Ensuring compliance with weighing-related regulations in pharma manufacturing

WEIGHING applications in pharmaceutical manufacturing have a strong influence on the quality of the final product, but it is the responsibility of the manufacturer to interpret these guidelines and assess process risks accurately to ensure consistent weighing performance quality. While the pharmaceutical industry is one of the most regulated, there may not be enough specificity since regulatory frameworks such as Good Manufacturing Practices (GMP) usually provide only broad guidance.

 

Carefully selecting a weighing solution to match specific process requirements is critical in pharmaceutical manufacturing because weighing processes contribute significantly to consistent final product quality. It is also essential to establish regular calibration and routine testing schedules to ensure accurate measurements over time. These and other requirements clearly are stated by regulations such as GMP. But those regulations do not provide specific instructions on how to select the right weighing instrument and what interval would be best suited to ensure consistent measurement accuracy. It is left to the pharmaceutical company to specify process requirements, ensure the right equipment is selected and installed and implement a suitable calibration and testing strategy.

 

To assist manufacturers, Mettler-Toledo experts have created a new on-demand webinar, “Regulatory Compliance – Weighing in Pharmaceutical Manufacturing,” that provides a comprehensive overview of weighing-related regulations and explains how to ensure compliant weighing processes.

 

The 30-minute on-demand webinar examines the implications of those regulations on weighing systems along the entire product lifecycle, including design, selection, installation, calibration, performance and maintenance of weighing systems. Finally, the white paper provides guidance on how to utilize the global weighing standard GWP® (Good Weighing Practice™) for efficient lifecycle management of weighing systems. GWP helps to reduce measurement errors and to ensure reproducibly accurate weighing results. In addition, GWP provides documented proof that the weighing system complies with regulatory requirements and quality standards.