As described in this guidance, the Quality Systems Model is meant to help manufacturers achieve compliance with CGMP
regulations. If properly implemented, the model can provide a manufacturer the controls it needs to consistently make a
product of acceptable quality. Many quality system elements correlate closely with CGMP regulations. The QS Model is divided
into four sections: management responsibilities, resources, manufacturing operations, and evaluation activities. Under each
section, key elements that can help a manufacturer achieve a robust modern QS Model are described.
