Pharmaceutical manufacturing is inefficient largely because it’s been incentivized to be just that. Manufacturing processes are set up early in the life cycle of the new product and then frozen. Any undocumented changes to the processes risk citation (483 or Warning Letter) or shut-down (Consent Decree) by the FDA. In short, it’s not worth the effort to change or innovate. So while a scientific approach is taken to creating the drugs themselves, a very unscientific approach is taken to the production of the drugs after approval has been granted.

PAT – Understanding and Controlling Your Process

The intent of the Process Analytical Technology initiative is for the FDA and pharmaceutical companies to work together to apply scientific principals to the actual manufacturing of drugs. The concept is to design quality into the product and process (Quality by Design) rather than test quality into the product as is done today.

The first step is to gain an understanding of the process – identifying and explaining all critical sources of variability, then controlling them effectively. A process is considered controlled when final product quality attributes can be accurately and reliably predicted. From there, steps can be taken to improve the process.

PAT tools, as defined by the FDA, consist of sensors for data acquisition, analyzers that can generate a useful process signature with the measurements, control tools that let you modify a process and maintain a desired state, and knowledge management tools that allow for continuous improvement.

But there are significant challenges. In many facilities, instruments feature distinct software environments, diverse data formats and different protocols. What’s more, the amount of data that is created by PAT sensors is more complicated than the data produced by most DCS or PLC systems – often more than 4,000 distinct data points are logged every few seconds. These quantities of data must be collected, stored, displayed, transmitted and processed to provide timely and manageable information about the process.

Proficy RX – A Solution for PAT Initiatives

Proficy Rx is a software application specifically designed for Process Analytical Technologies. It provides standardized control and networking of multiple instruments, insures similar data formats and protocols, and provides a single development environment for system design, analysis and control. Dedicated tools ensure compliance with 21 CFR Part 11.