By: IPP Bureau
Last updated : May 07, 2026 9:24 am
Successful inspection outcome strengthens company’s regulatory compliance and manufacturing standards in China
CARBOGEN AMCIS, a Switzerland-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced that its Shanghai facility successfully completed an unannounced Good Manufacturing Practice (GMP) inspection by China’s National Medical Products Administration (NMPA), with no observations.
The inspection, conducted on 14 April 2026, included a comprehensive on-site assessment of API manufacturing operations and the site’s Quality System. As part of the unannounced inspection, NMPA inspectors reviewed manufacturing processes, facilities, quality control laboratories, documentation practices and overall quality management systems.
The inspection concluded with no critical, major or minor observations. Inspectors also confirmed that no issues requiring formal explanation were identified at the close of the inspection. Recommendations were provided to support ongoing continuous improvement.
“This outcome reflects the high level of preparedness and expertise demonstrated by our Shanghai team, as well as the strength and maturity of our Quality System,” said Stephanie Schlienger, V.P. Quality & Compliance, of CARBOGEN AMCIS. “The successful completion of an unannounced inspection with no observations underlines our commitment to maintaining the highest GMP standards across all aspects of our operations.”
Stephan Fritschi, CEO of CARBOGEN AMCIS, added: “Successfully completing an unannounced NMPA inspection with no observations is a significant achievement and a strong validation of our global quality culture. It demonstrates our ability to consistently meet rigorous regulatory expectations and reinforces confidence in our Shanghai site as a reliable partner for our customers worldwide.”