Complaint management is a procedure that affects every company, but in the pharmaceutical field, it can also have consequences on the patient’s health. Let’s see how to handle it.

Dr. Eleonora Corbetta spoke about it at the AFI webinar “Pharmacovigilance and quality session”.

The coming of the complaint is a matter that, due to its potential impact on patient safety, must be managed and analyzed following targeted processes, useful for resolving the dispute.

Dr. Eleonora Corbetta, Qualified Person and Quality Assurance manager for the penicillin and sterile lines of ACS Dobfar, shared with the participants in the AFI webinar “Pharmacovigilance and quality session” what is her experience in handling complaints in her own business reality.

Receipt of the complaint and identification of the type

The complaint usually arrives via email by filling in a form by the customer from which it is possible to understand the type of complaint. In the reality of ACS Dobfar, which produces sterile products, in particular injectable antibiotics, these can concern: positive sterility, foreign material, out-of-specification chemical analyses, out-of-specification microbiological analyzes and non-compliance packaging.

For any pharmaceutical company, in any case, knowing the type of non-compliance found by the customer is essential to make a first hypothetical estimate of the misunderstanding that occurred and it is also essential to ask the customer as many details as possible to better address the internal analysis. For example, in the case of an out-of-specification situation, the customer must provide the tests performed by him.

Identification of the origin of the complaint

It is therefore important to know the origin of the complaint, which may be due to:

  • problem on Advance Samples
  • problem during the stability stations
  • problem after filling / packaging the batch not yet released on the market
  • problem on the batch released both by ACS and by the customer and already placed on the market

Identification of the classification of the complaint

The type and origin are essential to determine the classification of the complaint. This must take place immediately after the receipt of the complaint by the customer in order to determine the most important aspect, that is the impact on the SISPQ (Safety Identity Strength Purity and Quality of the product). The complaint has three classifications based on its severity in relation to the potential harm to the patient:

  • critical complaint: the complaint has a very high priority as it has an impact on the customer (for example it has already been placed on the market). In this case, complaint handling times must be very fast. ACS Dobfar internally established a maximum limit of 7 days for the investigation.
  • major complaint: the complaint has a high priority as it has a potential impact on the patient (for example, it has not yet been placed on the market or has already been placed on the market, but has not yet reached the patient). ACS Dobfar internally established a maximum limit of 14 days for the investigation.
  • minor complaint: if the complaint does not have an impact on the SISPQ, it will have a low priority. ACS Dobfar has internally established a maximum limit of 30 days for the investigation of the complaint.

Internal analysis

Upon receipt of the complaint, the QA will carry out an initial risk analysis and immediately afterward a more in-depth investigation is carried out in a meeting with the departments concerned and with the Qualified Person, responsible for placing the lot on the market and therefore, also of his future life.
The following phases will take place during the meeting:

  • Confirmation and reassessment of the seriousness of the complaint and its classification: the complaint will be assessed in an interdisciplinary manner and may be downgraded if further useful information is received by re-evaluating, or if during the time elapsed between receipt of this and the in-depth assessment meeting to decline this claim.
  • planning of activities for investigation: once the complaint has been classified, the activities necessary for its investigation will be planned. These will obviously adapt according to the type, so for example in the case of a complaint about a foreign body, it will be necessary to conduct the investigation also at the laboratory level to verify the nature of this particle. It would be a good idea – suggests the doctor – to have the specific spectra of all the materials present in the company in their laboratory libraries, in order to reduce time and resources to find the corresponding material.
    Once the material has been identified, it will be possible to plan the activities that always include the control of the batch record and the analytical sheet of the batch involved and the training of operators who have developed over the production and analysis of batches.
    It may also be necessary to perform analytical tests again in order to verify the compliance of the product with the specifications and to confirm or not the data found by the customer.
  • planning and verification of stocks in the warehouse and possible segregation: activity necessary to check if the entire quantity of the batch has been sold. If so, it will be necessary to investigate who the buyers were, in order to be able to notify all interested parties of the ongoing investigation; in the negative, the segregation of stocks will proceed.


At this point the most important part is identifying and analyzing the root cause. To do this you can use the various tools offered by the guidelines, such as the “5 why”, rather than the Ishikawa diagram. A fundamental thing, also for inspection purposes, is to never underestimate any probable root cause: if the problem is recurring (easily highlighted by the KPIs) you cannot always limit the attribution of the issue to the usual cause, but, every time it is necessary to analyze every probability and possibly, if any evidence collected allows it to be discarded, report the reasons why it was excluded, otherwise keep it and evaluate it together with the others. For each of these it is necessary to analyze your own Quality System in order to determine whether it allows you to totally eliminate it or not. In the event that the probable root cause is eliminated from the Quality System, but the investigation reveals that there are failures in our system, it will be necessary to fill these failures by identifying the CAPAs.
CAPAs can emerge both due to failures and probable root causes. As well as the complaint, these will be managed with a data integrity system in compliance with CFR 21 part 11, which allows us to track both the complaint, the CAPAs, and any deviations related to it.
At this point you can proceed by determining whether the complaint is justified or not justified.

Once the complaint investigation/management process has been completed, It is possible to analyse the trend on a quarterly and annual basis both with QA and with upper management and QP.