In the highly regulated pharmaceutical industry, every process, however controlled it may be, is subject to deviations, occurrences or unusual production situations that can impact product quality. These deviations pose a serious threat to the efficacy, safety and quality of drugs and should be addressed as nonconformities.

In this article, we will discuss the importance of managing nonconformities and the necessary steps to carry out an effective assessment, as well as how to scale up the resulting actions using the CAPA system.

The importance of managing non-conformities

The pharmaceutical industry is subject to strict regulations from the main sector supervisory bodies. According to pharmaceutical quality standards, any nonconformity that may directly or indirectly affect the quality or effectiveness of a drug, putting the consumer’s safety at risk, must be investigated.

This also includes patient complaints and returns, which are equally important in the quality assurance process.

Inclusion in the Pharmaceutical Quality System (PQS)

A good nonconformity management plan should be part of the Pharmaceutical Quality System (PQS). This plan aims to address nonconformities appropriately, taking into account the associated risks.

Each process and product should be evaluated individually and collectively, involving all participants in the system, and managed by the team responsible for quality in the pharmaceutical company.

Steps for assessing non-conformities:

Below are the essential steps to carry out an effective assessment of nonconformities in the pharmaceutical industry:

  1. Identification and registration: the first step is to identify and record the nonconformity. This can be done using incident reports, customer complaints or other relevant means. It is important to document all relevant information such as the nature of the nonconformity, date, location, people involved and any other pertinent details.
  2. Root cause analysis: once you have registered the nonconformity, it is crucial to carry out a detailed analysis to identify the root cause of the problem. This involves investigating all possible sources or factors that could have contributed to the occurrence of the nonconformity.The use of tools like the Ishikawa Diagram (fishbone diagram) can help in this process, facilitating the visualization and identification of the main elements involved.
  3. Risk assessment: after identifying the root cause, it is important to assess the risks associated with the nonconformity. This will help determine the severity of the impacts on drug quality, efficacy and safety. Risk classification is key to prioritizing corrective and preventive actions, ensuring that resources are allocated efficiently.Check out: 7 methods and tools for risk identification
  4. Corrective and preventive actions (CAPA): based on the risk analysis, immediate corrective actions should be implemented to solve the problem and prevent its recurrence. In addition, preventive measures should be implemented to mitigate future deviations. It is essential to monitor the effectiveness of these actions and make any necessary improvements.
  5. Documentation and monitoring: All steps taken during the assessment of nonconformities should be properly documented. This includes records of investigations and corrective and preventive actions implemented, as well as periodic evaluations of their effectiveness. Ongoing monitoring is essential to ensure compliance and promote continuous process improvement.
In the nonconformity management process, it is important to mention another essential methodology for a robust Pharmaceutical Quality System (PQS): the Corrective Actions and Preventive Actions (CAPA) System.
This system is closely related to Nonconformity Reports (NCRs) according to the need and criticality of identified deviations.

Understanding the CAPA System

The CAPA System determines corrective and preventive actions after analysis of the root cause of a nonconformity. These actions are intended to correct the identified problem and mitigate the occurrence of similar deviations in the future. To achieve this, it is necessary to develop an action plan, obtain the approval of the parties involved, execute it, and monitor it until its completion.

The CAPA system plays a crucial role in the continuous improvement of pharmaceutical industry processes. By implementing corrective actions, it is possible to correct identified problems, eliminating their root causes and restoring compliance with quality and safety standards. Similarly, preventive actions are implemented to prevent deviations from occurring again in the future.

The implementation of the CAPA system requires rigorous monitoring by the Quality team. It is essential to ensure that all stages of the action plan are properly executed and that the results are monitored regularly. This ensures that corrective and preventive actions are effective and preventing the recurrence of nonconformities.


By combining nonconformity management with the CAPA System, the pharmaceutical industry strengthens its Pharmaceutical Quality System (PQS). These systems work together to identify, analyze and correct deviations, as well as implement preventive measures to ensure compliance with standards and drug safety.

The implementation of a well-structured action plan is expected to continuously improve processes, mitigate deviations and ensure the quality and safety of drugs. Proper documentation of the steps is also essential, as it serves as a reference for future analysis and as evidence of commitment to continuous improvement.

In this highly regulated environment, the adoption of a robust Pharmaceutical Quality System, in conjunction with effective CAPA and nonconformity management systems, is essential to ensure patient confidence and compliance with regulatory requirements.

Check out the e-book “Nonconformities and CAPAs: Concepts, tools and practices for the pharmaceutical industry” that we prepared to explain how to put this into practice. You’ll also learn how SoftExpert can automate these processes to make it easier to manage NCRs and CAPAs and help you comply with pharmaceutical regulations.

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Ana Paula Anton


Ana Paula Anton

Ana Paula Anton is a Product and Market Analyst at SoftExpert. She has a degree in Chemical Engineering and a post-graduate diploma in Production Engineering. She has experience in the areas of Processes and Pharmaceutical Quality Systems, in addition to expertise in Good Manufacturing Practices, Risk Management, Audits, Process Validation and Qualification, Cause Analysis, CAPA, FMEA and Validation of Computerized Systems.

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