Speaker
Description
In the pharmaceutical industry, managing non-conformities is not only a regulatory requirement, but also essential for maintaining product quality and patient safety. As processes become more complex, there is a growing need to move from simple deviation tracking to a more structured and data-driven approach. Statistical tools play an important role in this transition by enabling better understanding of process behavior and early identification of potential risks.
At Alkaloid AD Skopje, statistical analysis is integrated into the quality management system as part of routine deviation management. The objective is not only to document deviations, but to analyze them systematically over time in order to detect recurring patterns and identify areas for improvement.
One of the main approaches is the use of trend and control charts. These tools help visualize the frequency and distribution of non-conformities and allow teams to distinguish between normal variability and signals that may indicate underlying issues. Deviations are categorized and grouped based on type, process stage, or potential cause. Correlation analysis is also used to explore possible relationships between process parameters and deviations, such as the impact of environmental conditions or raw material variability.
Experience at Alkaloid demonstrates that applying statistical tools for trend analysis helps identify meaningful patterns, minimizes repeated deviations, and contributes to continuous improvement aligned with GMP and ICH expectations.