Strategies Used by U.S. Biotechnology Companies to Attain FDA Quality Compliance

Up to 70% of U.S. businesses in the biotech industry received Food and Drug Administration (FDA) noncompliance citations in 2015. The effective implementation of quality management strategies may lead to improved quality compliance. The purpose of this qualitative multiple case study was to explore the strategies that quality compliance managers in biotech companies use to integrate and apply FDA product quality compliance requirements into their products’ quality compliance metrics. Deming’s strategic models for developing and implementing quality provided the conceptual framework for the study. The study participants consisted of five biotech quality compliance managers in the West region of the United States who had successfully implemented strategies to integrate and apply FDA product quality compliance requirements into their quality compliance metrics. Data were collected from semistructured interviews and public documents. Data were analyzed according to Yin’s 5-step process of compiling, disassembling, interpreting, and making conclusions. Three themes emerged from the data analysis: product quality outcomes, policies and procedures, and collaborative partnerships. A key recommendation includes compliance managers identifying collaborative quality compliance opportunities within and outside their organizations. The implications for positive social changes include the availability of needed drugs for society. Growth in the biotech industry may improve the overall health and living conditions of the public