Implementing CAPA in the pharmaceutical industry. What do you need to know?

Product quality and safety are among the most important aspects of the pharmaceutical industry. That’s why CAPA (Corrective and Preventive Action) systems are a fundamental tool for managing appropriate standards at various stages of production. CAPA is a process designed to identify, analyze, and eliminate the root causes of non-conformances and potential non-conformances to prevent their recurrence. What exactly does its implementation involve in the pharmaceutical industry? See the most important information.

What is CAPA in pharmaceuticals in general?

The CAPA system is required by organizations worldwide, including the FDA (U.S. Food and Drug Administration) and the EMA (European Medicines Agency), which emphasizes its universality and importance in the pharmaceutical sector. At each stage of CAPA, specific actions are taken. What are they most often related to?

Identification of non-conformances

The first step in the CAPA process is to recognize actual or potential non-conformances that can occur in any aspect of pharmaceutical production. These non-conformances can be identified through internal audits, customer complaints, control product reviews, or drug stability test results. Specialized quality teams must constantly monitor every stage of production to catch any deviations from established norms and standards.

Root cause analysis

After identifying non-conformances, an in-depth analysis is carried out to determine the root cause of the problem. Techniques such as the “5 Whys” analysis or Failure Modes and Effects Analysis (FMEA) allow teams to get to the root of the problems. The goal is not only to understand what happened, but above all, why the non-conformance occurred.

Corrective and preventive actions

Corrective actions focus on eliminating the identified non-conformance, e.g., by repairing equipment, changing procedures, or training personnel. Preventive actions, on the other hand, aim to reduce the risk of future problems by implementing improvements, which may include technological innovations, changes in process design, or the introduction of new monitoring protocols. It is important that these actions are observed and reviewed to ensure their continuous effectiveness.

CAPA implementation: pharmaceuticals. What does it look like in practice?

How does CAPA implementation proceed in practice? See what solutions can be implemented using the example of two different problems in the pharmaceutical industry.

Cleanliness problems in the production process

If contamination is detected in a batch of medication, the root cause analysis may indicate inadequate cleaning procedures for production equipment. Corrective actions could include reviewing and improving cleaning procedures, while preventive actions should involve regular audits and training for personnel responsible for cleanliness of operations.

Introduction of new technology

When introducing new packaging technology that caused unexpected problems with packaging hermeticity, corrective actions may include calibration of packaging equipment, while preventive actions may focus on early testing of packaging prototypes before full technology implementation.

Summary

The CAPA system requires continuous monitoring and adaptation, but the benefits of its implementation are long-term and have a significant impact on the success of any pharmaceutical company. It is worth noting that CAPA implementation in pharmaceuticals involves various challenges, such as employee resistance to change, cost requirements, and the need for continuous staff training. The advantages of an effectively implemented system are significant and include improved product quality, increased patient safety, and compliance with international regulatory standards.

Also, read our article about what the HACCP system covers.