EU and US regulators are striving to work together on improving GMP inspection efficiencies and avoiding duplication of efforts. The European network of medicines regulatory agencies, co-ordinated by ...

The European Union is collaborating with the Pharmaceutical Inspection Co-operation Scheme to develop similar guides for evaluating inspectorates’ competency. The European Union’s medicines agencies, ...

WUXI, China, Oct. 27, 2021 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced that it has completed a remote GMP ...

The Dutch authority carrying out GMP inspections, the Health and Youth Care Inspectorate (IGJ), announced it will carry out a series of pilot inspections focussing on the validation of computerised ...

On 4 March 2017, the agreement between the EU and the US governing the reciprocal recognition of GMP inspections of manufacturing sites for medicinal products for human use was published in the ...

It is very important for pharmaceutical companies to plan carefully for all Good Manufacturing Practice (GMP) inspections, as a successful outcome is required for continued operations. Careful ...

The agency hopes to better use global resources and avoid duplicate inspections of foreign facilities. The need to inspect a growing volume of overseas pharmaceutical manufacturers, but limited FDA ...

WUXI, China, Feb. 27, 2025 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that it has ...

WUXI, China, April 6, 2021 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, today announced that it has successfully ...