Navigating The Validation Process For Drug Substances

The process-validation approach for drug substances at AMRI surpasses traditional validation approaches due to its effective method of allocating resources to deliver process understanding from early development through commercialization.

AMRI maps development milestones and associated activities related to validation into three categories: Synthesis Freeze, Process Freeze, and Detailed Process Freeze. This framework closely aligns with the U.S. Food and Drug Administration’s guidance in optimizing development activities and serves as a tool for our clients in clearly understanding the validation process and navigating through the entire development continuum. Each compound will be different and one should use this plan as a guidance tool. The plan for any given molecule can vary depending on it’s synthetic complexity, speed of development and how much risk one is willing to accept.