Damage Control: Complaints and Recalls

Excerpt from the GMP Compliance Adviser, Chapter 1.G, Complaints and Product Recalls

5 min. reading time | by Heike Meichsner and Susanne Schweizer
Published in LOGFILE 12/2026 

Complaint handling and product recalls are important components of the Pharmaceutical Quality System (PQS). They serve to identify defective medicinal products and ensure that appropriate measures are taken to protect patient safety, as required by law and the competent supervisory authority.

Top Priority: Drug Quality and Patient Safety

Despite the utmost care taken during manufacture, testing, storage and transport, along with a comprehensive quality management system, it is possible that a medicinal product may have a quality defect. 

Complaints of any kind must be registered and investigated to determine whether they could be due to a quality defect or whether drug safety could be compromised. The former is handled as part of the product complaint process, while all aspects of drug safety fall within the scope of the pharmacovigilance system.

If an investigation into a complaint confirms a serious quality defect affecting not just individual packs but the entire batch, it may be necessary to recall the batch from the market promptly so as not to jeopardise patient safety. This is referred to as a product recall, which may be initiated by the manufacturer or the regulatory authority. 

Complaint handling and product recalls are important components of the Pharmaceutical Quality System (PQS). Their purpose is to identify defective medicinal products and take appropriate measures, as the law and the competent supervisory authority requires from the medicinal product manufacturer.

The management of complaints and recalls is closely linked to other elements of the PQS. These include deviations, CAPA and risk management, but also product quality review and quality KPIs.

Who is responsible for Complaint and Recall Management? 

Requirements for handling complaints and recalls can be found in national legislation (for Germany: AMG and AMWHV) and in the EU GMP Guide. In addition, there are requirements from the FDA, ANVISA, WHO, and others, which must also be taken into account depending on the scope of application.

At the country level, those responsible for market interventions bear the main responsibility for complaints and recalls. However, the Qualified Person and the pharmaceutical entrepreneur also have certain obligations to fulfil. 

What is important when handling complaints?

If a defective drug is suspected, a full investigation must be initiated. The investigation should provide information on whether the complaint is justified, whether there is a quality defect, or whether the drug may be counterfeit. To this end, it is important to understand where in the manufacturing, storage, and supply chain such a defect could have originated.

The role of the complaints manager is of central importance in this regard, as they are responsible for involving the right departments in the investigation. They must quickly identify potentially serious defects and notify all relevant persons.

The process flows must be precisely documented in SOPs specific to the company. Once the investigation is complete, the results must be compiled, well documented, and evaluated.

All measures taken must be clearly defined.

Keep calm: What to do in the event of a recall

In the event of a serious defect or confirmed counterfeit drug, the authorities must generally be notified. If there is a potential risk to patients, a product recall from the market must be considered, which must be carried out in close consultation with the relevant authorities.

Such a recall must also be carried out according to clearly defined procedures, which are described in an SOP. 

Regular training of the process is essential to ensure that a recall is carried out smoothly and comprehensively. The law therefore not only stipulates that a product recall must be regulated but also requires it to be carried out regularly. The process is therefore reviewed annually either through a real recall or through a simulated or mock-recall. 

Learning from mistakes

Complaints and recalls must be considered holistically, beyond the investigation of individual cases. Reporting and defining actions, which are ultimately reviewed for effectiveness, ensure that a pharmaceutical company can act safely and quickly in the event of a potential risk to patients. Due to its importance for drug quality and patient safety, complaint and recall management is a key issue in regulatory inspections. 

Well-structured and comprehensive complaint and recall management also serves the goal of continuous improvement, as it allows allegedly individual drug defects to be viewed in the overall context of the product performance and their causes to be successfully eliminated. PQRs, trending, and quality indicators are helpful tools for reviewing the effectiveness of measures.

Looking at the two processes as a whole, it becomes clear how important they are for managing the quality of medicinal products and verifying their safety throughout the medicinal product batch’s entire lifecycle, even after it has been placed on the market and delivered to patients.

Do you have any questions or suggestions? Please contact us at: redaktion@gmp-verlag.de