The State of Pharmaceutical Regulatory Compliance: Global Changes and Challenges in Large Trading Regions

Manufacturing has been paid dividends for many years through the use of quality tools such as statistical process control, quality function deployment, vendor audit management, hazard analysis critical control points (HACCP), value stream analysis, and other valuation methods. In the highly regulated industries that manufacture pharmaceuticals, foods, and cosmetics, the quality control ‘scientists’ have been typically known to perform sampling and testing for determining the acceptability of finished products. During the past decade, the pharmaceutical industry has seen a significant regulator-industry aligned paradigm change and an important leap into the formality of quality improvement using quality tools. The paradigm of final product testing (and the myth of ‘testing quality into products’) has been challenged by both the industry and regulators. Recent industry and regulatory support of ‘risk-based’ concepts and principles are intended to produce a ‘desired state’ of industry development and production of pharmaceuticals that have a higher level of consistency in meeting purity, safety, and efficacy than in prior history.

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Pharmacy needs to build sustained data and analytics capabilities that support evidence-based decision making and advocacy interventions that inform policy development.

The science of medicine has allowed us to make incredible advances in diagnosing and treating diseases. But the complexity of human biology is staggering. Every person is unique and in many ways, so are diseases. Yet the digital revolution in healthcare provides new ways to both collect high-quality data from each patient and connect it to data from large pools of other patients for analysis. This enables us to arrive at a deeper understanding of how to treat an individual. Only then can we see what distinguishes each of us as individuals, and translate that into personalized and thus improved care for every person. Real-world evidence, molecular information generated from next-generation sequencing, data from wearable devices and mobile apps and novel clinical trials are transforming the future of care.