Principles for Effective Regulatory Active Pharmaceutical Ingredients Policy

This article develops the premise that there are a few fundamental principles that underlie the effective regulatory active pharmaceutical ingredients (API) policy/practices of individual companies, as well as of the Food and Drug Administration (FDA) itself. These principles become evident when one evaluates, retrospectively, ineffective API policy/ practices and critically examines the basic reason(s) for their ineffectiveness. The principles are: Science-based decisions; APIs are not dosage forms; continuity; and proportionality. In addition to discussing each principle, they are also presented in the context of specific API issues, including process changes, investigational new drug/new drug application (IND/NDA) documentation, current Good Manufacturing Practices (cGMPs) and process validation. Practical recommendations are offered concerning the “how” of applying these principles.