Change often takes years longer in the pharmaceutical industry than in others. Why can we not challenge that paradigm? The auto industry, for example, successfully forced changes to its supplier base within a couple of years. By benchmarking other industries that have dealt with similar problems,...
Water-borne microorganisms are ubiquitous and varied in their ability to survive and grow under different conditions. Therefore, an out-of-control water system can cause harm to the patient or adulterate pharmaceutical products. Purification of water is...
Understanding the fundamental assumption of independence (and the violation thereof) enables an appropriate response to control chart trend rule violations and challenges us to think differently about special cause variation in control charts.
As part of their quality risk management (QRM) programs, many biopharmaceutical manufacturers have made deliberate efforts to classify systems, equipment, and components by their potential to affect product quality. In assessing these risks, it is...
The Food and Drug Administration (FDA) report “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach”14 was an introduction to quality by design (QbD), the concept that quality should be built into a product. According to the FDA report...
