omar
Reprinted from PHARMACEUTICAL ENGINEERING®
The Official Magazine of ISPE
July/August 2011, Vol. 31 No. 4 www.ISPE.org ©Copyright ISPE 2011
The ISPE GAMP
Community of
Practice (COP) provides its interpretation of the revised EU
GMP Annex 11
Computerised
Systems and consequential amendment of EU GMP
Chapter 4
Documentation.
Annex 11 Interpretation
ISPE GAMP COP Annex 11
Interpretation
by Winnie Cappucci, Chris Clark, Tim Goossens, and
Sion Wyn
T
Introduction
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
Committees.
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.
Overview
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
The Official Magazine of ISPE
July/August 2011, Vol. 31 No. 4 www.ISPE.org ©Copyright ISPE 2011
The ISPE GAMP
Community of
Practice (COP) provides its interpretation of the revised EU
GMP Annex 11
Computerised
Systems and consequential amendment of EU GMP
Chapter 4
Documentation.
Annex 11 Interpretation
ISPE GAMP COP Annex 11
Interpretation
by Winnie Cappucci, Chris Clark, Tim Goossens, and
Sion Wyn
T
Introduction
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
Committees.
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.
Overview
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