Abstract
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.
(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 language | English |
|---|---|
| Pages (from-to) | 287 - 293 |
| Number of pages | 7 |
| Journal | Proceedings of the Institution of Mechanical Engineers, Part E: Journal of Process Mechanical Engineering |
| Volume | 217 |
| Issue number | 4 |
| Publication status | Published - Dec 2003 |
Keywords
- pharmaceutical process
- validation qualification
- verification
- good manufacturing practice