Jul 14, 2021

Recent guidance from the US Food and Drug Administration on conducting remote evaluations of pharmaceutical facilities during the COVID-19 public health emergency requires careful consideration by drug and biologics manufacturers in terms of compliance, training and learning management.

The FDA guidance, issued in April 2021, lays out agency plans to conduct in-person inspections only for facilities considered high-risk, relying on remote interactive evaluations for moderate- and low-risk facilities and therefore increasing the amount of time between full-blown inspections for those facilities.

FDA investing in technologies to support remote inspections of drug facilities

Concurrently, FDA is transforming its data enterprise platforms and cross-program interoperability infrastructure to better support remote regulatory oversight efforts. The agency will utilize next-generation technologies and implement improvements under the planning and coordination of a new inspectional affairs council.

Given these technology and infrastructure investments by FDA, life sciences companies can expect the agency to rely on remote interactive evaluations and inspections for qualifying facilities at least for the duration of the coronavirus pandemic, and potentially for a longer duration.

Drug inspection programs subject to FDA remote interactive evaluations

The FDA guidance applies to drug inspection programs including:

  • Pre-Approval Inspections (PAI) and Pre-License Inspections (PLI) to assess whether facilities identified in marketing applications can perform manufacturing operations in conformance with current good manufacturing practices (CGMP);
  • Post-Approval Inspections (PAI) to determine whether specific pharmaceutical products as well as any changes to their manufacturing processes, process validation evaluations and marketing application changes do not deviate from CGMP or FDA application commitments;
  • Surveillance Inspections that assess overall manufacturing operations to mitigate risks to patients and consumers;
  • Follow-up and Compliance Inspections in cases where a quality or facility problem involving a specific drug arises; and:
  • Bioresearch Monitoring (BIMO) Inspections, which include inspections and data audits to monitor and evaluate how manufacturers conduct and report research regulated by FDA.

Key LMS and training considerations for drug and biologics manufacturers

As FDA relies more heavily on remote evaluations and inspections of drug and biologics facilities, affected life sciences companies will need to assess their current technology and data management processes, as well as ensure that adequate learning management system (LMS) tools are in place to support compliance and training requirements.

Some key issues that warrant manufacturers’ attention in light of FDA’s guidance on remote evaluations include:

  • Ease of use in terms of sharing remote access of data with FDA inspectors;
  • Ensuring effective employee preparedness for remote FDA evaluations, inspections and audits;
  • More crucial focus on data integrity as manufacturing and facility information is shared remotely;
  • Renewed focus on deviation management as well as corrective and preventative actions (CAPA) as FDA evaluation and inspection schedules are irregular.

Vanita Khatter is Regulatory Services Regional Manager at UL’s ComplianceWire LMS development division.

Related FDA regulatory and LMS resources:

Author

  • Vanita Khatter and Stewart Eisenhart

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