A systematic approach to classify and reduce recurrent deviations in the pharmaceutical industry: A detailed case study

In the pharmaceutical industry, noncompliance with any good manufacturing practice (GMP) leads to deviation, resulting in potential retention of finished product batches, reprocessing, or rejection—consequently increasing lead time and cost. This study aimed to outline a strategy to define, classify, and mitigate recurrent deviations occurring more than once within 12 months. This research followed an action research methodology, carried out within a Portuguese pharmaceutical company. A transversal analysis of the deviation management process was conducted across three phases: recording, investigation, and conclusion. The intervention included defining objective recurrence criteria, developing investigation models based on structured problem-solving, and redesigning the deviation management information system. The implementation decreased recurrent deviations by 78 percent, and a new process was established, facilitated by the participation and involvement of everyone in the organization. This article introduces pioneering contributions to the pharmaceutical industry by presenting novel criteria for assigning recurrence to recorded deviations and integrating Good Manufacturing Practices (GMP) with big data and analytics. Our approach enhances decision-making and manufacturing processes by structurally incorporating all types of causes beyond the human factor, emphasizing recurring deviations over extended periods. It defines conditions for correct deviation classification and constructs a decision matrix for investigation models. Additionally, it presents workshop management, providing analysis templates and a prototype information system, and outlines key steps to mitigate deviations, highlighting research limitations and future directions.