This article provides an overview of the regulatory guidelines and the fundamental GMP requirements with regards sterile manufacturing of medicinal products, with a particular focus on engineering aspects.
How a proactive approach involving predictive — rather than preventive — tools to identify deficiencies before they compound and become actual problems can result in a healthy bioprocessing facility.
Changing and creating documentation involves many disciplines and long lead times. This case study explains how to improve Global Documentation Change Control Processes quickly and easily.
Current market conditions such as regulations and mergers or acquisitions make improving compliance and manufacturing efficiency while driving to grow revenue and margins difficult. Read on to understand strategies, frameworks and recommendations to achieve these goals.
A platform’s integrated business framework helps dental implant and medical device manufacturer eliminate traditionally disconnected processes and data and increase the efficiency and accuracy of its product quality control.
With the importance of monitoring and verifying pressure conditions as well as humidity and temperature measurement data in its cleanrooms, this automation, management and monitoring solution offered a consistent solution for technical facility management and thus the prerequisite for cost-optimized plant operation.
Density measurement is a powerful and important method to ensure in-process control (IPC) and quality control of final products in pharmaceutical production facilities.
Using workflow based software solutions to guide scientists through various processes in low to high throughput screening campaigns.
This webinar explores some use cases to show how machine learning and Big Data analytics can help overcome the challenges facing the biopharmaceutical industry through more confident data-driven decisions.
Striving to bring the way we acquire, share and gain insights from scientific data, through a community and the framework for standardization and linked data.
Very few new molecular entities in active clinical development are readily bioavailable, and when dosed at escalated levels, even these may not be sufficiently absorbed. Learn how spray-dried amorphous dispersion might help.