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 ...

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

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

The government revised Schedule M under the Drugs & Cosmetic Act in 2023 to make it mandatory for companies to follow Good ...

By utilizing the best practices below, business leaders can address critical issues and leverage AI to expand human potential and make manufacturing jobs more attractive and fulfilling for the ...

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 ...

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

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 ...

Texas that meets the FDA’s current good manufacturing practices (cGMP) for viral gene therapies. FUJIFILM Diosynth Biotechnologies operates Biosafety level 2 mobile clean rooms that are ...

Aveo Pharmaceuticals asserts that a stop-production notice was issued due to non-compliance with GMP standards, not for ...

USFDA warning letter to Granules India for facility contamination and CGMP violations, prompting corrective action and ...