|Articles|December 15, 2019
- BioPharm International-12-15-2019
- Volume 2019 eBook
- Issue 5
Warning Letters Signal Steps to Compliance
Author(s)Rita C. Peters
Warning letters tell the tale of missteps by drug companies and offer a path to compliance for quality teams that monitor these enforcement actions.
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While the number of warning letters issued by FDA has declined slightly, recurrent violations include poorly maintained equipment and facilities, insufficient cleaning validation, inadequate written procedures for quality testing, and inadequate controls over data and computer systems. Effective, ongoing monitoring programs-for regulatory agency enforcement actions and pharmacopoeia updates-are essential for bio/pharma compliance.
Article Details
BioPharm International
eBook: Regulatory Sourcebook, December 2019
December 2019
Pages: 3–4
Citation
When referring to this article, please cite it as R. Peters, “Warning Letters Signal Steps to Compliance," BioPharm International Regulatory Sourcebook eBook (December 2019).
Articles in this issue
almost 6 years ago
Revision Process for Global/National Pharmacopoeias (eBook)almost 6 years ago
Lessons from FDA 483s and cGMP Inspection Dataalmost 6 years ago
Resources, Guidelines, and Guidance Documentsalmost 6 years ago
Regulatory and Standard Setting Organizationsalmost 6 years ago
Quality Risk Management Plans Create Effective Quality SystemsNewsletter
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