Quality defects in medicinal products

What is a quality defect in a medicinal product?

A quality defect in a medicinal product is defined as any instance of non-compliance with the specifications set out in the Marketing Authorisation (MA) application, or a deviation from Good Manufacturing Practice (GMP). This defect could impact on the quality, safety and/or efficacy of the product.

Quality defects include:

Contamination by chemical, particulate or microbiological matter;
Quantitative anomalies (e.g. tablet missing in a blister pack);
Qualitative anomalies (e.g. product exhibiting an unusual appearance, smell, colour, transparency);
Packaging anomalies (package leaflet, packaging).

These defects can be detected at several different levels, including:

During analysis carried out as part of quality controls by marketing authorisation holders and/or their representatives;
By wholesalers;
When the product is dispensed by a retail pharmacist or hospital pharmacist;
When the product is used by a patient or healthcare professional;
During analyses carried out as part of market surveillance operations by the DPM or other competent authorities;
When reporting a pharmacovigilance case.

The quality defect may or may not cause harm to the patient and/or the healthcare professional. The quality defect can affect certain items in a batch, an entire batch or several batches.

Quality defects can be broken down into three categories:

Why should quality defects be reported?

A quality defect could adversely affect patients' health or safety.

Whenever a quality defect is reported, the marketing authorisation holder or their authorised representative conducts an in-depth investigation to determine the causes and consequences. Quality defects can result in batches being recalled at national level or even European level (depending on defect), or in changes being made to the safety precautions published by the marketing authorisation holder. Any decision to recall a batch is approved by the DPM.