FDA: Updated Compliance Program for Preapproval Inspections
The FDA has revised its Compliance Program 7346.832, “Preapproval Inspections”. The updated program describes the planning, conduct and evaluation of preapproval inspections (PAIs) for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs). The program is effective 10 August 2026.
The four familiar inspection objectives remain unchanged: Readiness for Commercial Manufacturing, Conformance to Application, Data Integrity Audit, and Commitment to Quality in Pharmaceutical Development.
A key change concerns the coverage model for the first inspection objective, “Readiness for Commercial Manufacturing”. This objective has been divided into five sub-objectives. Only some of these sub-objectives are mandatory for every inspection, while the others are covered depending on identified risk factors. Before the inspection begins, the Integrated Quality Assessment (IQA) team communicates these risk factors to the inspection team in writing.
In addition, the revised program updates the risk-based selection of manufacturing facilities for inspection and the collaboration between the FDA units involved in application assessment and inspection activities.
Prelicense and preapproval inspections of CDER-regulated biological product manufacturers are covered by the separate Compliance Program 7346.832M.
Source:
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
