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Value: License to Operate Pharma, Biotech, Med Devices

What Is My License to Operate (LTO) Worth?

Quality Management - 26 August 2015

The Life Sciences industry has a history of heavy regulation. Whether your company markets pharmaceutical, biotechnology or medical device products, maintaining your License to Operate (LTO) is an absolute necessity. You have an obligation to your customers to manufacture and market high quality, safe and effective products.

Obtaining approval of a marketing application, passing all subsequent regulatory inspections and manufacturing quality products that meet your customers’ expectations requires dedicated and highly skilled people, well-designed and maintained facilities and a compliant Quality System.

In today’s regulated environment, the GxP expectation is that the Quality System is automated. To meet that expectation in a cost-effective and efficient manner means having an Enterprise Quality Management System (EQMS). The tracking, trending, reporting, and communication of quality and compliance issues cannot be done effectively without an EQMS.

What is the real cost if a customer is harmed by one of your products? What is the cost of a recall? What if the product is not available for the patient who depends on it? What is the cost of a Warning Letter? What is the cost of a delay in the next new product’s approval and launch? What if the company comes under a Consent Decree? Everything can be lost! Not only is the company impacted, but there can also be personal liability. Individuals can be discharged, debarred, fined and even go to jail.

So ask yourself: What is my License to Operate worth? The investment in an EQMS is a small price to pay, compared to all that is at stake.


About the Author
Brian Graeff is currently the Head of the Quality Best Practices Unit at SOLABS. Brian’s career in the pharmaceutical industry spans over 40 years during which he held various management positions in Quality Assurance, Quality Control and Production with Sterling Drug-Winthrop Laboratories, AstraZeneca, and Sunovion Pharmaceuticals Inc.. Brian retired from Sunovion in 2010, where he served as the VP of Quality Operations. During his career, Brian helped manage many different drug products and API’s with the majority of his experience being with parenteral, respiratory and tablet dosage forms. Brian brings a wealth of experience in pharmaceutical manufacturing, quality management, FDA interactions and CGMP interpretation and implementation to the table.

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