STATEMENT OF NON-COMPLIANCE WITH GMP - JINAN JINDA PHARMACEUTICAL CHEMI. CO LTD, CHINA

The site was inspected by EDQM in June 2015 and found non-compliant; as a result, the site’s CEP was suspended. Despite the 2015 non-compliance, sales to EU customers continued (list available by EDQM on authorities’ request). The Company has been found to be not GMP compliant; a total of 30 deficiencies were identified in total, two of them classified as critical and eight as major. The CAPA for the previous EDQM inspection (June 2015, CEP suspension) report were found as not having been implemented in a satisfactory way. Critical deficiencies were found on raw data safety, control and OOS review. Moreover, several major deficiencies were found in training, change control, quality assessment, process and cleaning validations.

This inspection was performed in the frame of the Spanish collaboration on EDQM inspection programme.

Source: Eudragmdp