Reprinted from PHARMACEUTICAL ENGINEERING®
The Official Journal of ISPE
July/August 2011, Vol. 31 No . 5
©Copyright ISPE 2011
The ISPE GAMP
the revised EUROPEAN
GMP Annex 11
of EU GMP
Annex 11 Interpretation
ISPE GAMP POLICEMAN Annex eleven
by simply Winnie Cappucci, Chris Clark simon, Tim Goossens, and
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
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
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
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
• Clarification with the acceptability of electronic
information and autographs
A significant conjunction with the revised Annex
is known as a new clause on top quality risk management,
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
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...
Australia faced the risk of communism after WWII ended in 1945. The danger was known as the Red Nuisance which was due to all the disputes in Asia and…...
Question one particular: What Managing, Organization, and Technology Concerns Should The chrysler Have Investigated When Selecting Whether to Outsource to Tcs? Composition - 420
Management Problems One of the main managing issues that is critical in outsourced workers is whether The chrysler wants rigid management control for day-to-day activities. By simply outsourcing to…...
Tactical Management Upon ITC's e-Chaupal This task report is focused on the strategies of ITC to get spreading in rural industry rapidly| 10/18/2012 Job 2012…...
Course: Bank Administration & Finance Chapter 5: Managing and pricing non-deposit liabilities Questions & Problems 1 ) Compare and contrast Fed funds deals with RPs?…...
Tourism and Food Systems Within Greece Portugal is one of the planet's most well-known tourist destinations, ranking in the planet's top 20 countries. Greece is situated in southern The…...
Inventory Systems Summary QRB/501 September 21st, 2010 Products on hand Systems Synopsis Products on hand systems are used in different businesses today being a…...
Dorothy Edith Smith " Feminist Perspective Theory and Institutional Ethnography” 1926- Dorothy E. Cruz was born in North Great britain in 1926. Dorothy Elizabeth. Smith offers lived an extended…...
Explain and seriously discuss TWO of the traditional theories of work. In your crucial analysis comment on the relevance of the hypotheses to today's society (1, 000 to at least…...
THE CATHOLIC UNIVERSITY OF EASTERN AFRICA FACULTY OF COMMERCE OFFICE OF MARKETING AND MANAGEMENT PRODUCT TITLE: ADVERTISING PLANNING AND CONTROL TASK: Analyze the importance of…...
Nigeria’s Credit cards and Payments Industry Growing Opportunities, Trends, Size, Individuals, Strategies, Products and Competitive Panorama Essay
Nigeria's Cards and Payments Sector: Emerging Possibilities, Trends, Size, Drivers, Approaches, Products and Competitive Landscape: Order report by calling marketreportsstore. com at +1 888 391 5441 OR give an email on [email protected]…...