Lessons from FDA 483s and cGMP Inspection Data

Author(s)Ajay Pazhayattil, Naheed Sayeed, Marzena Ingram

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.

Read this article in BioPharm International’s December 2019 Regulatory Sourcebook.

Article Details

BioPharm International
eBook: Regulatory Sourcebook, December 2019
December 2019
Pages: 6–9

Citation

When referring to this article, please cite it as A. Shanley, “Moving from Compliance to Quality," BioPharm International Regulatory Sourcebook eBook (December 2019).

Articles in this issue

almost 6 years ago

Article

Revision Process for Global/National Pharmacopoeias (eBook)

almost 6 years ago

Article

Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions (eBook)

almost 6 years ago

Article

Warning Letters Signal Steps to Compliance

almost 6 years ago

Article

Resources, Guidelines, and Guidance Documents

almost 6 years ago

Article

Regulatory and Standard Setting Organizations

almost 6 years ago

Article

Quality Risk Management Plans Create Effective Quality Systems

Newsletter

Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.

Subscribe Now!