We must now rethink our design strategies and planning processes before starting studies to find the right fit-for-purpose virtual solutions and push the boundaries on our designs to ensure we are collecting what is truly important for research and our patients.
This article is the second in a series examining strategies that allow quality groups to collaborate with GCP and GMP groups to improve ICH E6(R2) compliance, increase clinical study robustness, and enhance data integrity.
Despite quality audits and third-party oversight, contamination of prescription and over-the-counter (OTC) pharmaceutical products is still prevalent. This is despite the adoption of cGMP practices, SOPs, risk mitigation methods, and metrics such as key performance indicators. We evaluated various emerging practices to overcome contamination issues. Novel batch concentration tests and dedicated capacity utilization have proven to overcome the source of contaminants. For technology adoption in continuous manufacturing, which is unclear in terms of compliance, the FDA Emerging Technology Team could be used for advisory oversight.
Development of a successful and sustainable training program requires appropriate policies for guidance, as well as an infrastructure to ensure proper development, deployment, and administration.