Part 1 dealt with the management perception that cGMPs are not relevant to the business, and it laid out the defense that cGMPs enable a predictable quality outcome that serves the business and its patients very well.
In Part 2, the quality function was indicated to be in the best position to make the defense of the relevance, but all too often it has problems of its own and should be the focus of serious organization development.
In Part 3, it was recognized that although management may be responsible for the quality system, they may not know how to exercise that responsibility. It is the responsibility of the quality unit to provide a forum where management can make data-driven decisions and monitor quality system performance.
- Use the established quality management review and governance processes to identify cGMP highly leveraged improvement targets as site-wide objectives.
- Partner with operations functions to develop mutually beneficial objectives.
- Manage the work and remove impediments.
- Reward results, not the process.
The QA Pharm
The QA Pharm is a service of John Snyder & Company, Inc.
John Snyder & Company, Inc., provides consulting services to companies regulated by the Food and Drug Administration. We help our clients to build an effective Quality Management System to enable reliable supply of quality products to their patients. We also help our clients to develop corrective action plans to address regulatory compliance observations and communication strategies to protect against accelerated enforcement action.
Contact us at firstname.lastname@example.org.