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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






On January 3rd, 2011 the European Commission has published a risk based approach on computerised systems in GMP environments, the new

Annex 11 Computerised Systems

as part of the

The Rules Governing Medicinal Products in the European Union
Volume 4
Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use
» annex11_01-2011

The deadline for coming into operation is 30 June 2011.
By and large this annex 11 may be viewed as an equivalent to the US FDA 21 CFR11 » 21CFR11.

The new European 4 page document is considerably more detailed than the current annex 11 » anx11 with hardly 2 pages but much less voluminous than the intensively discussed draft from 2008 with 8 pages (» annex_11_consult_200804) Please refer to the attached table 3 for a comparison of the current annex 11, the 2008 draft and the annex 11-01-2011.

The annex 11-01-2011is subdivided in 5 chapters:
Project Phase
Operational Phase
with a total of 17 numbered sections.

Take 5 minutes to playfully check your knowledge on annex 11-01-2011:

» Request a free copy of the check from PharmAdvice available as a macro enhanced Excel file recording and evaluating your answers and indicating in colour what’s right or wrong and telling you why. Preview the 17 questions at the bottom of this text.

Download the PDF Version of this consideration » neweu_gmp_annex11_interpretation.pdf [773 KB]

The following consideration summarize the new annex 11 requirments and correlate them with other GMP requirements


The basic idea of the annex
“where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance.”
is almost literally transferred from the current annex 11.