GAMP 5 - Good Automated Manufacturing Practice
Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 4.2.5.2: 4.2.5.2 Project Change and Configuration Management

During the project, every controlled item that has undergone review, approval or test is placed under configuration management and change management from its first formal approval, at a level of formality that grows as the project advances, so that specifications, code, configuration, test records and other deliverables are not changed without assessment and authorization. The project change process is simpler than operational change control, its point of transfer to operational change management is defined before handover, and configuration management establishes the baseline that operational configuration management inherits, as detailed in Appendix M8.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • 8.2.1 8.2.1 Approve change requests

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice

Query this from an agent

The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.