Summary

The FDA’s updated Concept of Operations (ConOps 2.0) describes how the Center for Drug Evaluation and Research (CDER) and the Office of Inspections and Investigations (OII) coordinate the evaluation and inspection of human drug manufacturing facilities.

The document covers four types of inspection activities: Preapproval Inspections (PAIs), Postapproval Inspections (PoAIs), Surveillance Inspections and For-Cause Inspections. It also incorporates Remote Regulatory Assessments (RRAs) and inspection information obtained through Mutual Recognition Agreements (MRAs) into the agency’s facility evaluation processes. RRAs provide an additional means of assessing establishments remotely but do not, in themselves, satisfy statutory inspection requirements under section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act. By contrast, qualifying inspection reports from MRA partners can fulfil certain FDA inspection requirements under section 510(h) of the Act.

The framework defines the responsibilities of FDA offices at different stages of inspection planning, the assessment of findings, preparation of Establishment Inspection Reports (EIRs), inspection classification and follow-up activities. It also describes the integration of facility evaluation into marketing application reviews, including the role of the Integrated Quality Assessment Team and the assessment of manufacturing establishments before product approval.

The document includes process flow diagrams, an overview of the Integrated Quality Assessment Team and RACI charts defining responsibilities across the relevant FDA offices.

ConOps 2.0 is an internal operating framework for FDA coordination and decision-making. It does not establish new technical CGMP requirements for manufacturers.

Intended audience: Regulatory affairs and quality professionals, pharmaceutical manufacturers supplying the US market, and other stakeholders involved in GMP compliance, manufacturing facility evaluation and regulatory inspections.