Process Analytical Technology is a way to plan, study, and control manufacturing processes by taking measurements at the right time during the process. It looks at raw and in-process materials to make sure the quality of the final product. The PAT is now being used in the pharmaceutical industry, where it is seen as a technology that can help companies better follow manufacturing regulations. PAT focuses on the manufacturing process to improve the current drug quality system's basic idea, which is that quality can't be tested into products; it should be built-in or designed.
In 2001, the Food and Drug Administration (FDA) started PTA to make it less likely that a bad product would be made. With the help of PAT, pharmaceutical companies can now improve the efficiency of their processes and make better products. PAT is a method that fits with what the FDA thinks about quality, which is that it is not a matter of testing but of design. Products are not tested to see how good they are; they are made that way.
PAT is neither a thing nor a service. It is an idea, a way of doing things, or a plan for how to do things, depending on how you use it. As pharmaceutical companies work hard to follow the rules set up by regulators, the PAT market is growing and changing quickly. You can buy the tools and technologies that are part of the framework, as well as the services and skills you need to put qualitative analysis into action.
The benefits of using PAT are:
- Keeps from having to reject and reprocess.
- Gives products the same look and feel
- Makes it faster to switch between products
- Lowers the cost of processing
- Improves quality
- Meets all of the rules and regulations.
- Increases automation to make operators safer and cut down on mistakes made by people.
The goal of the PAT framework is to come up with and build well-understood processes that will always guarantee a certain quality at the end of the manufacturing process. A process is usually called "well understood" when all of the important sources are found and explained correctly.
