FDA Updates Framework for Coordinating Facility Evaluations and Inspections
FDA has revised its framework for collaboration between the Center for Drug Evaluation and Research (CDER) and the Office of Inspections and Investigations (OII). Version 2.0 of the Concept of Operations (ConOps), effective October 21, 2026, supersedes the original June 2017 version.
The document, “Integration of FDA Facility Evaluation and Inspection Program for Human Drugs,” describes how CDER and OII coordinate facility evaluations supporting marketing application assessments, inspections, and related compliance activities. It covers preapproval, postapproval, surveillance, and for-cause inspection processes.
Key updates include:
- Alignment with FDA’s October 2024 reorganization;
- Incorporation of Remote Regulatory Assessments (RRAs) and inspection reports obtained under Mutual Recognition Agreements (MRAs) as evaluation tools;
- Clarification of roles and responsibilities across all covered inspection types.
The updated framework aims to support risk-based, consistent, and transparent facility evaluations. Closer collaboration and improved access to information are intended to reduce duplication, enhance operational efficiency, and help FDA meet regulatory timelines and user fee commitments.
Source:
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may Also be Interested in the Following Articles
