Impact on Environmental Monitoring Programs for Clean Manufacturing

268-The-New-EU-GMP-Annex-1_Page_1.jpgThis updated document will set a milestone for adjustments needed within European agencies overseeing drug product's regulatory applications. 

During the writing of the draft, other international agencies participated and provided their feedback and thoughts, showing the critical need to have standardized regulations reflecting the true state of aseptic manufacturing. 

This paper provides a summary of the new aspects of environmental monitoring in sterile manufacturing and its probably implications to Pharmaceutical manufacturers.


Complete the form at the right to get the paper now.