FDA

New FDA Food Safety Modernization Act (FSMA) Rules Published

The U.S. Food and Drug Administration (FDA) has made two final Food Safety Modernization Act (FSMA) rules public: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals JDSupra Business Advisor published an article discussing an overview of…

Dr. Sandle

Dr. Sandle on Cleanrooms & Contamination

For pharmaceutical manufacturers, hospitals and other facilities that contain cleanroom technology, the risk of contamination can be avoided by implementing proper environmental controls. These controls range from efficient cleanroom design to implementing gowning procedures. A full, detailed article on what you can do at your facility to maintain workplace safety and prevent contamination is available…

Compliance

What is Validation?

There are three commonly used types of validation protocols for systems and equipment: Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) IQ protocols should be designed to: Record critical information applicable to the equipment, including equipment attributes such as the manufacturer, serial number, model number, equipment tag or asset number, materials of construction, and…