The European Medicines Agency (EMA) is constantly adjusting its regulations, annexes, and guidances in responses to the needs of the industry, and the last 12 months have been no different. During this period they have issued a total of three revisions to established annexes and also issued a brand new guidance document in the GMP world. This article will focus on these four documents and describe what has changed and what it means to pharmaceutical companies.
Proportional valve technology in process automation offers a great a deal of flexibility and produces high-quality control results. A complete system supplied by Festo and installed in Boehringer Ingelheim's new technical centre demonstrates the performance that modern pneumatics can deliver. The project was developed in close communication between the Festo team and automation experts from the pharmaceutical company, allowing it to move forward quickly.
Today’s biotech and pharmaceutical production facilities must drive faster times to market and greater profitability for new products by boosting production yields and accelerating commercialization and scaling of capacity.
AstraZeneca is a global, science-led biopharmaceutical business. They are one of a handful of companies to span the entire life cycle of a medicine – from research and development to manufacturing and supply – as well as the global commercialization of primary care and specialty care medicines. Operating in more than 100 countries, AstraZeneca employs around 57,500 people worldwide. The company has manufacturing operations in 17 countries, and their innovative medicines are used by millions of patients worldwide.
As the demand for complex, portable medical devices continues to grow, reducing risk and increasing efficiency during the development of these products should be paramount.