The FDA (Food and Drug Administration) has finalized its guidance on using alternative tools for routine inspections of drug manufacturing facilities. The measure aims to optimize the new product approval process by using remote methods to assess compliance with Good Manufacturing Practices (GMP).  

The new FDA guidance, “Final Guidance on Alternative Inspection Tools,” details how the agency can use a range of remote methods to conduct pre-approval inspections (PAIs) and pre-license inspections (PLIs). The news is particularly relevant because it formalizes practices that intensified during the COVID-19 pandemic. 

The alternative tools mentioned include: 

• Remote Regulatory Assessments (RRA): Remote assessment of a company’s records and documentation. 

• Remote Interactive Evaluations (RIE): Facility evaluations that may involve the use of video and real-time communication technology. 

• Information Exchange via Mutual Recognition Agreements (MRA): Requesting data from partner regulatory agencies abroad. 

GRP emphasizes that the guidance applies specifically to pending NDA, ANDA, and BLA applications, as well as their supplements. It’s important to note that it does not apply to post-approval, surveillance, or “for-cause” inspections. 

The final document, which includes some changes from the September 2023 draft, clarifies important points: 

• Response Timelines: The FDA now specifies a timeline of 15 business days for a company to respond to record requests, or 30 days when a translation is needed. 

• Declining Remote Tools: The agency clarifies that declining to use remote resources may prolong the decision on an application. 

• Global Application: The alternative tools apply to both US and international facilities. 

• Observation Reporting: Observations made during an RRA will be communicated in writing, while those made during an inspection that includes a remote subject matter expert (SME) will be detailed on a Form 483.