The importance of meeting Supplier Management criteria

Meeting the supplier management criteria set out by the FDA, the ISO and the QSR regulations is mandatory for the regulated industries. The qualification and assessment of suppliers is binding for the regulated industries. Being in compliance with the requirements for supplier management set out by the FDA and by the ISO and QSR standards […]

Quality by Design using Design of Experiments 2017

The ICH has offered further guidance and policies for explaining the ways by which the QbD approach should be integrated into the pharmaceutical Quality System