FDA issues draft guidance on alternative tools for facility assessments

The US Food and Drug Administration (FDA) has published draft guidance on how it intends to use alternative tools for assessing drug manufacturing facilities identified in pending marketing applications.

For example, the applications are New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), or a Biologics License Applications (BLAs).

Fundamentally, this approach will establish whether facilities meet applicable requirements for FDA approval and licensure decisions. The alternative tools will help the FDA to meet user fee goal dates and make timely application decisions.

The agency will consider alternative tools for an application’s facility evaluation, as appropriate and on a case-by-case basis, in advance or in lieu of an inspection or to support a pre-approval inspection (PAI) or a pre-license inspection (PLI).

In the draft guidance, the FDA stated it may use alternative tools to assess whether relevant facilities can perform the proposed manufacturing operations in conformance to the application and in compliance with applicable requirements, including the current good manufacturing practices (cGMP) requirements for drug manufacturing.

Assessing drug manufacturing facilities using alternative tools

The FDA stated in the guidance that all manufacturing, packaging, and control sites for drug substance and drug product facilities are expected to be ready for inspection at the time of application submission. This will ensure these facilities are prepared on the occasion that the FDA chooses to inspect and/or to use an alternative tool at any point in the application assessment cycle.

If there is insufficient information to determine the acceptability of a facility, the guidance noted than an inspection will be required to address the concerns. In these cases, the FDA will communicate this determination in application milestone meetings, action letters, postaction letters, and/or communications regarding scheduling of the inspection, as appropriate.

It was also highlighted that a facility should submit any responses or corrective actions within 15 US business days for consideration in the application assessment. Responses received after this time may be deferred for further assessment in the next application assessment cycle.

FDA inspections and remote resources

Having gained experience in virtual interactive technologies, the FDA acknowledged that by supplementing an inspection with remote resources, these tools have potential benefits for addressing technical and logistical needs in certain circumstances.

As a result, FDA wrote that it intends to make the expertise of remote personnel available to on-site FDA inspection teams to support PAIs and PLIs and to facilitate regulatory decision-making and timely application decisions. This will help the agency to maintain operational flexibility through enhanced efficiency and transparency.

Additionally, the guidance noted that the FDA does not plan to authorise requests regarding the use of alternative tools.

Comments on the FDA’s draft guidance can be submitted here until 21 November 2023.