Towards a New Journey of Internationalization | Shupusida Accepts On-site Inspection by Brazil's Official GMP System Review Team for the First Time


From July 11 to 14, 2023, the registered GMP system review team of Brazil's National Health Supervision Administration visited Schuster for GMP certification, and was warmly received by the host Nanjing Schuster General Manager Tang Xuefeng and other senior officials.

 

Brazil ANVISA represents the highest level of food and drug management in South America, and its strictness is equivalent to that of EDQM of the European Union and FDA of the United States. This inspection is the first time that our company has accepted the on-site inspection of Brazil's official GMP.

 

At the beginning of the meeting, the registered GMP system review team introduced the ANVISA system, organizational structure, and the composition of the inspection team, and reviewed the product range: ventilator, anesthesia system, non-invasive ventilator, oxygen generator, continuous positive airway pressure system.

 

 
During the four-day inspection, the ANVISA inspector conducted a comprehensive, professional and rigorous inspection of the company's R & D center's development and design process, quality management system, material control system, production workshop and warehouse. At the last meeting, the inspector gave full affirmation to the company's overall operation level.

 

The inspection of the GMP system review team has taken the first successful step for our subsequent ANVISA certification. The company will also use this review as an opportunity to continuously improve the quality management level, improve product quality, and increase the international reputation of Shupusida. Enter the Brazilian and South American markets to provide a strong guarantee.