Carbogen Amcis, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announces the successful completion of its first Brazilian Regulatory Authority Agency (ANVISA) routine inspection of its facility in Shanghai.
Between 6-10th November 2023, a five-day inspection was undertaken, which concluded successfully with no critical and no major observations raised.
A Good Manufacturing Practice (GMP) certificate has been granted to the site by the authority.
Pascal Villemagne, CEO of CARBOGEN AMCIS, said: “I want to congratulate the Shanghai team on their first successful independent regulatory inspection, and for being commended by the inspectors for their transparent and open approach. The GMP certification is a reflection of our high-quality standards and the commitment of our teams at this important site.”
Carbogen Amcis’ Shanghai site employs 140 people and specialises in large-scale manufacturing of raw materials, intermediates and API; manufacturing of highly potent chemicals up to category III, GMP product release and analytical support for development activities.
The ANVISA audit was focused on areas including utilities, maintenance and calibration, production, quality control and assurance.
