Market Complaint Handling procedures are considered as a mandatory Good Manufacturing Practices. Typically, the Market complaints are related to defective or ineffective medicines. Immediate attention must be paid to these complaints with complete evaluation and action to prevent a recurrence.
Pharmaceutical and Biotech companies must establish stringent adherence to the requirements outlined in current Good Manufacturing Practices (cGMP) keeping in mind the processes and control which govern product manufacturing in the pharmaceutical and drug Industry.
With respect to US FDA Section 820.3 (b) of Quality system regulation define, Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.
Sarjen’s QEdge EQMS offers an effective market complaint process to respond quickly to the issues raised internally or externally. Systematic evaluation and root cause analyses will help to prevent recurring of complaints. It identifies the actions (CAPA) to correct the problem and verify the effectiveness of this action.
Not just product related complaints – packaging or quality or others but, also pharmacologic complaints also can be successfully handled in the comprehensiveness of Sarjen’s QEdge EQMS Market Complaint.