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

Product quality and safety are among the most critical aspects of the pharmaceutical industry. Therefore, 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 in the pharmaceutical industry involve? Check out the most important information.

What Exactly is CAPA in Pharmacy?

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

Identification of Non-conformances

The first step in the CAPA process is to identify actual or potential non-conformances that may 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 continuously monitor every stage of production to detect any deviations from established norms and standards.

Root Cause Analysis

After identifying non-conformances, an in-depth analysis is conducted 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 retraining 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 continued effectiveness.

CAPA Implementation: Pharmacy. 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 Problem 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 address regular audits and training for personnel responsible for cleanliness operations.

Introduction of New Technology

When introducing a new packaging technology that caused unexpected problems with package sealing, corrective actions may include calibrating 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 significantly impact the success of any pharmaceutical company. It is worth noting that CAPA implementation in pharmacy involves various challenges, such as employee resistance to change, cost requirements, and the need for continuous personnel 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.