During the AFI webinar “Pharmacovigilance and quality” on 27th November, Dr. Donata Saddemi and Dr. Barbara Belloni respectively Pharmacovigilance Manager & Regulatory Associate and QA Manager & Qualified Person of the pharmaceutical company Recipharm Italia, illustrated their complaint management flow.
The reality of Recipharm Italia can be more complicated than other situations as it is a group composed by four production sites, two of which are Marketing Authorisation Holders.
For the complaint management has been developed a flow that meet the two variables: involvement of the company as a production site, therefore in the event that the object of the complaint is the product of a customer, or involvement as MAH.
The flow, developed in synergy by the quality and the pharmacovigilance department, evolves as follows:
- Receipt by the quality department of a complaint about a defect and/or adverse event
- Registration of the complaint by the quality department
- Internal notification to the pharmacovigilance department. If, on the other hand, pharmacovigilance receives the report directly, then it has to report to the quality department, which will register the complaint.
- Execution of the analysis.
The pharmacovigilance department looks for for any safety information. If so, the second variable will be analyzed, that is the ownership of the product. If Recipharm is involved only as a manufacturer, it is necessary to transfer the information to the client company according to agreed times and methods; if the ownership is of Recipharm, then the pharmacovigilance department records the data in the pharmacovigilance database.
The quality department, in parallel, starts the qualitative investigation which includes: document review of everything that may concern the defect; review of historical data to highlight any Trend (analysis both by product and by defect); analysis of counter-samples and claimed samples; root cause analysis.
- After the analysis, we proceed with the determination of whether or not the complaint is confirmed.
In both cases, the investigation is closed and a final report is issued which is sent to the customer. However, if the complaint is confirmed, it is possible to intervene with actions on the batches and, in extreme cases, it may be necessary to recall the batch. All activities are tracked in the quality system. The customer, especially in the case of subcontractors, can comment and possibly addendum to complaints.
In any case, the information passes through the pharmacovigilance, if there is an impact on safety it must integrate the information that emerged through follow up. In the event that the subject of the complaint is a product owned by Recipharm, the pharmacovigilance will update the data in the database, if instead the product is a third-party account, all the information is transferred to the customer’s pharmacovigilance within the agreed timescales.
Beyond the individual complaint submission cases, there are several other activities that the Quality and Pharmacovigilance departments must carry out, including: reviewing and linking complaints and pharmacovigilance procedures, staff training, review of the Quality Agreement, the revision of the SDEA (Safety Data Exchange Agreement), the reconciliation between departments and between customers, and finally the analysis of trends. The latter, to be carried out annually, checks the number of complaints, the number of adverse events, the type of events and root causes. In the event that a trend emerges, it is necessary to proceed with the definition of the additional actions that must be traced in the quality system.
These are all activities necessary to guarantee the safety and efficacy of the products, as well as their quality.
Patient safety is a very complex world – the two doctors conclude – the collaboration and integration of the quality and pharmacovigilance departments is therefore fundamental.