The implementation of the new European Pharmaceutical Directive (2004/27) have come into force on October 30, 2005. After that, each Active Pharmaceutical Ingredient will have to follow Good Manufacturing Practices according to the International ICHQ7A reference system. Roquette is therefore preparing to apply this quality reference system to its active ingredients.

For more information on this issue, please contact us or your local representative.

Other questions - Quality Status

What documentation is available for the CTD (Common Technical Document)?

See answer