quality-risk qrm-tools 
European Pharmaceutical Review
AUGUST 25, 2023
The new guideline should help manufacturers gain clarity on how to benefit from new possibilities originating from the application of an enhanced process understanding by utilising innovative tools as described in the ICH guidelines Q9 and Q10. The former ICH guideline came into force on 26 July 2023.
European Pharmaceutical Review
JANUARY 16, 2023
“Connectivity between the laboratory and manufacturing facility is growing, and the use of digital tools will continue to build that integration,” commented Miriam Guest. All require aseptic manipulation, hence have microbial contamination risks. The FDA is doing this through the publications of Guidance for Industry.
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