Drug development programs are no exception to the rising importance of quality for pharmacos. Increasing demands by regulators and business partners have made it imperative for quality functions to have scientifically sound processes for review and assurance, rather than solely fulfilling the requirements set out in regulatory guidelines. Regulators have increased enforcement of compliance, especially for vendors and other third parties and for trials conducted outside the European Union and U.S. used for EMA or FDA registration. Indeed, the number of warning letters relating to GCP and GLP has more than doubled in the past five years. At the same time demand is increasing for an evidence-based approach to development activities. This means pharmacos must focus on establishing and verifying a clear, measureable, and objective quality standard and account for the risk-benefit tradeoffs of a particular product or treatment.
Moreover, as margin pressure forces pharmacos to demand greater effectiveness and efficiency (such as by outsourcing clinical trials), there is a greater need for stronger quality oversight. The complexity increases given the ample spectrum of regulations that Quality organizations have to oversee during the drug development process. These regulations range from GLP of some discovery areas and pre-clinical trials to the GCP, GMP, GVP and GDP of the clinical and post-clinical phases. As the FDA has stated, “improving the science of drug development is challenging and requires collaboration”
from each of the diverse stakeholders involved.
A robust approach to quality in development programs is also required to proactively address and minimize vulnerabilities (such as those relating to clinical sites’ compliance and protocol integrity) that could lead to unexpected delays or regulatory interventions.