Particle Measuring Systems (PMS) news
Stem cell therapy is a groundbreaking field in the pharmaceutical industry, offering powerful tools for treating severe diseases such as cancer. The genetic manipulations involved in this process, however, necessitate stringent regulations to ensure sterility and safety. In 2017, the Food and Drug Administration (FDA) took significant steps towards regulating stem cell therapy, marking a pivotal moment in the industry. Thi
The role of quality systems in pharmaceutical organizations has grown faster than any other function during the last 15 years. During this period, a small group dedicated to traditional Compliance grew and expanded to include Quality Experts in areas such as validation, product release, operations, sterility assurance, and other specialized functions. Creating a deeper quality connection between manufacturing and engineering has always been the aim of that growth. Little by little, qual
The Italian Biochemical Institute (IBI) “Lrenzini”, Comecer, and Particle Measuring Systems (PMS) recently partnered to leverage and combine the expertise of each entity to design a new drug delivery system and a filling line to safely and effectively manufacture it. A Quality Risk Management (QRM) approach was used as the basis to meet the distinctive needs of the aseptic filling line and ensure
Particle Measuring Systems (PMS) and Novatek International have partnered to create the first fully integrated cleanroom data management system, PharmaIntegrity, to securely meet regulatory requirements and ensure product integrity. This combination allows pharmaceutical manufactures to quickly and easily set up a fully integrated cleanroom monitoring and data management system.
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