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While overall industry performance is trending positive, quality failures continue to negatively impact patients and the bio/pharma industry.
While patients generally trust that the drugs they take are safe, product recalls, drug shortages, reports of potential contaminants, and publicized regulatory enforcement actions can shake public confidence in the drug supply. While FDA looks to encourage voluntary compliance over the “stick” approach of tighter enforcement, biopharma companies are encouraged to build a quality culture throughout the organization, starting with top executives at the company.
eBook: Regulatory Sourcebook, September 2019
When referring to this article, please cite it as R. Peters, “Quality Culture Drives Patient Confidence in Drug Products," BioPharm International Regulatory Sourcebook eBook (September 2019).