GXP

The Long Awaited Revision 2 to EU Annex 1

Document Organization The following table identifies the various formats of the 2008, 2017 and 2020 versions of Annex 1. At first glance, it may appear that the revisions are shorter than the original Annex, the revisions are actually more detailed.  Many of the individual sections of the 2008 version have been grouped into larger sections in the revisions. CHANGES IN THE 2020 ANNEX REVISION Scope The scope of these documents has been changed to reflect that the Annex applies to Manufacture of Sterile Products, rather than the Manufacture of Sterile Medicinal Products.  This can be...

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