News & Articles

A lot discussed topic is the new draft of Annex 1 “Manufacture of Sterile Medicinal Products” of the EU GMP Guide. This shall not be another analysis of the changes but a short reflection, which effects these changes would have on the selection of cleaning materials and specifically on cleanroom wip...

HACCP or Hazard Analysis and Critical Control Points 

Hazard Analysis and Critical Control Points and several Quality Management systems on a European level, food hygiene, and food safety have increased in importance over the years.

There are a few questions that we need to answer: 

However, wh...