3.4 GAMP

The GAMP guide is produced by a number of pharmaceutical companies for suppliers and users of computer systems and automated equipment for the pharmaceutical development industry. It is for companies that have to comply with requirements for validation of systems and equipment established by the U.S. Food and Drug Administration (FDA), although the FDA does not approve the guide as such. The guide discusses many other process areas besides configuration management.

As can be seen in the following paragraph, the guide includes appendices with examples of how to handle various process areas. The guide is straightforward and informative and provides ideas on how to approach configuration management on a smaller, more restrictive scale. The guide is also available on CD.

Description from the Guide

Configuration Management ensures that the automated system remains in a controlled state at all times during the system life-cycle. This will secure quality and consistency in the hardware, software and documentation of the automated system being developed . . . .

The supplier should establish and maintain a formal system for configuration management including document control and change control. In the absence of a configuration management system, that defined in Appendix CC should be followed. The point at which configuration management is applied should be stated in the Quality and Project Plan.

Configuration management includes the disciplines of change control and document management. These may be treated as separate disciplines, for which there are separate procedures but must be incorporated in the overall configuration management plan to ensure traceability.

Document Control is a formal system for the production, review, approval and issue of documents relating to the contract. In the absence of such a system, that defined in Appendix E should be followed . . . .

Change Control is a formal system for the control of all system changes. This procedure should apply to documentation, hardware, software, and network configuration and should cover the following:

• Documenting changes from one version to the next

• Approving such changes before they are implemented

• Identifying all items affected by the change

• Checking and approving that changes made have been completed correctly

During development any changes to contractual documentation should be agreed with the user . In the absence of a change control system, that defined in Appendix F should be followed . . . .