The regulation of product quality information in the pharmaceutical manufacturing industry and its impact on information management

Mills, Mark (2011) The regulation of product quality information in the pharmaceutical manufacturing industry and its impact on information management. BSc dissertation, University of Portsmouth.

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    Abstract

    This research investigates the relationship between pharmaceutical manufacturers and the regulators who govern the industry. In particular, the research studies what quality critical information is gathered from production processes and how this needs to be regulated to ensure product safety and effectiveness. Two techniques have been used to explore this topic: Soft Systems Methodology (SSM) and Effective Technical & Human Implementation of Computer-supported Systems (ETHICS). The evidence gathered suggests that a risk-based approach to information management, along with a quality-by-design philosophy, satisfies the needs of product regulators, optimises pharmaceutical process efficiencies, and gives patients a reliably consistent medicine and delivery device.

    Item Type: Dissertation
    Departments/Research Groups: Faculty of Technology > School of Computing
    Depositing User: Jane Polwin
    Date Deposited: 03 Aug 2011 11:22
    Last Modified: 28 Jan 2015 11:41
    URI: http://eprints.port.ac.uk/id/eprint/4351

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