Measures designed to increase efficiency in pharmaceutical quality control

In recent years, the quality control departments of pharmaceutical companies have been placed under considerable and ever-increasing pressure: On the one hand, they are expected by their companies to contribute to overall cost-cutting and to rationalise their analytical processes; and on the other, they are exposed to pressure from customers and regulatory authorities to provide a high and increasing level of quality assurance in all of their analytical procedures. In particular, the proportion of formal but "nonproductive" activities such as qualification, validation and the investigation of out-of-specification analytical results is constantly increasing. The fact that there is no adequate benchmarking system available for quality control work has led to numerous and different proposals being made to solve this particular problem. These range from organisational measures such as the integration of quality control activities into in-process control laboratories to the relocation of entire laboratory units to sophisticated strategies based on automation. The enclosed article attempts to define the capacity factors involved and to show how optimisation can be achieved by allowing quality control departments to work independently, i.e. without recourse to consultants and advisers, thereby increasing their efficiency.