Measuring Pharmaceutical Quality

Pharmaceutical manufacturers are expected to have a continuous improvement program in place to monitor the performance of their operations, detect any underlying issues, and make the necessary corrections. This usually involves the collection of data and statistical analysis of the data.

For years, FDA has been advocating the adoption of modern quality systems and risk management approaches in pharmaceutical manufacturing, noted Prabir Basu, consultant, Mt. Prospect, IL, US, and Professor Thomas Friedli from the Institute of Technology Management, University of St. Gallen, Switzerland in the 2016 CPhI Annual Industry Report. The idea is to establish management controls to support and maintain a company’s cGMP compliance status, as recommended in FDA’s guidance documents.

FDA provides a clear definition of a pharmaceutical quality system (PQS) and how to measure the performance of the PQS while defining quality systems for drugs. According to FDA, “The requirements of good manufacturing practice are underpinned by a central objective: to create a system of programs, policies, processes, and facilities that prevent errors and defects. A PQS is successful when it assures an ongoing state of control. In a healthy PQS, managers establish a vigilant quality culture in which timely action is taken to prevent risks to quality. Lifecycle adaptations are made to address manufacturing weaknesses and continually improve systems. An effective process performance and product quality monitoring program provides early warning of emerging quality issues. Systemic solutions are implemented rather than ineffective shortcuts. A firm will also habitually attend to the seemingly small problems that quality experts remind us later would accumulate into costly, complex problems. An effective PQS will ultimately support stable processes, and predictable quality and supply.”

Managing quality of pharmaceutical operations requires a systems approach, said Basu and Friedli. They stressed that the choice of metrics used to measure the performance of a pharmaceutical operation are crucial. Instead of using lagging indicators that measure the symptoms such as batch failure rate, metrics should be systems oriented.

Given that continuous improvement is the goal, measurements must be linked to processes and reflect process performance. There has to be a feedback loop where an action is attached to the measurement result such that depending on the measurement, some actions are taken to adjust, correct, or improve the processes.

In the 2016 CPhI Annual Industry Report, Basu and Friedli also reviewed a new systems based approach to quality metrics-following the University of St. Gallen receiving a grant from FDA to undertake this project. They recommend a measurement system based on an operational excellence (OPEX) model, developed by the University of St. Gallen.

The important components of a true OPEX program, as noted by Basu and Friedli, are continuous improvement, management commitment, and employee involvement. In principle, there is an excellent match of the key components of OPEX and those of an ideal quality system, they said. According to them, it makes sense to develop and integrate the metrics for OPEX implementation with appropriate metrics for “Quality” for pharmaceutical manufacturing operations.

Source: CPhI Annual Industry Report 2016