Organisations are continuously seeking for strategies to improve operations and gain competitive advantage. Maintenance tends to be a key management issue for many industrial companies. Maintenance management, being an integral part of manufacturing, can influence competitive companys‟ priorities, such as cost, quality and flexibility, and, hence, business strategy directly. The pharmaceutical industry also faces some unique challenges such as increasingly stringent safety and quality regulations, the effect of innovations in medical science and healthcare and a complex and costly design-to-market process (from product concept and development to market delivery). The industry is also going through turbulent times as it has to cope with challenges common to many other industries, how to deal with increasing competition, hold down costs, and expand. Regulatory compliance is one of the significant industry drivers for pharmaceutical companies. Regulations are enacted by government authorities to ensure public health and safety. The focus of regulation is on quality assurance and control in all areas such as receiving, manufacturing, storing, packaging, despatching and delivering. Apart from the required quality and safety checks, the regulations also mandate extensive record keeping of procedures, processes and systems. This treatise will investigate the maintenance management system of a pharmaceutical company and compare it to best practices. The true name of the pharmaceutical company that will be researched will not be disclosed for confidentiality reasons, instead it will be called My Pharmaceuticals. The company is based in Port Elizabeth. The research consists of a preliminary study to identify the problem areas in the maintenance management system within the company. A literature review of best practices in maintenance management systems combined with an investigation into the best pharmaceutical practices in maintenance management systems and regulatory controls are investigated and a model will be proposed to improve the current situation at the company.

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University of Macau / Institute of Chinese Medical Sciences

University of Macau / Institute of Chinese Medical Sciences