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Production and process controls, organization and personnel were the top problems found, while packaging and labeling citations increased in 2017 and 2018.
An analysis of from Form 483 observations issued by FDA during routine investigations of finished drug and API manufacturing sites provide pharmaceutical quality compliance professionals, managers, and operators with insights into how they can best strengthen compliance and develop appropriate solutions for key regulatory compliance issues.
eBook: Regulatory Sourcebook, December 2019
When referring to this article, please cite it as A. Shanley, “Moving from Compliance to Quality," BioPharm International Regulatory Sourcebook eBook (December 2019).