring out more questions related to suitability, validation, and chemometrics of the method. Thirdly, many experts believe that regulatory uncertainty/risk results in “Don’t Tell” or “Don’t Use” practice.
PAT was not widely accepted initially by the pharmaceutical manufacturing sector as significant process and formulation changes would have been required during technology transfer and scale up. To add to that, several “bridging” studies such as accelerated stability testing and human bioavailability would have been almost necessitated for ensuring unchanged safety and efficacy profile.
Advantages Of PAT
PAT offers many advantages, including but not limited to:
- Providing high quality drugs to the general public in a timely manner;
- Optimal utilization of private and public resources to meet growing healthcare requirements;
- Reaping advantages of a variety of new drug development opportunities that would be created by advancements in the segments of Biology and Chemistry
Process analytical technology proves its real mettle for Blending purposes. It offers the potential to reduce cycle time and scrap. In addition to these advantages, PAT could be useful to facilitate improved and efficient control of raw materials. Moreover, PAT is beneficial to reduce the likelihood of “segregation” post blending step and also facilitates adequacy of mix in the context of all critical components.
Fostering a culture of continuous process improvements, this approach has the prowess of acknowledging a critical reality: manufacturers of life sciences’ products cannot rely on fixed process control schemes for creating repeatable results. Manufacturers are bound to face variability issues in product quality because of variability in equipment, raw materials, and processing conditions and these variabilities are unavoidable. Therefore, the need to have a robust strategy for developing processes with control and measurement capabilities like PAT were required that have the ability to compensate for process variability.
The pharmaceutical manufacturing industry can easily reap benefits of this technology and achieve a high degree of repeatability and efficiency in processes and sub-processed via active management of the processes to make the concept of Quality Assurance a real-time and continuous activity. In short, PAT is the word to reduce over-processing, minimize rejects, and improve consistency to bring a broader change in pharmaceutical manufacturing.