Articles
The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems GAMP 4
October 30, 2003
GAMP 4 is the most widely used, internationally accepted, guideline for validation of computer systems. Developed by ISPE's GAMP Forum technical subcommittee, GAMP 4 was most recently referenced in the FDA's Final Guidance on 21 CFR Part 11, Electronic Records; Electronic Signatures. In addition, it was referenced in the PIC/S Guidance on "Good Practices for Computerized Systems in Regulated GXP Environments" and is being used as a training and reference resource for regulators worldwide.GAMP 4 is a significant advance on previous versions of this globally accepted guidance. The document has been considerably enhanced, restructured, and refined to reflect current regulatory expectations and good practice.
More than 70 healthcare professionals, from the Americas and Europe, participated in the production of GAMP 4 by contributing to groups producing new and revising existing material. GAMP 4 is intended for suppliers and users in pharmaceutical manufacturing and related healthcare industries such as biotechnology and medical device. The Guide draws together key principles and practices and describes how they can be applied to determine the extent and scope of validation for different types of automated systems.
GAMP 4 helps organizations develop:
· validated and compliant automated systems using the concept of prospective validation following a life cycle model
· procedures to ensure the automated system remains in a validated state once it is validated and in operation
· Benefits of Using GAMP 4
· cost benefits-by aiding the production of systems that are fit for purpose, meet user and business requirements, and have acceptable operation and maintenance costs
· better visibility of projects to ensure delivery on time, on budget, and to agreed quality standards
· increased understanding of the subject and introduction of a common language and terminology
· reductions in the cost and time taken to achieve compliant systems
· improved compliance with regulatory expectation by defining a common and comprehensive life cycle model
· clarification of the division of responsibility between user and supplier
Now Available in French and German (Bound version only)
Now Available on CD-ROM (English Only)
GAMP 4 now is available on CD-ROM and includes all the benefits of GAMP 4 in a portable and easily searchable electronic format. GAMP 4 electronic is an excellent reference tool that has been designed to be easy to use on Windows® 98, 2000, ME, or XP without the need to install files onto your system.
The CD-ROM provides additional materials including template forms and example procedures from the appendices of GAMP 4 and a document explaining the mapping of GAMP 3 to GAMP 4 in MS WordTM and AdobeTM PDF formats. The main GAMP 4 document is designed to be read electronically and cannot be printed or copied.
**Site and Worldwide Licenses
The Network Version - Site License includes 10 bound copies of GAMP 4, 10 Individual User CD-ROMs, and two Network CD-ROMs. The Worldwide License includes 50 bound copies of GAMP 4, 50 Individual User CD-ROMs, two Network CD-ROMs with option to obtain more at no cost based on number of major servers, two days of In-House Training, and special discount for purchase of additional bound copies. Please contact ISPE for complete details on Worldwide Licenses. Travel and accommodation costs for the In-House Trainer are not included and will be an additional fee.
System Requirements for GAMP 4 Electronic
Windows® 98, 2000, ME, or XP
Intel Pentium II® / AMD Athlon™ 400 MHz CPU or faster processor
64MB RAM (128MB RAM for Windows® 2000/256MB RAM for Windows XP)
16x CD ROM drive using 32-bit Windows® CD-ROM driver
A Windows® compatible mouse is required to for scrolling and to use buttons and footnotes. The Menu Bar options may be accessed using the arrows keys on a Windows® compatible keyboard.
GAMP 4 electronic has been designed for a screen area display setting of 800 x 600 pixels and is a fixed window size that is not full screen.
