Jaap Koster Knowledge BaseQuality System Elements April 20, 2023 The Critical Role of Proper Deviation Management The pharmaceutical industry is one of the most regulated industries globally, given the critical nature of its products and the potential impact on public health.Ensuring the quality, safety, and efficacy of drugs is paramount, and this is achieved by adherence to strict guidelines and regulations set by the European Union Good Manufacturing Practice (EU GMP) and Good Distribution Practice (GDP) guidelines, as well as the United States Food and Drug Administration (U.S. FDA) guidelines. One essential aspect of compliance with these guidelines is the effective management of deviations and Corrective and Preventive Action (CAPA) processes.In this blog post, we will explore the importance of deviation and CAPA management in the pharmaceutical industry, including deviation management, impact assessments, root cause analysis, and human error reduction. What is a Deviation? A deviation is any departure from the approved processes, procedures, or specifications established for the manufacturing, testing, and distribution of pharmaceutical products. Deviations can occur due to various reasons, including equipment failure, human error, and environmental factors. Deviation management is crucial because it helps maintain product quality and ensures that any discrepancies are quickly identified and resolved.Both the EU GMP and the U.S. FDA guidelines emphasize the importance of a robust deviation management system. This system should include the reporting, evaluation, and investigation of deviations to determine their impact on the quality, safety, and efficacy of the product. A well-structured deviation management system can help companies identify trends and potential areas of risk, thereby enabling proactive measures to prevent future deviations. History of deviations The history of deviations can be traced back to the early days of the manufacturing industry during the Industrial Revolution, which began in the late 18th century. However, it wasn’t until the 20th century that the importance of recording deviations became a standard practice across various industries. Let’s take a deeper look into the origins and evolution of deviations, and why recording them has become so crucial.During the Industrial Revolution, as factories began to produce goods at an unprecedented scale, they quickly realized the importance of maintaining consistency in their production processes. It was crucial to adhere to specific standards and procedures to ensure that products met quality requirements and were fit for consumption. Initially, deviations were informally dealt with, with supervisors and workers making adjustments on the fly to keep production running smoothly. Adoption of deviation methods by pharma As production techniques grew more sophisticated and complex, the need for a more structured approach to managing deviations became apparent. The aviation and automotive industries, with their intricate and safety-critical manufacturing processes, were among the first to adopt formal deviation tracking systems. This was largely due to the potential catastrophic consequences of any discrepancies or defects in their products.The pharmaceutical industry soon followed suit, recognizing the importance of tracking and documenting deviations to ensure product safety and efficacy. The early 20th century saw the emergence of Good Manufacturing Practices (GMP), which laid the groundwork for managing deviations in pharmaceutical production. GMP guidelines emphasized the importance of recording, investigating, and addressing deviations to maintain the integrity of products and protect public health.In the latter half of the 20th century, the concept of deviations expanded to include not only manufacturing processes but also management systems and organizational behavior. The International Organization for Standardization (ISO) developed the ISO 9000 series of standards, which introduced the concept of a Quality Management System (QMS). A QMS provided a framework for identifying, recording, and managing deviations within an organization, ensuring that processes were continuously improved and customer requirements were met. Learn more about the origins of robust pharmaceutical qualityRead our articles on the GMP's origins Read articles Why proper deviation management is critical To illustrate the importance of proper deviation management we will use the case of XYZ pharmaceuticals (fictional name). XYZ had been in business for many years and was known for producing high-quality, safe medications. However, as the company expanded and the management team changed, the focus on quality and compliance began to wane. In an attempt to cut costs and increase profits, XYZ started to ignore proper deviation management practices.One day, a deviation occurred in one of XYZ’s manufacturing lines. The line supervisor, Sarah, discovered that the raw material used in the production of a blood pressure medication was not up to the required specifications. Concerned about the potential impact on product quality, Sarah reported the deviation to her manager, Tom. Tom, under pressure to meet production targets, decided to brush the issue aside and instructed Sarah to continue with the production process.As a result of this decision, the compromised raw material was used in the manufacturing process, and the finished medications were shipped to patients. Within weeks, reports of adverse effects and patient complaints started to pour in. The medications made with the substandard raw material were causing unexpected side effects, and in some cases, even posed a risk to patient safety.Meanwhile, a surprise inspection from the FDA revealed XYZ Pharmaceuticals’ inadequate deviation management practices. The company was found to be non-compliant with industry regulations, such as Good Manufacturing Practices (GMP). Consequently, XYZ Pharmaceuticals faced severe penalties, including fines, product recalls, and damage to their reputation.This real-life example underscores the importance of proper deviation management in maintaining product quality, safety, and regulatory compliance. By ignoring deviations and neglecting to address them appropriately, companies like XYZ Pharmaceuticals can suffer significant consequences that ultimately harm their customers, reputation, and bottom line.You might be wondering; how could proper deviation management have prevented Tom from brushing the deviation aside?Proper deviation management could have prevented Tom from brushing the deviation aside by incorporating the following principles and practices:Culture of quality and accountability: A strong organizational culture that emphasizes the importance of quality and safety would help ensure that deviations are taken seriously. This would involve training and empowering employees at all levels to prioritize quality and compliance, including understanding the potential consequences of ignoring deviations.Clear reporting procedures: Establishing clear, standardized procedures for reporting deviations would make it difficult for Tom to brush the issue aside. These procedures should outline the roles and responsibilities of each team member and the escalation process in case of unresolved deviations or disagreement on their handling.Risk assessment: Implementing a mandatory risk assessment process for every deviation would require Tom to evaluate the potential impact of the raw material issue on product quality and safety. This would bring the seriousness of the problem to his attention and help him understand the potential consequences of not addressing it. Become a CAPA & Deviation expert PCS has an extensive one-day training course on this topic! Learn how you can increase the quality, effectiveness and implementation of your CAPA's. Participants score this training 8.7 out of 10! Click here to learn more! TRAINING Documentation and tracking: Proper documentation and tracking of deviations would create a paper trail that holds employees accountable for their actions. By ensuring that all deviations are recorded, investigated, and resolved, it would be more difficult for Tom to disregard the issue without facing consequences. Involvement of upper management: In cases where deviations are not addressed promptly or adequately by line managers, escalation procedures should involve upper management. This would provide an additional layer of oversight and accountability, ensuring that serious deviations are not overlooked. Periodic audits and reviews: Regular internal and external audits or reviews can help identify and address gaps in deviation management practices. By consistently monitoring and evaluating the company’s deviation handling, the organization can promote compliance and identify areas for improvement. By implementing proper deviation management practices, XYZ Pharmaceuticals could have ensured that deviations, such as the one discovered by Sarah, were addressed promptly and effectively. This would have prevented Tom from brushing the deviation aside, protecting product quality, patient safety, and the company’s reputation. Deviation examples Deviations in the pharmaceutical industry can occur at any stage of the manufacturing, testing, and distribution process. They can result from equipment malfunctions, human errors, environmental factors, or procedural issues. Here are some examples of deviations in pharma: Topic Example deviation Equipment Failure A malfunction or breakdown of equipment, such as mixers, filters, or filling machines, can lead to deviations in product quality, yield, or purity. Process Deviations Variations in process parameters, such as temperature, pressure, or mixing time, can result in deviations from the established process specifications. Raw Material Issues Use of expired, contaminated, or incorrect raw materials or active pharmaceutical ingredients (APIs) can lead to deviations in product quality or potency. Documentation Errors Inaccurate or incomplete documentation, such as batch records, standard operating procedures (SOPs), or logbooks, can result in deviations and hinder traceability. Product Contamination Contamination of the product, either through cross-contamination from other products or contaminants from equipment, personnel, or the environment, can result in deviations in product purity or safety. Deviation reporting best practices Every pharmaceutical company has it’s own standards and best practices for reporting deviations. Your company’s standards should always be adhered to, however, we can distill a number of best practices in reporting deviations in GMP and GDP environments. Timely reportingPromptly report deviations upon discovery. Quick identification and reporting allow for faster corrective actions and minimize potential risks to product quality or patient safety. DocumentationDocument the deviation in detail, including the date, time, location, personnel involved, and a clear description of the incident. Provide any relevant supporting information, such as batch numbers, equipment logs, or photographs. Risk assessmentPerform a thorough risk assessment to evaluate the potential impact on product quality, safety, or efficacy. Consider both immediate and long-term consequences. CategorizationClassify the deviation based on its severity and impact on product quality, safety, or efficacy. Categories may include minor, major, or critical deviations. InvestigationConduct a thorough investigation to determine the root cause of the deviation. This may involve interviews with personnel, review of relevant documents, and examination of equipment or processes. Use a structured approach, such as the fishbone diagram or 5 Whys, to help identify the root cause. Corrective and Preventive Actions (CAPA)Develop and implement appropriate corrective actions to address the immediate issue and prevent recurrence. Preventive actions may include additional training, process improvements, or equipment modifications. Follow-upMonitor the effectiveness of the implemented CAPA and ensure that the deviation does not recur. Conduct periodic reviews to verify that the actions taken have been successful. CommunicationEnsure clear and transparent communication among all relevant stakeholders, including internal teams, management, and regulatory authorities if required. Keep everyone informed of the progress of investigations, CAPA implementation, and follow-up actions. TrainingUse deviation events as opportunities for learning and improvement. Provide training to relevant personnel to prevent similar deviations in the future. Continuous improvementIntegrate deviation management into your quality management system and use the lessons learned from deviations to drive continuous improvement initiatives. Regularly review and update procedures, guidelines, and training programs to stay current with industry best practices and regulatory requirements. Improve the quality and accuracy of your deviations? PCS provides on-the-job consultancy! Get in touch with us to discuss your needs. quality system Share on Facebook Share on Twitter
Good Manufacturing Practice (GMP)Knowledge BaseQuality OriginsThe origins of robust pharmaceutical quality: Contaminated Infusion Fluids April 24, 2023
Knowledge BaseQuality OriginsOrigins of robust pharmaceutical quality: The Elixir Sulfanilamide disaster April 18, 2023
Good Manufacturing Practice (GMP)Knowledge BaseWhy is Quality so Important in Vaccine Production? February 28, 2023
Good Distribution Practice (GDP)Knowledge BaseLicensing in the European UnionGDP for transportation companies of medicinal products (without storage) September 7, 2022