Monday, 20 September 2021 14.00 - 15.30 h
New GMP-Guide on Qualification Approved by the ASTM
In a two-page document the ASTM announced, that the document is now approved,and introduces it by seven questions:
The Guide concentrates on reducing IQ and OQ activities through a risk andscience based approach, which also takes into account supplier documents. Inaddition, the society also considers Good Engineering Practice (GEP) to play animportant role for reducing cost.
Interestingly the ASTM compares its Guide with regulatory guidelines. It alsomentions the US Food & Drug Administration (FDA), which, according to ASTM,supposedly knows the document. There are no comments on the guide from Europeanauthorities though.
Moreover, the concept is also considered as usable for computer validation. Itis mentioned, though, that it will be incorporated in GAMP 5.
Taking full advantage of the concept for qualifications is supposed to allowcost reductions of up to 50%.
To find details on the Guide please visit the ASTM Website.
The following programmes by the European Compliance Academy(ECA) also concentrate on validation / qualification: