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, 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.
But management oversight can still be handicapped if there are no governing bodies or processes to communicate regulatory compliance and product quality risks.
- There is a network of quality officers that represent each level of the company.
- A process and criteria are established to rapidly communicate critical issues.
- Key quality metrics of importance to the corporate network are established.
- The corporation supports an Ombudsman program.
The QA Pharm
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.