The Baxter Global Product and Distribution Surveillance (GPDS) organization is responsible for capturing, processing, evaluating, and investigating product quality (non-medical) post market product complaints for all BioScience manufactured and/or distributed products globally.
If during the investigation confirmed quality issues are identified, Baxter has systems in place to address these issues. Depending on the nature and severity of the issue, the Exception Report (ER), Biological Product Deviation Report (BPDR), or a Field Corrective Action FCA processes may be enacted to address and communicate the issue.
The GPDS team collaborates closely with the manufacturing facilities in conducting root cause investigations. The following illustration describes the workflow for the complaint investigation process:
