Quality management department consisting of QC and QA is an effective system for managing quality under the authorization of General Manager. All parts of quality management department are adequately resourced with competent personnel who could fulfill both quality assurance and quality control responsibilities.

We have established an effective quality managing system, covering the whole process from the coming of raw materials and the releasing of final products.

Our laboratory is equipped with advanced testing instruments and all the production related raw materials, packing materials, intermediates could not be released until approved by QA.

The 960 SOPs, records, management documents we have established could cover the whole process of production to minimize the happening of mistakes and cross contamination.

In 2004, we obtained GMP certificate from China Food and Drug Administration and we applied Q7A GMP of ICH to the quality management to meet the demand of internationalization. In May 2005, we obtained DMF (RN: 20050831-1-C-5-03) in South Korea for the key product gliclaizde. At present,  the US DMF application dossiers for 5-ISMN and Isoflurane will be completed soon. In the earlier of Oct. 2007, we received the EDQM COS for Gliclazide.

We stress the auditing for raw material suppliers and the purchasing, use and distribution of all materials are under the control of QA. All the production activities are organized according to pre-approved instructions.

We constantly improve the quality management system and in order to verify compliance with the principle of GMP for APIs, regular internal audits are performed. Audit findings and corrective actions are completed in a timely and effective manner.