PQLI Engineering Controls and Automation Strategy |
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| Authors: | Ray Bolton Stephen Tyler |
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| Institution: | (1) AstraZeneca, Hazelwood House, Tytherington Business Park, Tytherington, SK10 4XR, UK;(2) Abbott Laboratories, 1401 Sheridan Rd., North Chicago, IL 60064, USA |
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| Abstract: | This paper discusses the development of engineering controls and automation strategy required to practically implement a Control
Strategy within a Quality by Design environment. It describes the relationship to the ISPE PQLI Control Strategy model, and
covers operating philosophy, record keeping, data management, and alarm strategy. Engineering and automation controls may
include measurement technologies for equipment parameters (off-line, at-line, in-line or on-line), univariate or multivariate
process models and control models, engineering or plant procedural controls and automation systems. Concepts from ANSI/ISA
S95 standards are applied.
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| Keywords: | PQLI Design space Control strategy Critical quality attribute Critical process parameter Knowledge space PAT Product and process knowledge Process model Control model |
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