Quality

Is about developing and implementing systems to ensure that medicines are manufactured to the highest quality.

People working in Quality roles are responsible for developing and implementing systems to ensure that medicines are manufactured to the high quality expected and that the final products satisfy the quality aspects of the regulatory requirements relating to them. The Quality function ensures that quality is built in to the medicine by adherence to proper manufacturing procedures rather than just relying on testing the product at the end of the process. 

The final responsibility for certifying that a batch of medicine meets its specifications lies with the Qualified Person (QP), however he, or she, relies on support from a team of people with specific responsibilities for Manufacturing Quality Control,and Quality Assurance.

• Quality Control
• Quality Assurance