Our guidelines
Quality by Design (ICH Q8 – 10)
ICH Q9
Toolbox
ICH Q9
Toolbox


ICH Q10
conduct commercial
manufacturing


ICH Q10
Process Change
controls


ICH Q10
respond to
deviations


ICH Q10
improve products
and processes


ICH Q8
develop new
Products (QBD)


ICH Q8
develop new
ProCESS


ICH Q8
TECH TRANSFER


ICH Q10
QUALIFY AND
Validate product
and Process