omar

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...