In September 2015, our company was inspected by Germany Authority for the manufacture of Filgrastim, after several months of hard work to complete the CAPA, we finally got GMP certificate in May, 2016.
During the inspection, auditors from Germany inspected our manufacturing facility according to the requirement of EU GMP, they checked quality management system, personal sanitation, materials storage and release, products dispatch and recall, documents system etc. There was no critical point found.
It is a good opportunity for us to develop more overseas markets after this certificate was granted.