Abstract
For plants in the pharmaceutical environment, the general structure of the documentation according to the GAMP 5.0 model is advantageous, see also [1]. It describes how to define the basis of the user data, lists the individual documents in a system of planning. Then planning documents are refined, written in construction plans and specifications, according to which the isolator system is built. In the last section of the isolator construction these documents are consulted again to illustrate in the qualification, that there is a ready-made system that meets the customer requirements.
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References
Good Automation Manufacturing Practice. GAMP 5: A risk-based approach to compliant gxp computerized systems, International Society for Pharmaceutical Engineering (ISPE), 02–2008 (2008)
Krebsbach, T.: und F. Böttcher; Leistungsqualifizierung von Steriltest-Isolatoren. Pharm. Ind. 74(3), 469–476 (2012)
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Bässler, HJ., Lehmann, F. (2013). System Validation. In: Containment Technology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-39292-4_10
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DOI: https://doi.org/10.1007/978-3-642-39292-4_10
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