Quality Culture

The Quality Culture can be defined as "The collective attitudes, beliefs and behaviors of an organization and of individuals in the organization related to delivering quality pharmaceutical products to the patient."

The ISPE 6 Dimensions of the Quality Framework

Improving the Quality Culture

The Quality Culture of an company in a regulated environment is forming the basis which drives the overall QA Compliance of an enterprise and the way an organization operates, striving for delivering safe, effective and compliant product to patients. A good Quality Culture requires accountability by management, well defined processes, Quality metrics, continuous improvement, risk based decision making, and Values that are based on trust and open communication. PRO Pharma Consulting can support strengthening the Quality Culture through:

  • Assessment of the status of the Quality Culture through workshops and interviews
  • Proposing actions to improve the Quality Culture
  • Implementing selected elements to strengthen the Quality Culture