QbD And Weighing: Ensuring Accurate Measurements

By Doug Dodridge

Weighing is a critical step in most pharmaceutical manufacturing processes and significantly impacts final product quality. The selection of the right weighing equipment depends on many factors and needs to be considered in any manufacturing approach based on the Quality by Design concept.

Incorrectly measured active ingredients included in a pharmaceutical formulation can lead to an out-of-specification batch that will need to be reworked or disposed of, adding extra labor and costs. It may even harm patients if not detected.

Quality by Design (QbD) is increasingly implemented in pharmaceutical manufacturing, driven by the need to improve final product quality and manufacturing process efficiency. QbD is strongly supported by regulatory authorities, such as the U.S. Food and Drug Administration (FDA) because it focuses the manufacturing process on consumer safety—from the beginning.

Quality by Design is a risk-based approach to integrating quality into the manufacturing process. Based on the defined target product quality, the entire manufacturing process is analyzed to identify material and process attributes that may influence product quality.

These critical quality attributes must be managed to ensure consistent product quality over time. Weighing has a critical impact on product quality. The weighing instrument not only needs to deliver accurate weighing results, it also must ensure consistent measurements over time in often challenging production environments. Furthermore, possible operating errors during the weighing process need to be identified and eliminated.

This white paper explains how you can proactively build sound weighing processes, based on Quality by Design, to ensure consistent quality of your products, improve productivity and reduce costs