Umetrics is happy to announce the release of our QAP software (Quick Analytical Predictor) as part of our PAT suite for Pharmaceutical Manufacturing.

QAP reads data in real time from any instrument, sensor array or data base, and simultaneously handles several data sources. The data profile is compared with a multivariate process model developed in SIMCA-P(+), to give immediate answers displayed on the Web an/or written back to an OPC process historian for further analysis, e.g., by SBOL of Umetrics, for an overall determination of the batch quality.

Hence QAP provides a standard multivariate data evaluation platform for a pharmaceutical company, from R&D to manufacturing. This platform is common for any application, validated *, and 21CFR11 compliant *.

QAP benefits include:
• Reducing validation costs for PAT devices
• Minimizing deployment time for PAT technology
• Improving PAT system robustness
• Reducing customized interface code 

In pharmaceutical manufacturing, QAP reads real time spectral or/and other data profiles relating to a step in a primary or secondary pharmaceutical manufacturing process. This could be an API synthesis, formulation blending, granulation, drying, tablet compacting, or coating. The result may be the determination of one or several concentrations in an intermediate or in the final product such as API concentration, humidity, or impurities, or other quality measures such as average particle size, uniformity, coating thickness, or color. Any determination comes with a confidence interval (95 or 99 %).

Other application areas include manufacturing in the chemical, pulp and paper, food and beverages, cosmetics and consumer products industries.

QAP can also perform a classification of the profile as indicating, e.g., “in spec” or not, also with a probability of correctness. A third typical application is end-point detection using on-line spectroscopy, e.g., in a blending or drying operation.

More details about QAP will soon appear on this Web-site.

“QAP gives our customers a validated and 21CFR11 compliant module in our PAT suite that monitors one unit operation in real time, as well as applying during process development. This provides a rapid efficient way to get PAT up and running on critical steps of the manufacturing process” says Nouna Kettaneh, General Manager of Umetrics. 
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* in progress