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It is now established that validation is required for the manufacture of drug substances and drug products according to Good Manufacturing Practices (GMPs), for use in clinical trials and also to assure the data from preclinical studies conducted to Good Laboratory Practices (GLPs). The problem ...
Core principles: Both emphasize quality, consistency, and reliability in manufacturing. An emphasis on documentation and process validation is common. Regulatory oversight: Both sets of guidelines are overseen by similar regulatory bodies, like the U.S. Food & Drug Administration (FDA), U.S. Depar...
Gain insights into what the main building blocks are to a successful digital thread and how PLM is a key component. A portfolio of PLM solutions from PTC Get quick value from Windchill's standardized functionality, preconfigured best practices and built-in security with Windchill+, Arena's cloud...
The significance of rapid prototyping in manufacturing lies in its ability to quickly produce a physical object from a digital design. This capability is not just about speed; it also offers a tangible way to evaluate and refine a product’s design in the early stages, making the process more...
Gain insights into what the main building blocks are to a successful digital thread and how PLM is a key component. A portfolio of PLM solutions from PTC Get quick value from Windchill's standardized functionality, preconfigured best practices and built-in security with Windchill+, Arena's cloud...
Sustainability data, including the carbon footprint of manufacturing, distribution, and the item in use Why is product information important? Product information is crucial to every stakeholder in a product’s journey. From designers and manufacturers to commercial buyers, maintenance workers, and casual...
What is an MES? Manufacturing Execution Systems (MES) streamlines the manufacturing process, providing real-time data collection, monitoring, and control of production resources. These systems are pivotal components in today’s manufacturing landscape, bridging the gap between enterprise-level planning ...
Here products are manufactured in huge batches as opposed to continuously. There are many other production sectors that have been utilizing the continuous manufacturing method for years, yet the pharmaceutical sector stands out. It is because, without any wait times, the complete process happens in ...
GMP constitutes the license to operate in pharmaceutical manufacturing and is a core condition worldwide. However, rules and interpretations differ from country to country and change frequently. Therefore, having fully trained experts at hand to help with the implementation of these rules is very impo...