
Reprinted from PHARMACEUTICAL ENGINEERING®
The Official Journal of ISPE
July/August 2011, Vol. 31 No . 5
www.ISPE.org
©Copyright ISPE 2011
The ISPE GAMP
Community of
Practice (COP)
delivers its
model of
the revised EUROPEAN
GMP Annex 11
Computerised
Systems and
consequential
change
of EU GMP
Chapter 4
Records.
Annex 11 Interpretation
ISPE GAMP POLICEMAN Annex eleven
Interpretation
by simply Winnie Cappucci, Chris Clark simon, Tim Goossens, and
Sion Wyn
Capital t
Introduction
his interpretation from the revised Annex
11 requirements has been made
by a key GAMP COP Task Group, and
examined by the GAMP COP Council
and people of GAMP Regional Guiding
Committees.
The GAMP COP feels that there is practically nothing in the revised Annex 14 – in the event interpreted in a pragmatic and reasonable way – which should
cause key concern or problems to the regulated firm that was complying together with the previous Annex 11, and usually following good
practice because defined in GAMP a few and affiliated
key Good Practice Guides. The revised Annex
11 retreats into a risk based approach, and is lined up
with current industry good practice.
There is also a risk of controlled companies and
their suppliers over-analysing thorough wording
(either new or perhaps changed) in extreme details, looking for nuances and distinctions not meant by the experts of the rules.
The GAMP POLICE OFFICER advocates a feeling of perspective and balance, and avoiding virtually any unnecessary over-reaction to a smart and sensible piece
of regulation.
Review
The European Commission (EC) has released
a new version of EUROPEAN UNION GMP Annex 11 Computerised Systems, and consequential modification of EU GMP Section 4 Documentation. These will
come into operation by 30th June 2011.
Annex 11 continues to be revised in answer to the
elevated use of computerised systems as well as the
increased complexity of these systems. The Annex defines EUROPEAN requirements intended for computerised devices, and is applicable to all forms of computerised
devices used as part of GMP controlled activities.
EU GMP Chapter four requirements about generation, control, and retention of paperwork
have been revised in the lumination of the increasing
use of electronic documents in the GMP
environment, and in the light of the Annex 11
modification.
Primary draft revisions had been produced
for community consultation in April 08. There
was significant sector feedback, which include
substantive and detailed responses from the
ISPE GAMP Community of Practice. Most of
the problems raised by GAMP POLICEMAN have been
resolved in the final revisions. The most significant aspects of the revisions are: • Risk based approach to validation and operational controls • Harmonization with current industry very good
practice
• Clarification with the acceptability of electronic
information and autographs
Quality Risikomanagement
A significant conjunction with the revised Annex
is known as a new clause on top quality risk management,
which states:
Risk management should be used
throughout the lifecycle of the computerised system considering patient safety, data sincerity and product quality.
Within a risikomanagement system, decisions on the degree of validation and data integrity regulates should be based on a
validated and written about risk evaluation
of the computerised system.
This kind of risk management centered thinking, targeted
on sufferer safety and product quality, and structured
on good product and process understanding, is
the key to a right interpretation and understanding of the needs in this rules, July/August 2011 PHARMACEUTICAL ANATOMIST
1
Annex 11 Presentation
and how ideal controls to satisfy the requirements needs to be applied by regulated businesses. The revised Annex
likewise states that regulated firms should be able to warrant their standards, protocols, acceptance criteria, procedures and documents based on all their risk examination.
Raise the risk management approach adopted is very much in
line with ICH Q9...
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