Quality by Design – How Weighing Contributes
For many, quality control means checking final products once they are complete to ensure they fulfill specified attributes. Building quality into the manufacturing process by design, however, helps to ensure even complex weighing processes meet quality goals, especially in highly regulated environments such as the Pharmaceutical Industry.
Active ingredient weighing tolerances can be as low as several thousandths of a percent in pharmaceutical manufacturing. With expensive or rare ingredients – and even lives – on the line, errors can be costly, especially if they are not discovered until the end of a batch process.
Quality by Design
Quality by Design (QbD), a scientific, risk-based approach to quality, is increasingly being adopted in pharmaceutical manufacturing. Supported worldwide by regulatory agencies such as the U.S. Food and Drug Administration, QbD focuses pharmaceutical manufacturing on quality from the very beginning of process design.
Weighing Process Understanding
Weighing plays an important role in the pharmaceutical manufacturing process. A weighing instrument must deliver accurate results and ensure consistency over time, often in challenging environments.
A full understanding of the weighing process will form a critical basis not only for equipment selection but for determining how often weighing equipment should be maintained. It will also determine how stringent operator training and standard operating procedures should be to ensure process accuracy.
Weighing equipment selection is grounded in an understanding of the manufacturing process, taking the following equipment aspects into account:
- The accuracy of the weighing sensor meets process tolerances.
- The equipment is designed for rough manufacturing and harsh cleaning conditions.
- The equipment is easy to use and provides appropriate operator guidance.
Taken together, these aspects should lead to the selection of weighing equipment matched to the needs of the manufacturing process.
Installation and Maintenance
Qualification and validation methods help ensure consistent process accuracy and safe data management. Calibration must be conducted by qualified personnel on site and the equipment must be re-calibrated at regular intervals to ensure accurate results. The weighing process, plus routine testing and cleaning procedures, need to be defined in standard operating procedures to ensure correct utilization and reliable performance of the weighing equipment.
Good Weighing Practice
METTLER TOLEDO has developed Good Weighing Practice™ (GWP®) as a standardized scientific methodology for secure selection, calibration and operation of weighing equipment. GWP® can help pharmaceutical manufacturers meet QbD goals, protecting both consumers and company reputation in the process.
Learn more about GWP:
Free webinar on QbD and Weighing
Weighing influences product quality and must be considered in Quality by Design (QbD) processes. Learn more about how weighing solutions support QbD principles in pharmaceutical manufacturing.
Visit METTLER TOLEDO’s free, on-demand webinar:
