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Dissertation/Thesis Abstract

Changing paradigms for batch record review in pharmaceuticals to drive real time product disposition
by Padrono, Blanca, M.S., California State University, Dominguez Hills, 2014, 143; 1525507
Abstract (Summary)

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.

Indexing (document details)
Advisor: Krivokuca, Milton
School: California State University, Dominguez Hills
School Location: United States -- California
Source: MAI 53/01M(E), Masters Abstracts International
Subjects: Engineering
Keywords: Batch record preview, Batch record review in pharmaceuticals, Product disposition in real time, Reducing cycle time, Streamlining batch record review in pharmaceuticals
Publication Number: 1525507
ISBN: 978-1-321-03291-8
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