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Outsourcing Quality Assurance

October 23, 2013 Leave a comment Go to comments

One of my colleagues in the pharma industry asked a question the other day if Quality Assurance could be outsourced. Here’s the answer:

“This is an acceptable practice, and has precedent in the pharma/biotech industry. It must be managed and controlled like any outsourced process as described in ICH Q10. Pretty much everything can be outsourced except Management Responsibilities (again, an ICHQ10 requirement). This is how virtual companies, integrators, and specification developers often run their QA. Don’t believe that outsourcing QA will protect the Management team: Management still has overall responsibility for quality outcomes, including quality of product on the market. Think of the European model of Qualified Persons; they often act on an independent contract basis. A strong quality/technical agreement that describes the scope, responsibilities, and oversights how this outsourced process is managed would be the first step in outsourcing QA.”

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