Presents a literature review relating to the issue of total quality management (TQM) in the pharmaceutical industry.
Written in 2004; 2,267 words; 17 sources; APA; $ 70.95
Paper Summary:
Good manufacturing practices (GMP) are considered part of the quality control system for companies producing pharmaceutical products. GMP principles aim to ensure the regular production for products that conform to the health standards required from regulatory bodies. GMP provides the general basics to determine the minimum acceptable requirements for the production at good products, covering all the activities related to the production process. This paper hypothesizes that, although ISO 9000 certification, which is the world-wide quality management and quality assurance standard, is not required for pharmaceutical companies, only those with a company culture mature and ethical enough to implement TQM successfully will be able to successfully implement GMP (industry-specific standard). There has been a great deal of confusion concerning whether being in compliance with the pharmaceutical GMP would successfully lead to obtaining ISO certification with minimum changes and costs, or whether achieving ISO certification is going to be a long and expensive road. This paper hypothesizes that the ultimate success of a company's ISO program will not depend solely on how well-defined its quality system is, but rather its commitment to maintaining GMP.
From the Paper:
"In general, this is mainly because the companies have not taken seriously enough the fact that TQM involves a cultural change for the organization. It creates a shift in power between boss and employee. Many managers, especially those who were inadequately trained, have seen employees as accessories to their jobs - as people to be told what to do. People who are disempowered often fail to take initiative in identifying process or sub-component faults. According to the laws of human nature, employees treated this way will leave a great deal of work to be handled by management. According to the theories of TQM, managers have to learn to support, encourage and listen."
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