Enhancement of Batch Review Report for Annual Product Reviews in the Pharmaceutical Industry

Abstract

The pharmaceutical industry is required to comply with various regulatory agencies which determine the industry capabilities for compliance and allow the marketing of their products. Regardless the regulatory agency one requirement that is common is the review of the batches that are manufactured and packaged, whether approved or rejected. The current process used to determine the batch status is delaying the process for the report submission. The project objectives were to reduce the cycle time along with an enhancement in the information provided within it. The Lean Six Sigma methodology, specifically the DMAIC tool, was used to accomplish these objectives. After a thorough review of the possible root causes it was determined that a new system to search the batches status was needed. Work instructions were developed and the personnel were trained. The project objectives were accomplished since the cycle time for the report preparation was reduced and the report accuracy was enhanced. Key Terms - APRs, Batch Review Report, CFR Part 211, Cycle time.