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THE WBF BOOK SERIES--ISA 88 Implementation Experiences by The WBF

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CHAPTER 2

An Iterative Refinement Approach toward a Structured Recipe Design
Presented at the WBF European Conference, Barcelona, Spain, November 10–12, 2008, by
Ramayya KumarDirectorkumar@paperless-gmbh.comPaperless GMBH, Hirschstrasse 130,Karlsruhe, 76137 Germany

Abstract

This chapter is a case study within pharmaceutical sites that describes the application of ISA-88 and ISA-95 structures and methodology, in spite of the fact that these sites were using a vendor’s product that did not adhere to the standard terminology. An iterative refinement approach was taken while designing the implementation of recipes. Initially a library of process actions was developed for the enterprise. Each process action was comprised of a description, ...

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