Title: Integration of manufacturing strategy and process validation for pharmaceutical industries: a case study

Authors: M. Reza Abdi, Jose Repolles

Addresses: School of Management, Bradford University, Emm Lane, Bradford, West Yorkshire, BD9 4JL, UK. ' School of Management, Bradford University, Emm Lane, Bradford, West Yorkshire, BD9 4JL, UK

Abstract: Safety of patients should be considered as the key element for production planning in pharmaceutical industries. Compliance with stringent regulations from regulatory agencies to guarantee quality and safety drugs, has been recognised by all pharmaceutical companies. Accordingly, a process validation strategy is required to optimise manufacturing processes, cleaning validation and equipment qualification while gaining routine flexibility. In this paper, an integrated approach is developed to link a pharmaceutical manufacturing strategy with its process validation in order to optimise the validation efforts through using a product-equipment cleaning matrix. Product selection for the next validation stages is derived by using a multi-criteria decision making model. In particular, an Analytical Hierarchy Process (AHP) model is proposed to analyse product candidates for validation through a case study whilst considering the critical decision elements.

Keywords: pharmaceutical industries; process validation; manufacturing strategy; regulatory agencies; product selection; multi-criteria decision making; MCDM; analytical hierarchy process; AHP; production planning; patient safety; drug safety.

DOI: 10.1504/IJCAT.2008.020336

International Journal of Computer Applications in Technology, 2008 Vol.32 No.2, pp.110 - 117

Published online: 18 Sep 2008 *

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