When they closed the plant, the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) cited bacterial contamination in some lots of vaccine, and a failure to follow good manufacturing ...

With over 15 years of expertise in developing injectable and liquid pharmaceutical forms, CARBOGEN AMCIS’ Saint-Beauzire site provides tailored solutions for pre-clinical and clinical trials and small ...

Discover why pharmaceutical-grade supplements command premium prices and whether their higher standards of purity, potency ...

"This warning letter summarises significant deviations from Current Good Manufacturing Practice (CGMP) for APIs. Because the methods, facilities, or controls for manufacturing, processing ...

Photo courtesy DPR Construction All of this is in service of keeping the facility to the stringent requirements of the U.S. Food and Drug Administration’s Current Good Manufacturing Practice ...

The stringent action is meant to prevent criticism of quality of drugs produced in the country and to prevent any non-tariff ...

But only 2,000 of them have the World Health Organization’s (WHO) good manufacturing practice certificate. The scheme was launched last year for pharma companies to modernize their units after a ...

These include the operation and maintenance of processing facilities, complying with the codes of current good manufacturing practices, ensuring effective quality assurance and quality control systems ...

The Rosenberg facility enhancements will accommodate increased production volumes while ensuring compliance with FDA regulations and current good manufacturing practices (cGMP). The site will ...