Quality Culture Drives Patient Confidence in Drug Products
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, bio/pharma companies are encouraged to build a quality culture throughout the organization, starting with top executives at the company.
Read this article in Pharmaceutical Technology’s September 2019 Regulatory Sourcebook.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook, September 2019
September 2019
Pages: 4–5
Citation
When referring to this article, please cite it as R. Peters, “Quality Culture Drives Patient Confidence in Drug Products," Pharmaceutical Technology Regulatory Sourcebook eBook (September 2019).
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
