CHANGING PARADIGMS FOR BATCH RECORD REVIEW IN PHARMACEUTICALS TO DRIVE REAL TIME PRODUCT DISPOSITION – PDF Download

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

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

The goal o f 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 o f hormone
therapy patches at Noven Pharmaceuticals, Inc

 

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