GMP Update - what was new in 2016?

"You get the impression that GMP is developing faster and faster". During the past year, the world of GMP turned somewhat slower. Its developments in the GMP environment remain interesting though.


IMDRF publishes Guidance Draft on Clinical Studies with Software as a Medical Device

The IMDRF (International Medical Devices Regulator Forum) is the successor organisation of the Global Harmonisation Task Force (GHTF). Recently, the IMDRF has published a guidance draft entitled "Software as a medical Device (SAMD): Clinical Evaulation".


FDA's Plans with regard to Medical Devices in 2017

What the FDA plans with regard to the regulation of medical devices can be found in a report on Regulatory Science Priorities.


FDA's Current Publications for Manufacturers of Medical Devices

In irregular intervals, the ECA publishes overviews over new guidances or draft guidances, webinars, general strategy papers and inspection outcomes of the FDA with regard to medical devices. Find out more in the selection of FDA publications of the last months.


Warning Letter and Import Alert for Chinese Manufacturer

During an FDA inspection of a Chinese drug manufacturer, the inspector criticized serious and sometimes even bizarre GMP violations  Read more about the Warning Letter to the Chinese Manufacturer Baoying County Fukang Medical Appliance Co. Ltd.


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