GAMP 4, the GAMP Guide for Validation of Automated
Systems, has been released in December in Amsterdam. The guide aims to assist
companies in the healthcare industries to achieve validated and compliant
automated systems. It provides guidance to the suppliers of those automated
systems on their development and maintenance by following good practice, and
assists the suppliers in producing the necessary documentation required to
support validation. GAMP 4 is a significant advance on previous
versions of this widely accepted guidance on validation of automated systems.
The complete document has been revisited and refined to reflect current
regulatory expectations and good practice. It has been considerably enhanced and
restructured, following principles and recommendations defined by the GAMP
Industry Board To order GAMP 4, please visit http://www.ispe.org/
The gamp 3 guide is produced by the GAMP Forum which was
established by representatives from major international companies, to interpret
and improve understanding of regulations regarding the use of automated systems
in pharmaceutical manufacturing.It helps users understand the
requirements for validation of an automated system and the level to which the
validation should be performed. It helps suppliers ensure that systems are
developed according to good practice, and to provide documentary evidence that
their system meet the agreed specification.
GAMP 3 is considerably revised and enhanced compared to the
previous version, GAMP 2.0 / 96. It includes new material and has been
reconstructed for ease of use.
Volume 1, Part 1 - User Guide Outlines the requirements
for validation or automated systems and describes the role of the pharmaceutical
user organisation in this process.
Volume 1, Part 2 - Supplier Guide Describes the quality
requirements for a supplier of automated systems to the pharmaceutical industry
and describes the proposed management system for such suppliers.
Volume 2, Good Practice Examples Contains Good Practice
definitions, and guidance on application of Good Practice to various
New Material includes guidance on:
Validation Planning User Quality & Project Planning
Revised Management Systems for Suppliers Revised Management Systems for
Process Control Systems Configuration Management Specification and
Testing of System Interfaces Good Documentation Practice Good
Engineering Practice Validation of Information Systems Validation of
Process Control Systems
A major addition is the GMA/NAMUR guidance on a
methodology for the management of projects for automated plant control on a
This Includes: Execution of Process Control Projects
subject to Validation Operation and Maintenance of Validated Systems (On
Going Validation) Validation Support by use of Control Systems Suppliers
of automated systems and their customers in the pharmaceutical industry will
benefit by adopting the principles defined in GAMP 3. Among thebenefits
accorded are improved visibility of projects to ensure delivery of projects on
time, on budget and to agreed quality standards. Use of GAMP 3 also brings a
common understanding of the purpose and process of validation as well as reduced
validation costs and timetables. In addition, it eliminates the need for costly
GAMP 3 has been endorsed by the Association of the British
Pharmaceutical Industry (ABPI) and the Pharmaceutical Quality Group of the
Institute of Quality Assurance.
For the development and implementation of new computer
systems used in the manufacture of drug products, the International Association
for Pharmaceutical Technology (APV) recommends GAMP 3 as the technical basis for
the contractual agreements between supplier and user.