Facing a complaining customer, or better a patient in our case, is the opportunity for a CDMO to show its know-how and thus to take care of its image. For this, the Client and the CDMO must set up an organization, a partnership to process complaints quickly and efficiently. The goal is to consider its CDMO as a partner and not as an enemy.
It is up to each client to define the best method for organizing the complaints system. Several communication channels (mail, e-mail more often) with its CDMO can be used to:
On CDMO side, people dedicated to complaint registration and processing are part of the Quality Assurance department, and are experts of the product and production processes.
The complaint acknowledgment is the starting point of the quality report lead-time, agreed between the parties.
Initially The CDMO report lead-time will depend on the criticality of the complaint.Anyway the processing time has to be the shortest possible to limit the reminders from the client but as well above all to avoid any risk of problem’s new occurrence.
However it is necessary to give enough time to allow the CDMO to carry out a relevant, situation analysis in order to define the most adapted corrective and preventive actions.
On both sides a rigorous traceability of recorded complaints and corresponding samples must be implemented.
As mentioned above, the CDMO has the process expertise. Sometimes patient complaints could be “exotic”. Let’s look at a case inspired by real facts: “How can you make this foul taste product?” To be internally translated by “is there a taste issue with this batch?”. Always give the doubt benefit to the complainant. The act of complaining is important in the shoes of the person who does it. However without sample not easy to investigate further. Also it quickly becomes necessary to get it so that the CDMO can confirm the defect and its root cause or bring the proof of the opposite.
Traceability of complaints is as well necessary to chase recurrent issues that occur on a product, on a particular production line.
The CDMO must provide a detailed investigation report to the client with proposals for action where appropriate and a commitment on implementation deadlines.
It will also forward the issue of the patient to the corresponding operators (manufacturing, packaging…) in order to keep them aware of the potential market issues.