"A Methodology to Activate the Role of Architectural Design in Quality Risk Management in Pharmaceutical Plants Essay

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Introduction The pharmaceutical industry is regarded as one of the strategic industries in many countries. In addition to providing self-sufficiency in pharmaceutical products, this industry sometimes constitutes an economic back bone to exporting countries. The design of pharmaceutical factory buildings impacts people and the surrounding environment. Accordingly, design reviews and design management of pharmaceutical plants is necessity to limit the risks of negative impact . Failur of architectural design in achieving safety requirements could lead to rehabilitation of factory buildings in addition to financial and material waste. Pharmaceutical factories are characterized by a variety types of risks. The procedures that define system efficiency are identified as Qualification & Validation Processes, and are applied to all the phases of the project including the architectural design phase. This pauses the question of : How can architectural design contribute in managing risks in pharmaceutical plants? The focus of this study addresses the above mentioned question, by determining how to direct architectural design to become a part of a quality risk management processes of pharmaceutical factories. Design considerations, based on specifications of the industry and on the study of contemporary factory models currently operating in Egypt, aim to review risks produced and allocated in certain production lines and to determine the possibility of reducing these risks by proper initial design that integrates good practice with continuous risk control techniques. Risk management processes do not rely on architectural design. Solely, risk management represent coordination procedures that run among various departments and agencies responsible for the industry. The research highlights the role of architectural design as one of the procedures

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