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The ISPE Baseline® Guides were initiatives mobilized after a team of executives from all around the industry came together. We listened to what the regulators wanted and needed. We created a solution without the barriers of politics and lobbying efforts, and we delivered.

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Purdue Pharma LP, USA

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Pharmaceutical Engineering Archives

September/October 1996
Volume 16, Number 5

Theme: Materials Handling


Table of Contents

Articles

Pharmaceutical Engineering Interviews William G. Thien
by William G. Thien
An interview with the Vice President, Health Services of Walgreen Co.
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Strict Adherence to a Defined Protocol: A Key to Eliminating Difficult Production Problems
by Charles L. Rosen, PhD
This article describes a computer ready diagnostic protocol based on inductive logic that is able to find the cause of difficult production problems even when the standard deductive logic techniques of traditional problem solving fails.
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GAMP 96 Expands on Original Document
by Pamela A. Jones
(GAMP) Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture update.
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The Application of Ergonomics to Barrier/Isolation Systems
by Hari Floura
This article outlines a design methodology for the application of ergonomics to barrier/isolation systems.
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Schering-Plough Automates with a Vision to the Future
by Ann Donlon
This article outlines how a distributive control system was incorporated in a fermentation plant expansion ensuring full compliance with regulatory validation criteria.
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'Cone Valve' Intermediate Bulk Container Systems in Automated, Multi-Level Secondary Pharmaceutical Manufacturing
by Dave DiProspero & Dave Drew
Use of cone valve intermediate bulk container systems in multi-level manufacturing facilities can offer automation, containment and segregation reduction to the solid dose form manufacturer.
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Process Validation of Solid Oral Dosage Forms
by Scott Bozzone, Adel S. Maximos & K.S. Murthy
Process validation is an undertaking through which the process performance is monitored and evaluated in order to ensure that the process will yield a consistently high quality product through repeated commercial batch production.
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