Foreign facilities failed FDA GMP inspections at up to 1.8x the U.S. rate. Journal of Pharmaceutical Innovation study ...
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 ...
SUZHOU, China, May 21, 2025 /PRNewswire/ -- BioDlink has achieved a significant milestone in regulatory compliance after successfully passing an on-site GMP inspection conducted by Brazil's National ...
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 ...
The success of virtual GMP inspections performed during the pandemic may lead to more flexible opportunities in the future. A temporary system, under which good manufacturing practice (GMP) ...
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 ...
Alkem Laboratories announced that it has received a Certificate of GMP (Good Manufacturing Practice) Compliance of a Manufacturer from the Department of Pharmacy (Human Medicines), Germany for its ...
PETACH TIKVA, Israel, Sept. 16, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced ...
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 ...