Workflow Management in the Batch Record Review Process

Abstract

The review of Batch Records creates a story of the materials, manufacturing, and packaging involved in the production of biopharmaceuticals. The Master Batch Record details who, when, where, and how each process stage is carried out and how much of a product is produced. Most pharmaceutical companies need help to check batch data in time to provide medications to clients. However, a prolonged processtime affects how quickly goods must be made available to the public. As a result, reviewing batch records is a laborious process that mainly occurs afterward. For the manufacturing purification processes of a chromatography column, viral inactivation filtration, viral filtration, ultrafiltration, diafiltration, and bulk filling for a high cholesterol drug, this project assesses the viability of an incremental batch record review in real time. The DMAIC technique was used in this project's study to show how the queue time is decreased. The value-added time is increased, and other advantages. Key Terms ⎯ Batch Record Review, Lead Times, Process Improvement, Workflow.