FDA’s Center for Drug Evaluation and Research (CDER) is finding that its new “team-based integrated quality assessment” model makes the review process more efficient and effective, and the model is winning the praise of team members involved.
The team approach involves multiple experts simultaneously focusing on their particular areas of expertise across the drug substance and product spectrum of CMC review disciplines, including chemistry, manufacturing process, inspection, microbiology, and biopharmaceutics. In the past, a single reviewer had primary responsibility for the CMC review process as a whole – consulting with other center and field experts generally on an ad hoc basis.
The team-based review approach is one of several significant initiatives CDER has been implementing in conjunction with the formation of its Office of Pharmaceutical Quality (OPQ) to make its regulatory process more effective in assessing product and process quality assurance and in fostering the advancement of a continuous improvement-oriented quality culture.
Along with team-based review and the formation of OPQ, the initiatives encompass: ● risk-based CMC review targeting ● an auditable CDER quality management system ● center-field program alignment ● a pharmaceutical quality IT platform ● mutual inspection alliance with the EU ● enhanced surveillance and quality metrics, and ● a risk-based inspection model.
The quality regulatory initiatives have been taking more concrete shape over the past few months, and CDER Director Janet Woodcock and other senior management have been shedding light on their significance and further implementation plans at recent public meetings, including those FDA has co-sponsored with PDA, the Product Quality Research Institute (PQRI), and the Generic Pharmaceutical Association (GPhA) [See IPQ October 26, 2014 companion story].