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Quality & EHS

Quality&EHS

Quality Policy


The best product is produced through the best equipment, the best management and the best staff; 

The trust of customer is acquired through the progressive management, the truly working and the highly quality.


The Quality department (QA) reports directly to the general manager and is independent from production department. The QA is involved in all quality-related matters, review and approve all appropriate quality-related documents.


The QA operates in accordance with ICH Q7 and ensures continuing compliance with Chinese, EU and US cGMP rules and regulations. The main responsibilities of QA include but not necessarily be limited to:

 

1.Releasing or rejecting all APIs.  Releasing or rejecting intermediates for use outside the control of the manufacturing company; 

2.Establishing a system to release or reject raw materials, intermediates, packaging and labelling materials; 

3.Reviewing completed batch production and laboratory control records of critical process steps before release of the API for distribution;  

4.Making sure that critical deviations are investigated and resolved; 

5.Approving all specifications and master production instructions; 

6.Approving all procedures impacting the quality of intermediates or APIs; 

7.Making sure that internal audits (self-inspections) are performed; 

8.Approving intermediate and API contract manufacturers;  

9.Approving changes that potentially impact intermediate or API quality; 

10.Reviewing and approving validation protocols and reports;  

11.Making sure that quality related complaints are investigated and resolved; 

12.Making sure that effective systems are used for maintaining and calibrating critical equipment; 

13.Making sure that materials are appropriately tested and the results are reported;  

14.Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates where appropriate; 

15.Performing product quality reviews


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