FDA takes risk-based approach to PAIs
This article was originally published in The Gold Sheet
Executive Summary
FDA is taking a more coordinated risk-based approach to pre-approval inspections that the agency outlined in 1compliance program guidance manual 7346.832, which took effect May 12
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FDA is taking a more coordinated risk-based approach to pre-approval inspections that the agency outlined in 1 compliance program guidance manual 7346.832, which took effect May 12. If any of nine risk-based criteria listed on Page 3 of the manual are met, a priority pre-approval inspection is required. Many of the criteria involved firsts: first time for the facility or the applicant, new molecular entity, new or especially challenging manufacturing process. Others involve known risks such as animal-sourced ingredients or drugs with narrow therapeutic indices. Under the new approach, pre-approval inspections won't necessarily cover all aspects of a facility, as they did in the past. Instead, they will address some or all of three objectives, depending on the specific risks involved. Objective 1, readiness for commercial manufacturing, is subdivided into five areas: investigations; raw material handling; cross-contamination; standard operating procedures; and scale-up and process validation. Objective 2 is conformance to the application and objective 3 is data integrity. Attachment C of the document gives a flow-chart to help FDA decide which objectives to address in an inspection. The decision depends in part on the new drug product's profile, and how related it is to the profiles of drug products already made at the site. By profile, FDA is referring to the type of manufacturing process or dosage form involved. The manual also calls for "knowledge management" activities, in which review staff share their knowledge about the product with field staff who inspect the facility. The manual also notes that the scope of inspections can change depending on inspectional findings. |