Process analytical technology (PAT) is a system for designing, analyzing, and controlling manufacturing processes through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and inprocess materials to ensure final product quality. The term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner. The emphasis in PAT is on the manufacturing process to amplify the basic premise of the current drug quality system: quality cannot be tested into products; it should be built-in or should be by design.
The scope of the PAT focus group is the consideration of PAT as a scientific discipline for enhancing product and process understanding and controlling of pharmaceutical manufacturing processes. This will encompass applications of PAT in both the manufacturing and research and development environments including but not limited to the drug substance/active pharmaceutical ingredients route development and manufacturing control; drug product/formulations and process development and manufacturing control; raw materials; excipients; biologicals; animal health products; and generic products.
The focus group is concerned with PAT applied throughout the lifecycle of a product including research and development, scale-up, tech transfer, commercial manufacturing, and also cases involving contract research organizations. The focus group aims to consider the regulatory, academic, and industrial perspectives of the ramifications and issues of PAT.
To provide leadership in the area of PAT by:
- providing an accessible forum for discussion across industry, regulatory agencies, and academia for improved understanding, utilization and implementation of PAT.
- specifically exchanging emerging scientific and technical accomplishments and experiences and the latest regulatory information on PAT.
- proactively presenting position statements for the AAPS sections with regard to PAT issues.
- serving as a communication link between the AAPS sections and IFPAC, ASTM, ISPE, and Parenteral Drug Association on PAT activities, thereby establishing a center of excellence in PAT for the MSE, APQ, and RS sections.
- Effectively communicate the technical advances, changes in regulatory viewpoint and new applications of PAT across industry, academia, and regulatory groups.
- Perpetuate the concept of PAT at a scientific level by providing programming that brings examples of PAT into the public domain.
- Impact industry standards for utilization of PAT in the pharmaceutical industry through programming and communications from the PAT focus group.
- Catalyze opportunities to expand targeted academic support and collaborations on topics involving PAT.
Section affiliations: APQ | MSE | RS