System to ensure appropriate environmental conditions during transport.
Arrangements for product distribution and methods by which product traceability is maintained.
Complaints, product defects and recalls.
The quality management dept. is responsible for handling with the complaints and ADRs (Adverse Drug Reactions)according to the Standard Management Procedure of Complaints and Recalls.
The drug would be determined to be recalled through the procedures of investigation, analysis and evaluation when potential hazard is found which means the drug may endanger the health and life safety.