Reflecting current regulatory expectations and good practices, the GAMP® 5 Guide and the GAMP series of Good Practice Guides help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions.
GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems
 GAMP® 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500.
This revolutionary Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.
An exciting new innovation is the CD accompanying the Guide. It provides supporting materials, including differences between GAMP® 4 and GAMP® 5, key diagrams, templates, forms, example documents, and background information. (CD is Windows compatible only.)
An electronic version of the Guide is not available at this time
GAMP® 5 - Immediate Downloads:
Item #: 5BOUNDUS
Pricing:
Member Price $250/€185
Nonmember Price $450/€375
 Order the bound version from ISPE's On-line Store
GAMP® Good Practice Guides
GAMP® Good Practice Guide: Electronic Data Archiving
Published: July 2007
Pages: 152
View Table of Contents
This Guide provides a rational and scaleable approach to electronic data archiving through the development of an archiving strategy. The implementation of such a strategy should assist organizations to achieve and maintain regulatory compliance, and to more effectively manage electronic records over the long term.
GAMP® Good Practice Guide: Testing of GxP Systems
 |
Published: December 2005
Pages: 162
Available exclusively to ISPE Members 
This is a comprehensive review of all aspects of the testing of GxP systems and is a compilation of current good practice compiled by industry experts. When planning testing activities significant thought is required to address the various risk levels involved with the system or process.
|
This Guide should be read in conjunction with the ISPE White Paper on Risk-Based Qualification for the 21st Century. This will help to ensure that one of the outcomes of the documented risk assessment is a justifiable answer to the important question "how much testing is needed for the particular system being considered?"
The Guide provides comprehensive guidance for the testing of high risk systems and gives good examples of different types of system. However, this will not be applicable to all systems and the User must decide on the level of detail and testing rigor required for their own high, medium or low risk system or process and scale all test activities accordingly. This scalability will include the scope and nature of tests planned and executed, the level of test documentation required, and the extent of the objective evidence required.
It is intended to include further examples of the risk-based scaling of such activities in a future version of this guidance document, in accordance with the concepts outlined in the above referenced white paper. Members are encouraged to provide feedback on the current version of the guidance document, indicating where such examples would be most useful and, where applicable, providing examples of such scalability.
Available at no cost to ISPE Members only
Download it Now  (PDF, 2.15 MB)
Feedback may be sent to: gamp@ispe.org.
GAMP® Good Practice Guide: Global Information Systems
 |
Published: November 2005
Pages: 96
Table of Contents
For processes that are conducted at multiple sites, there are clearly advantages to all participants using the same suite of software systems. The implementation of these multi-site computer systems can be very difficult, and for regulated systems, validation issues add an extra layer of complication.
|
Order the bound version from the ISPE On-line Store
Also available as a secure PDF* for immediate download
 from Techstreet/Thompson Scientific
* What is a secure PDF?
GAMP® Good Practice Guide: IT Infrastructure Control and Compliance
 |
Published: September 2005
Pages: 128
Table of Contents
The validated status of GxP applications that are dependent upon an underlying IT Infrastructure is compromised if that IT Infrastructure is not maintained in a demonstrable state of control and regulatory compliance. The consequences of the IT Infrastructure being out of effective control can be significant. Depending on the nature of a failure, an entire site or geographic region of operations could be brought to a standstill while the problem is resolved.
|
Order the bound version from ISPE On-line Store
Also available as a secure PDF* for immediate download
from Techstreet/Thompson Scientific
* What is a secure PDF?
GAMP® Good Practice Guide: Validation of Laboratory Computerized Systems
 |
Published: April 2005
Pages: 96
Table of Contents
The GAMP® Good Practice Guide: Validation of Laboratory Computerized Systems provides a harmonized overview of the key elements involved in the life cycle of laboratory computerized systems, from initiation to retirement. The focus of the Guide is on computerized laboratory instrumentation, data management, and analysis systems. |
Order the bound version from the ISPE On-line Store
Also available as a secure PDF* for immediate download
from Techstreet/Thompson Scientific
* What is a secure PDF?
GAMP® Good Practice Guide: Risk-Based Approach to Electronic Records & Signatures
 |
Published: February 2005
Pages: 240
Table of Contents
The appropriate management of electronic records and signatures is of current concern to both the regulated life science industry and its regulators.
|
Order the bound version from ISPE On-line Store
Also available as a secure PDF* for immediate download
from Techstreet/Thompson Scientific
* What is a secure PDF?
The GAMP® Good Practice Guide: Risk-Based Approach to Electronic Records & Signatures is used in association with ISPE training course Complying with Part 11 - Risk Management. Attendees of the training course receive a complimentary copy of this publication
GAMP® Good Practice Guide: Legacy Systems
Originally published in Pharmaceutical Engineering Vol 23, No 6
November / December 2003
Pages: 8
Available to ISPE Members only
Download it now (PDF)
GAMP® Good Practice Guide: Validation of Process Controls Systems
 |
Published: October 2003
Pages: 232
Table of Contents
Looking for measurable benefits to process control systems for both users and suppliers in relation to cost, quality, and speed-to-market? ISPE's second GAMP® Good Practice Guide: Validation of Process Control Systems (VPCS) considers how life cycle activities may be applied to a range of control, monitoring, or analytical systems designed to manage poduction processes.
|
Order the bound version from ISPE On-line Store
Also available as a secure PDF* for immediate download
from Techstreet/Thompson Scientific
* What is a secure PDF?
The GAMP® Good Practice Guide: Validation of Process Control Systems is used in association with ISPE training course Validation of Automated Equipment. Attendees of the training course receive a complimentary copy of this publication.
Validation of Process Control Systems Revision
The scope of the revision of the GAMP Good Practice Guide: Validation of Process Control Systems (VPCS) is undergoing assessment. There have been significant developments over the past couple of years in a number of areas such as the use of new technology (e.g. the use of Process Analytical Technologies and RFID), and in the validation process; particularly in terms of the adoption of risk-based approaches. It is intended that the revised version will take account of these changes. Also, since the initial publication of VPCS, a number of additional, related, GAMP Good Practice Guides have been published (e.g. A Risk-Based Approach to Compliant Electronic Records and Signatures, Testing of GxP Systems, and IT Infrastructure Control and Compliance) which the revised VPCS Guide will need to take account of.
GAMP® Good Practice Guide: Calibration Management
 |
Published: December 2001
Pages: 56
Table of Contents
The GAMP® Good Practice Guide: Calibration Management is the first in a series of GAMP® guidance on specific topics. Developed by the Calibration Management Special Interest Group of ISPE's GAMP COP in conjunction with representatives from the pharmaceutical industry and regulators, the Guide describes the principles of calibration and presents guidance in setting up a calibration management system, providing the structured approach required to establish formal criticality assessment, management, documentation, and corrective actions vital to regulatory compliance.
|
Order the bound version from the ISPE On-line Store
(Available in English and German)
Also available as a secure PDF* for immediate download
from Techstreet/Thompson Scientific (English only)
* What is a secure PDF?
The GAMP® Good Practice Guide: Calibration Management is used in association with ISPE training course Practical Approach to Calibration. Attendees of the training course receive a complimentary copy of this publication.
|
