Mettler Toledo has published a new white paper explaining the relevance of standards and regulations on weighing application in pharmaceutical manufacturing
Weighing applications in pharmaceutical manufacturing can strongly influence the quality of the final product. However, while the pharmaceutical industry is one of the most regulated, regulatory frameworks such as Good Manufacturing Practices (GMP) usually provide only broad guidance. It is the responsibility of the manufacturer to interpret these guidelines and assess process risks accurately to ensure consistent weighing performance quality. Mettler Toledo experts have created a new white paper, 'Regulatory Compliance – Weighing in Pharma Manufacturing', that provides a comprehensive overview of weighing-related standards and regulations for pharmaceutical manufacturing.
Carefully selecting a weighing solution to match specific process requirements is critical in pharmaceutical manufacturing because weighing processes can contribute significantly to consistent final product quality. Furthermore, it is 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, Pharmacopoeia and ISO.
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.
The free white paper 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 utilise 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. And finally, GWP provides documented proof that the weighing system complies with regulatory requirements and quality standards.Download the white paper