Inspection

Criteria of Maintaining Audit and Inspection Readiness in Pharmaceutical Industry

Criteria of Maintaining Audit and Inspection Readiness in Pharmaceutical Industry

ByPharma Digest

To maintain audit and inspection readiness at all times in pharmaceutical industry, following criteria are to be maintained: 1. Clear Communication Channel 2. Document Control and Management 3. Effective Training and Competency Programs 4. Robust Change Control Processes 5. Real-time Monitoring and Data Analytics 6. A Culture of Continuous Improvement To do this, create goals…

FDA Findings and Remdies on cGMP Violations

FDA Findings and Remdies on cGMP Violations

ByPharma Digest

The U.S. Food and Drug Administration (FDA) recently inspected a US drug manufacturing facility and identified several significant cGMP violations, resulting in a Warning Letter (#649198). The violations include: Here are five remediation actions that the company should take: Cleaning and Maintenance Procedures: Investigations and Deviations: Production and Process Control Procedures: Contamination Prevention: Independent Assessment:…