Independent department,Ensure all manufacture of process comply with demand of SOP.
1.Select .evaluation and approval raw material supplier
2.Establish quality policy and quality objectives and review the management procedures related to production quality
3.Clear responsibilities at all levels.
4.Change Control : Established formal change control system, reviewed and approved by the quality unit. All Changing records should be fully documented by the QA department Archive.
5.Establish quality risk management program, For Quality defects and complaints, Deviation , OOS, OOT
6.Handling of Deviation: To grade the deviation, putting on records to QA, deviation investigations, treatment records kept by the QA.
7.Customer complaints and product recalls:Track each batch according to sales records ,Review batch production record, batch inspection record and writing related record.
Quality Control System
Meet the strictest quality and safety requirements in manufacturing process.
1. Responsible for raw material inspection，sampling, Inspection, material release， HVAC ,environmental monitoring and purified water monitoring ;
2. Ensure the method is confirmed and validated;
3. Reviewing laboratory control records;
4. Managing the retention samples and on-going stability monitoring.