Meeting Summary

        by Mike Bradley

Strategies for Successful Implementation of Process Analytical Technologies (PAT) in Pharmaceutical Manufacturing

Walter Dziki from Abbott Laboratories spoke to the SAS Chicago Section on “Strategies for Successful Implementation of PAT in Pharmaceutical Manufacturing.” Twenty-one people from the section attended.

Walter presented information first about the impact of PAT. In short, PAT is a system for designing, analyzing and controlling manufacturing – rather than relying upon an analysis of the finished product. Key to this is the information management of timely measurements – determining if blenders, reactors and dosage preparation are proceeding optimally. The FDA is interested in PAT as a way to test and control processes to save both the FDA and the manufacturer efforts.

Walter then discussed implementation, through identifying Process Critical Control Parameters, and the analytical and control technologies (PaT and PcT) needed. Typical methods used are near-IR (most common), mid-IR, Raman, Thermal effusivity and Laser-induced fluorescence. Implementation then proceeds by 10 steps, starting with team formation and identification of a “PAT Champion” responsible for educating the PAT Team on the different components of PAT. Step 10 involves training and instruction of line operators, and examination of potential problems by involved scientists and engineers.

Walter’s key conclusions were that PAT is used to gain process understanding, and that PAT testing will be used for that understanding and will NOT impact product status as long as the product meets release specs. PAT will only work with management support and when PAT becomes a full part of the business model. PAT requires a broad-based team, and education of the goals.

The questions centered on implementation issues. Walter noted that PAT will allow processes to be changed with more flexibility (production is rigidly monitored now) – essentially, PAT will allow improvements that don’t affect final product quality to be implemented. On the whole, Walter concludes, both the industry and the FDA will benefit from PAT implementation.