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Good Autmated Manufacturing Practices
URL:
http://www.gamp.org/
GAMP 4 Released
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/
GAMP 3
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
systems.
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 large scale.
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
retrospective validation.
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.
