ABSTRACT
The risk-based life cycle management (RBLCM) process is a risk-based evaluation of pharmaceutical drugs, medical products (MP), devices, and therapeutic products that ensures adherence to product and regulatory requirements. The process assesses current manufacturing, design, and documentation. In addition, product and process performance data is collected to determine if the current design, manufacturing processes, and risk controls continuously mitigate failure modes that could lead to unacceptable harm to a patient/user or could impact a therapy.
