Our quarter horses are well-watered because of established roles and responsibilities around the ranch. But I am no longer surprised that in the pharma industry it's not that easy to point to who is responsible for what when it comes to the details of the quality management system.
I typically get one of two responses to the question, "Who owns the [fill in the blank] system?" Whether it is Training and Qualification, Deviation and CAPA, Document Management, Complaint Handling--or whatever-- it's the same:
- Ultimately it is the Head of Quality, or
- What do you mean "own" (or responsible) exactly?
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.