How to Reduce the Confirmation Period of Possible Critical Defects Detected During the Quality Assurance Acceptance Sampling Plan for Inspected Drug Product

Abstract

An Acceptance Sampling Plan, or ASP, is a Quality attributes assessment performed during the manual or automated inspection of Drug Products. After inspection, the inspected product then becomes an Inspected Drug Product, or IDP. During the ASP, if any critical defect is identified during inspection, it is segregated for further On the Floor Testing (OFFT) or Process Development (PD) evaluation for additional confirmation. The main focus of this project is how to reduce this confirmation period by implementing portion segregation during the inspection process and sending the defective unit(s) for further evaluation as soon as the portion is completed, instead of waiting for the culmination of the batch inspection process. This implemented modification in current standard operating procedures, reduces the wait period by performing the defect confirmation parallel to the on-line inspection process, thus avoiding delays in the product’s final disposition. Key Terms ⎯ acceptance sampling plan, critical defect, on-the-floor forensic testing, process development