Re-interpreting Validation

S V Lord, T J McCarthy, H A Aleem, Y Zhao, Paul Sharratt

    Research output: Contribution to journalArticlepeer-review


    This paper briey describes the current approach to validation in good manufacturing practice
    (GMP) and postulates that the main difculty with the process is determining how much validation is
    enough. It asserts that the current methodology is focused on documentation rather than verication, and
    furthermore that the inherent problems of document management are inhibiting resolution of the main
    difculty. The paper argues that a data-driven approach instead of a document-driven approach to
    information management has the capability of removing the document management problems and thus
    enabling an improvement in verication. It further argues that such an approach is timely because of the
    increased use of computer applications and databases in design, construction, commissioning and operations,
    and available standards and implementations. It is also timely because of the recent interest of the US
    regulatory authority (FDA) in the regulation of electronic records [1]. Furthermore, a migration path exists
    where documents can be produced as necessary but no longer are the master information source.
    Opportunities for further research are identified.
    Original languageEnglish
    Pages (from-to)287 - 293
    Number of pages7
    JournalProceedings of the Institution of Mechanical Engineers, Part E: Journal of Process Mechanical Engineering
    Issue number4
    Publication statusPublished - Dec 2003


    • pharmaceutical process
    • validation qualification
    • verification
    • good manufacturing practice


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