Product complaint handling procedure formalised
Ergopharm has formalised its complaint handling procedure, requiring that every complaint be logged, investigated against the retained batch record and assessed for whether a field action is warranted.
A complaint is a signal from outside the quality system, and it is the only one that reports how the product behaved after it left. Handling it as a customer-service matter loses that signal; handling it as a quality record preserves it.
“A complaint is the only report you get on how the product behaved after it left you.”
Each complaint is classified — quality defect, suspected falsification, suspected adverse reaction, or distribution damage — and routed accordingly, with adverse reactions transferred to pharmacovigilance under the applicable safety data exchange arrangements. The investigation examines the retained sample, the batch record and any other complaints from the same batch, and reaches a conclusion on whether other batches or markets could be affected.
Complaint numbers and categories are trended into the periodic product quality review, so that a slow rise in a minor category is visible before it becomes a serious one.
Key facts
- Classified as
- Quality defect, suspected falsification, adverse reaction, damage
- Investigated against
- Retained sample and batch record
- Assessed for
- Whether other batches or markets are affected
- Trended into
- Periodic product quality review
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.