The US Food and Drug Administration (FDA) has updated its operating framework for evaluating and inspecting human drug manufacturing facilities. The revised Concept of Operations (ConOps), dated 21 October 2026, formalises the use of remote regulatory assessments and inspection information from international regulatory partners, while clarifying how the agency’s drug review and inspection teams coordinate their work.

FDA’s framework for GMP inspections and facility evaluation

The FDA’s updated document, Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations, describes how the Center for Drug Evaluation and Research (CDER) and the Office of Inspections and Investigations (OII) coordinate facility evaluations, inspections and related compliance activities.

The revised framework replaces the previous version published in 2017 and reflects organisational changes introduced by the FDA, including the transition from the Office of Regulatory Affairs (ORA) to OII in 2024.

The document covers four main types of inspection activity at human drug manufacturing facilities:

• Preapproval Inspections (PAIs)
• Postapproval Inspections (PoAIs)
• Surveillance Inspections
• For-Cause Inspections

It also describes how Remote Regulatory Assessments (RRAs) and information obtained through Mutual Recognition Agreements (MRAs) are incorporated into facility evaluation and regulatory decision-making.

The update is not a new set of GMP requirements for manufacturers. Rather, it defines how FDA offices share information, allocate responsibilities and reach decisions based on inspection findings and other available evidence.

Remote regulatory assessments in FDA facility evaluations

One of the most important elements of the revised ConOps is the formal inclusion of Remote Regulatory Assessments.

Remote regulatory assessments may involve the review of records and other information submitted in response to an FDA request under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act. They make also take the form of remote interactive evaluations such as remote livestreaming of operations, teleconferences and screen sharing.

Under the updated framework, RRAs may support different stages of facility evaluation:

• Preapproval: where a PAI is not considered necessary, CDER may use an RRA to address outstanding concerns identified during the application assessment and continue monitoring the establishment’s CGMP status in relation to the pending application
• Postapproval: remote assessments can help evaluate residual risks identified during the application review and monitor the manufacturing lifecycle
• Surveillance: a quality system assessment through an RRA may be considered for establishments in Travel Warning Areas (Level 3 or higher) or other areas identified by FDA where an inspection required under Section 510(h) cannot feasibly be conducted within the relevant fiscal year
• For-Cause: targeted information requests or broader quality system assessments may be used in response to specific compliance concerns

The FDA nevertheless makes an important legal distinction. An RRA conducted under Section 704(a)(4) does not itself satisfy an inspection requirement under Section 704(a)(1), because it does not involve physical entry into the establishment.

Consequently, an RRA should not be interpreted as an automatic substitute for a legally required on-site inspection. Its findings can, however, influence inspection planning, priorities and subsequent regulatory decisions.

How FDA uses international GMP inspection reports

The revised framework also describes more explicitly how the FDA uses inspection reports obtained through Mutual Recognition Agreements.

The agency has agreements with the European Union, Switzerland and the United Kingdom. These arrangements allow participating regulatory authorities to recognise and use each other’s inspection information and findings under defined conditions.

Under ConOps 2.0, reports from these regulatory partners can contribute to the assessment of a manufacturer’s compliance with US current good manufacturing practice (CGMP) requirements. They can also support recommendations concerning regulatory applications and the evaluation of facilities supplying the US market.

A particularly important distinction concerns the legal status of these reports.

Unlike RRAs conducted under Section 704(a)(4), qualifying inspection reports from MRA partners can fulfil certain inspection requirements under Section 510(h) of the Federal Food, Drug, and Cosmetic Act.

For surveillance inspections, CDER and OII can request, assess and classify relevant MRA inspection reports. The framework also describes how information from MRA partners may be considered in preapproval and for-cause evaluations.

For manufacturers operating across several jurisdictions, this means that inspection outcomes obtained from recognised regulatory partners can have direct relevance to FDA’s assessment of a facility.

Integration of application reviews and preapproval inspections

The revised ConOps places particular emphasis on integrating manufacturing facility evaluation into the review of marketing applications.

For preapproval evaluations, CDER uses an Integrated Quality Assessment Team comprising specialists from different areas of pharmaceutical quality assessment.

The team considers information about the drug, its manufacturing process, the establishments named in the application and the available inspection history. The Office of Pharmaceutical Manufacturing Assessment (OPMA) conducts an initial establishment risk assessment using application information, previous inspection outcomes, including MRA inspection reports where available, and other quality intelligence.

Based on this assessment, CDER determines whether a Preapproval Inspection is necessary or whether a remote regulatory assessment can address outstanding concerns.

When an on-site inspection is required, OII generally leads the inspection, with CDER participation where appropriate. Information identified during the application review is communicated to the inspection team so that relevant concerns can be addressed during the inspection.

The process is intended to ensure that manufacturing capabilities, control strategies and the accuracy of submitted application data are considered together when assessing the quality-related approvability of a marketing application.

FDA inspection responsibilities and reporting timelines

ConOps 2.0 also provides more detailed descriptions of responsibilities across the four inspection types. Its appendices include process flow diagrams, an overview of the Integrated Quality Assessment Team and RACI charts identifying which FDA offices are responsible, accountable, consulted or informed at different stages.

The framework specifies timelines for preparing inspection reports and completing regulatory assessments.

For example, in the preapproval process, the inspection team is responsible for endorsing the complete Establishment Inspection Report (EIR) package within 45 days of inspection close. Where the inspection results in an initial VAI or OAI recommendation, OPMA completes the final classification within 45 days of receiving both the complete EIR package and the establishment’s written response to Form FDA 483 observations, or by the applicable application-related due date, whichever is sooner.

For postapproval inspections, the document provides for completion of the EIR package within 45 days of inspection close, followed by the final assessment and recommendation by OPMA within the following 45 days. Follow-up actions are then initiated within the subsequent 10-day period.

These timelines are internal operating arrangements for FDA offices. They should not be interpreted as new statutory response deadlines imposed on manufacturers.

FDA Inspections and potential drug shortages

Another operational aspect addressed in the document is communication about potential disruptions to drug production and distribution.

During surveillance and for-cause inspections, investigators who become aware of activities that could affect ongoing production or distribution are expected to ensure that CDER’s Drug Shortage Staff is promptly notified.

The inspection team should also request that the establishment inform the Drug Shortage Staff of potential decisions that could affect production or distribution.

This provision connects inspection findings with the agency’s wider responsibility for monitoring medicine availability. It highlights that inspection-related information may have implications beyond the compliance status of an individual manufacturing facility.

What ConOps 2.0 means for pharmaceutical manufacturers

ConOps 2.0 does not introduce new CGMP technical requirements. Its significance lies in how the FDA organises and uses information when evaluating manufacturing facilities.

For manufacturers supplying the US market, several practical considerations follow.

First, companies should be prepared for remote information requests and assessments as part of the wider regulatory evaluation process. The ability to provide complete, accurate and well-organised records remains important even when an on-site inspection has not yet been scheduled.

Second, inspection outcomes from EU, UK and Swiss regulatory partners should be considered part of the wider FDA compliance picture. Manufacturers operating internationally should maintain consistent oversight of inspection findings, corrective actions and their closure status across different jurisdictions.

Third, companies preparing marketing applications should recognise the closer integration between application quality assessment and facility inspection. Information about manufacturing processes, facilities, validation and quality systems may influence the decision on whether a PAI or RRA is required.

Finally, the clarified internal workflows and timelines make the quality and timeliness of responses to inspection findings particularly important.

A more integrated approach to FDA facility inspections

The updated ConOps reflects the FDA’s move towards a more integrated approach to human drug facility evaluation and inspection. Rather than treating application review, on-site inspections, remote assessments and information from international regulatory partners as separate activities, the framework connects them within a coordinated operating model.

For manufacturers, the practical message is that regulatory oversight increasingly draws on a broader set of information sources. An inspection by an FDA-recognised international partner, a remote records assessment or information submitted during an application review may all contribute to the agency’s understanding of a facility’s compliance status.

The revised framework therefore reinforces the importance of consistent quality systems, reliable documentation and effective management of inspection outcomes across the entire manufacturing network.

Download the FDA document