Good Manufacturing Practices (GMP): FDA Citations and Warning Letters... Lessons Learned

Organization: Knowledge Essentials

Created by: Knowledge Team


Good Manufacturing Practices (GMP): FDA Citations and Warning Letters Course



The United States Food and Drug Administration (USFDA) conducts inspections of pharmaceutical manufacturing facilities worldwide to ensure compliance with current Good Manufacturing Practice (cGMP) standards. These inspections cover facilities that produce both active ingredients and finished products. Failure to comply with cGMP regulations renders any drugs manufactured by a company “adulterated” under the law, indicating they were not produced in accordance with cGMP conditions.

In recent years, the FDA has escalated enforcement actions, issuing warning letters, import alerts, and seizures to manufacturers found violating cGMP regulations. This course focuses on analyzing Specific Warning Letters issued by the USFDA as case studies, examining non-compliance with 21 CFR 210 and 21 CFR 211 inspection systems.

The Good Manufacturing Practice (cGMP) refresher course elaborates on the fundamental and current requirements of global GMP guidelines. It delves into the essential prerequisites for all GMP-regulated activities subject to FDA inspection, analyzing recent trends from FDA inspection reports and enforcement actions.

Additionally, the course provides insights into how GMP personnel can monitor industry practices to stay up to date with FDA requirements. By extracting lessons from various warning letters, the course guides participants in developing a robust compliance regimen tailored to address repetitive GMP errors effectively.

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