Preparing for an FDA inspection is a serious part of running a pharmaceutical manufacturing facility. These inspections are done to check if your plant meets legal requirements and follows Good Manufacturing Practices (GMP). A successful inspection b
Practical Tips for Starting a Computerized Systems Validation (CSV) Project
Computerized Systems Validation (CSV) is a critical process in regulated industries like pharmaceuticals, biotech, and medical devices. It confirms that software and digital systems work as intended and meet all compliance requirements, especially th
How to Train Microbiology Lab Staff on cGMP Requirements: A Supervisor’s Guide
Training microbiology lab staff on current Good Manufacturing Practices (cGMP) is one of the most important tasks a supervisor can take on. Clean lab practices, proper documentation, and correct testing techniques are all part of protecting product q
Top cGMP Violations in Analytical Labs: FDA 483 and Warning Letter Trends
Analytical labs play a central role in drug development and manufacturing. Whether testing raw materials, finished products, or environmental samples, the accuracy and integrity of lab data are vital for patient safety and regulatory compliance. That
Hazard Communication in FDA Workplaces: A Role-Based Overview
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Avoid These Common Mistakes in Process Validation
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