BUBENDORF, Switzerland, May 6, 2026
CARBOGEN AMCIS, a global pharmaceutical process development and active pharmaceutical ingredient (API) manufacturing company, has announced the successful completion of an unannounced Good Manufacturing Practice (GMP) inspection at its Shanghai manufacturing facility conducted by China’s National Medical Products Administration (NMPA). The inspection concluded with no observations identified, reinforcing the company’s commitment to maintaining high-quality pharmaceutical manufacturing standards and strong regulatory compliance across its global operations.
The inspection was carried out on April 14, 2026, and included a comprehensive evaluation of the site’s API manufacturing operations, quality systems, documentation procedures, laboratory controls, and facility management practices. According to the company, NMPA inspectors reviewed all major operational and compliance functions associated with pharmaceutical manufacturing and quality assurance processes. The successful inspection outcome is considered a major achievement for the Shanghai site, particularly because the audit was conducted without prior notice under routine operating conditions.
NMPA Inspection Confirms Strong GMP Compliance Standards
CARBOGEN AMCIS stated that the NMPA inspection assessed the Shanghai site’s ability to consistently maintain compliance with international GMP standards across its pharmaceutical production activities. Inspectors examined manufacturing workflows, quality control laboratories, data management procedures, equipment maintenance systems, and overall quality governance frameworks to ensure regulatory expectations were met throughout the facility.
The inspection concluded without any formal observations or deficiencies requiring corrective action, demonstrating the operational readiness and quality management maturity of the Shanghai manufacturing site. While inspectors provided recommendations supporting continuous improvement initiatives, the company confirmed that no major compliance concerns were identified during the review process.
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Stephanie Schlienger, Vice President of Quality & Compliance at CARBOGEN AMCIS, stated that the successful inspection outcome reflects the expertise, preparedness, and operational discipline maintained by the Shanghai team. She emphasized that completing an unannounced GMP inspection with no observations validates the strength of the company’s quality systems and highlights its ongoing commitment to maintaining the highest standards in pharmaceutical manufacturing and regulatory compliance.
Shanghai Facility Supports Global API Manufacturing Operations
The Shanghai facility serves as an important component of CARBOGEN AMCIS’ global pharmaceutical manufacturing network, supporting both API production and pharmaceutical process development activities for customers across international markets. The company noted that maintaining compliance with Chinese regulatory authorities is critical for supporting continued expansion within Asia’s rapidly growing pharmaceutical manufacturing sector.
According to the company, the inspection outcome strengthens confidence in the Shanghai site’s ability to deliver high-quality pharmaceutical manufacturing services aligned with evolving international regulatory expectations. The facility plays a strategic role in supporting customers operating across pharmaceutical and biopharmaceutical development programs requiring compliant API manufacturing capabilities.
Simone Maggi, Site Quality Head at CARBOGEN AMCIS Shanghai, highlighted the significance of the inspection’s unannounced nature, explaining that surprise regulatory audits evaluate how effectively systems operate under normal routine conditions rather than under specially prepared circumstances. He stated that the successful outcome demonstrates the consistency of GMP execution throughout the site while validating the competence and readiness of the local operational teams.
Regulatory Success Reinforces Global Quality Strategy
CARBOGEN AMCIS CEO Stephan Fritschi described the successful NMPA inspection as a significant validation of the company’s global quality culture and regulatory excellence strategy. He noted that successfully completing an unannounced GMP inspection without observations strengthens customer confidence in the company’s ability to meet strict international pharmaceutical manufacturing requirements across all operational regions.
As global pharmaceutical supply chains continue to expand across Asia, regulatory inspections conducted by agencies such as the NMPA are becoming increasingly important indicators of manufacturing reliability and compliance performance. Pharmaceutical companies and CDMOs are facing growing pressure to maintain robust quality systems capable of supporting both domestic and international regulatory expectations.
CARBOGEN AMCIS continues to position itself as a leading pharmaceutical outsourcing partner offering integrated drug development, scale-up, and API manufacturing services for pharmaceutical and biopharmaceutical companies worldwide. The company believes the successful Shanghai inspection further strengthens its reputation as a trusted partner capable of delivering compliant, high-quality pharmaceutical manufacturing solutions in highly regulated global markets.
Source: CARBOGEN AMCIS press release
