Moving from Compliance to Quality
Too narrow a focus on regulatory compliance may prevent organizations from embracing-and profiting from-quality and operational excellence.
Regulators and pharmaceutical manufacturers are debating the best way to measure quality. Discussions center on management and corporate cultures and how they impact operational excellence and customer-focused quality. Observers see the need for more proactive pharmaceutical company managers who actively support and invest in quality efforts and employee training.
Read this article in Pharmaceutical Technology’s December 2019 Regulatory Sourcebook.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook, December 2019
December 2019
Pages: 6–10
Citation
When referring to this article, please cite it as A. Shanley, “Moving from Compliance to Quality," Pharmaceutical Technology Regulatory Sourcebook eBook (December 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.
