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 ...

"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 ...

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 ...

all carried out in fully inspected and certified facilities in accordance with good manufacturing practice (GMP). Biovian has long experience with manufacturing viral products, and, owing to the ...

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

This is the first inspection of a routine process by ANSM to ensure compliance with Good Manufacturing Practices (GMP). As a result, CARBOGEN AMCIS has been granted a GMP certificate for the ...

Micro, small and medium enterprises (MSMEs) with revenue of less than ₹ 250 crore have to submit an application before the ...