China GMP Support: Our Successful Case Study

Here is our summary of our successful study with China GMP’s support.

Guide a US manufacturer with 5 global sites to comply with China GMP

Objectives​

• Determine and identify areas of deviations for its 20+ class III products. ​
• Provide project management and training for different sites to integrate China GMP requirements in its global QMS. ​

Key Activities​

• Reviewed and assessed 20+ class III products China NMPA technical files and IFUs and their associated DHFs. Provided summary of deviation findings for each product. ​
• Reviewed key GMP processes in 5 global manufacturing sites​.

Recommended Areas of Improvement ​

• Recommended implementation areas to be compliant with China GMP in areas such as people/resources, documentation, inspections, storage of materials, cleanroom level, supplier audit requirements, etc. ​
• Developed easy to follow priority and detail tracker matrix for the 20+ products

This case study exemplifies our commitment to helping clients navigate complex regulatory environments and achieve tangible success. At China Med Device, LLC, we take pride in being your trusted partner on the journey to successful market access in China. Read more information regarding the Made-in-China policy.

Guangdong is a leading province to encourage imported devices to localize there with a simplified registration process. View for more information.

View our recorded webinar on NMPA Key Updates on GMP/QMS.

Original Post: https://chinameddevice.com/china-gmp/