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New EU GMP Annex 11:


Project Phase

Operational Phase

Table 1: Risk based Approach

Table 2: Suppliers and Service Providers

Table 3: Comparison of Annex 11 versions

Check Your Knowledge






The table below represents the question part of the Excel file, please ask for the complete file with answers, automatic score and evaluation.
By the way, for those interested in Excel, the File will demonstrate multi stage conditional formatting and validity check on data input and many other features which can advantageously be used to render an Excel file GMP-compliant.

Please click on the screenshots below to enlarge or click » here [150 KB] to get the table as PDF-file in a better resolution…

Example of answer evaluation, demonstrating conditional formatting