Topics: Risk management, Requirements analysis, Business continuity planning Pages: 24 (5438 words) Published: October 24, 2013
The Official Magazine of ISPE
July/August 2011, Vol. 31 No. 4
©Copyright ISPE 2011

Community of
Practice (COP)
provides its
interpretation of
the revised EU
GMP Annex 11
Systems and
Chapter 4

Annex 11 Interpretation

by Winnie Cappucci, Chris Clark, Tim Goossens, and
Sion Wyn



his interpretation of the revised Annex
11 requirements has been produced
by a core GAMP COP Task Team, and
reviewed by the GAMP COP Council
and members of GAMP Regional Steering
The GAMP COP believes that there is nothing in the revised Annex 11 – if interpreted in a pragmatic and reasonable way – that should
cause major concern or problems to any regulated company that was complying with the previous Annex 11, and generally following good
practice as defined in GAMP 5 and associated
key Good Practice Guides. The revised Annex
11 adopts a risk based approach, and is aligned
with current industry good practice.
There is a risk of regulated companies and
their suppliers over-analysing detailed wording
(either new or changed) in extreme detail, looking for nuances and distinctions not intended by the authors of the regulation.
The GAMP COP advocates a sense of perspective and balance, and avoiding any unnecessary over-reaction to a sensible and reasonable piece
of regulation.

The European Commission (EC) has announced
a new revision of EU GMP Annex 11 Computerised Systems, and consequential amendment of EU GMP Chapter 4 Documentation. These will
come into operation by 30th June 2011.
Annex 11 has been revised in response to the
increased use of computerised systems and the
increased complexity of these systems. The Annex defines EU requirements for computerised systems, and applies to all forms of computerised
systems used as part of GMP regulated activities.
EU GMP Chapter 4 requirements on generation, control, and retention of documents

have been revised in the light of the increasing
use of electronic documents within the GMP
environment, and in the light of the Annex 11
Initial draft revisions had been released
for public consultation in April 2008. There
was significant industry feedback, including
substantive and detailed comments from the
ISPE GAMP Community of Practice. Most of
the issues raised by the GAMP COP have been
addressed in the final revisions. The most significant aspects of the revisions are: • Risk based approach to validation and operational controls • Harmonization with current industry good
Clarification of the acceptability of electronic
records and signatures

Quality Risk Management
A significant addition to the revised Annex
is a new clause on quality risk management,
which states:

Risk management should be applied
throughout the lifecycle of the computerised system taking into account patient safety, data integrity and product quality.
As part of a risk management system, decisions on the extent of validation and data integrity controls should be based on a
justified and documented risk assessment
of the computerised system.

This risk management based thinking, focused
on patient safety and product quality, and based
on good product and process understanding, is
the key to a correct interpretation and understanding of the requirements in this regulation, July/August 2011 PHARMACEUTICAL ENGINEERING


Annex 11 Interpretation
and how appropriate controls to meet the requirements should be applied by the regulated companies.The revised Annex
also states that regulated companies should be able to justify their standards, protocols, acceptance criteria, procedures and records based on their risk assessment.
The risk management approach adopted is very much in
line with ICH Q9...
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