Changing paradigms for batch record review in pharmaceuticals to drive real time product disposition

Abstract

The review of batch records required to release products to customers on time presents a challenge for the majority of pharmaceutical companies. A slow process time, however, impacts the speed with which products need to be released into the market. This makes the review of batch records a tedious labor that mainly occurs afterwards.

This thesis evaluates the feasibility of an incremental batch record review in real time for the manufacturing processes of blending, coating—laminating, and slitting for hormone therapy patches at Noven Pharmaceuticals, Inc. The study for this thesis uses the fundamentals of the Lean Six Sigma methodology to demonstrate the reduction in queue time, the increase in value-added time, plus other benefits.

The goal of this study has been achieved, which has led to a proposal to make the batch record review in real time a permanent procedure for the production of hormone therapy patches at Noven Pharmaceuticals, Inc.