FDA issues guidance on alternative tools for assessing facilities in pending drug applications Read More..

In the guidance FDA describes use of alternative tools to assess manufacturing facilities identified in NDA, ANDA, or a BLA. FDA conducts PAI (Preapproval) or a PLI (Prelicense) to ensure facility can perform manufacturing in conformance to the cGMP requirements and confirm accuracy of data submitted in application. FDA may use alternative tools in lieu of an inspection or to support a PAI or a PLI. This guidance does not apply to other drug inspection programs including:

• • Post approval inspections
  • Surveillance inspections
  • Follow-up and compliance inspections (e.g., for-cause inspections)
  • Bioresearch monitoring inspections

FDA may use alternative tools to inspection to support a PAI or PLI due to any or a combination of following factors:

• • facility has a drug inspection history by FDA or a trusted foreign regulatory authority
  • risks or applicable facility operations can be sufficiently assessed by alternative tools
  • product addresses an urgent need
  • inspection is not possible due to travel restrictions (such as in a Pandemic)

However FDA does not intend to grant requests from applicants or facilities for FDA to use alternative tools. FDA may initiate a Remote Regulatory Assessment (RRA), an examination of facility and/or its records to evaluate compliance with applicable FDA requirements. RRA may be conducted by calling for records from a facility, conducting a Remote Interactive Evaluation (RIE). FDA may seek a teleconference or a virtual meeting for clarification of the records if the facility’s response does not sufficiently address FDA’s request. Following an RRA, a written list of observations (if any) is presented by FDA and facility should submit any responses or corrective actions to FDA within 15 days. The guidance Conducting Remote Regulatory Assessments Questions and Answers (July 2022) gives recommendations on how to prepare for an RRA.

• Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications
• Conducting Remote Regulatory Assessments Questions and Answers (July 2022)