White Paper: Achieving PAT Goals With Process Analytics Equipment

Pharmaceutical manufacturers need to focus on quality and cost efficiency. Traditionally, the pharmaceutical industry evaluates quality on samples tested in the laboratory. The FDA has encouraged the industry to implement in-line tools as described in the PAT initiative, with the goal being to better understand and control the manufacturing process.

In 2002, the FDA in recognition of the need to alter the pharmaceutical industry's belief, launched a new initiative called "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach." This scheme has led to the FDA encouraging the adoption of Process Analytical Technology (PAT) tools, with the goal being for pharmaceutical companies to better "understand and control the manufacturing process" (http://www.fda.gov/Cder/ OPS/PAT.htm). These PAT techniques include continuous improvement and knowledge management tools, and data acquisition and analysis tools.