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GAMP5: Updated guidance on CSV
The Good Automated Manufacturing Practice (GAMP)
guides have for the last 10 years provided a universally
accepted approach for the development and use of
computerised systems within international Pharmaceutical
regulations. The guides are intended for users, suppliers
and regulators to the industry and are produced by the
International Society Pharmaceutical of Engineers (ISPE).
In March of this year the latest version 5 of the guide has
been released and includes some major revisions and
updates to the practical best practice found in version 4, in
this edition of ‘Call in for a Coffee’ we take a closer look.
Computer Systems Validation: Value added?
The new GAMP version 5 is built on the methodology
established in version 4, usually referred to as the V-model.
Succinctly, the V-Model approach is that at each step in the
lifecycle of a Computerised System the functionality and
behavior of the system(s) are verified and tested to
ensure conformance with original specification and
requirements.
In principle this is a simple concept but with increasing
complexity, inter-operability and integration such validation
projects have a sizable impact on the implementation
costs and efforts for the installation of new technology,
often validation is done with the aim only to fill a regulatory
requirement and this can lead to a negative perception and
a view that computer validation does not provide any value
added.
The challenge of ensuring patient safety, meeting
regulatory demands and providing business benefits has
deterred some manufactures, especially in regions where
regulation for computer systems validation does not exist or
is poorly understood. In addition the prevalence of legacy
systems and insufficient local resources to manage such
projects has lead to manufactures having little or no
verification of their systems.
No responsibility can be taken by the publisher or the contributors for action taken as a result of information provided or
opinions expressed in this publication. Readers are strongly recommended to take expert advice on particular situations.
Factorytalk Co., Ltd. All Rights Reserved.
In our experience, the benefits of validation is not only
demonstrated by the leveraging of regulatory requirements
to demolish trade barriers, but as a key tool for tracking and
ensuring successful and high quality delivery of Information
System. Some of the business benefits of the GAMP
approach are:
Reduction in cost of achieving compliance
Cost effective operation and maintenance
Enabling innovation and new technology
These factors can lead to a very effective return on
investment as long as the validation is not overdone and is
performed to industry accepted practices by experienced
and knowledgeable resources.
Core components
GAMP5 has been revised with strong reference to three
current focus areas for the industry and the US FDA’s 21st
Century Initiative:
Quality by Design
Process Understanding
Continuous Improvement
In addition the revision was conducted to align with new
documents and standards from PIC/S, ICH and the
American Society of Testing and Materials. GAMP5 aims to
implement these new initiatives at lower cost by:
Focusing attention on the highest impact
Applying risk management throughout the life cycle
Recognising configurable package design
Adopting flexible and scaleable ways of validation
Leveraging engineering and supplier activities
Good Practice: Where to Start?
GAMP5 states that a Quality Management System for
Information Systems should cover the entire life cycle and
be Risk Based- but what does this actually entail? And how
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to do this without overwork? Here we highlight three key
points for particular focus:
1. Risk Assessment – an evaluation of the threat to quality
and thus patient safety and should be made on scientific
knowledge of the system specifications, design and the
business process being supported. Based on the
assessed threat, the nature and level of control is
determined; thus reduced validation effort maybe justified.
GAMP5 outlines a 5 step process for Risk Management:
1) Perform initial Risk Assessment and determine impact
2) Identify functions with impact on safety and quality
3) Perform functional Risk Assessments to identify controls
4) Implement and verify controls
5) Monitor controls
2. Supplier Documentation - By utilising information,
templates and documentation from suppliers and
commissioning, a large reduction in duplication, inaccuracy
and efforts can be made over reproducing such information.
3. Change and Configuration Management – Change
Control is the critical record and mechanism for ensuring
that any changes of a system are made without affecting
the validated state. Any investment in validation will be
risked if Change Control is not maintained.
Change Control ensures that modifications are
authorized, documented, tested and approved prior to
implementation.
Configuration Management is the control and
documentation of the baseline system and upon which
Changes are controlled.
Conclusions & Considerations
Validation of Information Systems, either those already
implemented or prospective have a large impact on the
costs associated with the uptake of technology in
Pharmaceutical manufacturing. The validation of such
No responsibility can be taken by the publisher or the contributors for action taken as a result of information provided or
opinions expressed in this publication. Readers are strongly recommended to take expert advice on particular situations.
Factorytalk Co., Ltd. All Rights Reserved.
systems is not a necessary evil but rather a tool to
ensure compliance, reduced cost of operation and a
framework with which to manage projects. Experienced
resources and best practice techniques will ensure that
benefits are achievable and validation becomes with value
added.
Free Consultation
GAMP5 and CSV maybe new to some people and
customers may have questions; we will provide satisfying,
understandable answers.
Simply contact Factorytalk and “Call for a Coffee” for a
free consultation.
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