GAMP 5 - Good Automated Manufacturing Practice
Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 6.2.6: Planning

What does 6.2.6 require?

Planning covers every aspect of developing the system, including the work that shows that it complies and is fit for the use intended. It sets out who is responsible, what will be delivered and which procedures apply, and determines how supplier work and documents will be reused so that effort is not needlessly repeated, as the supplier may produce deliverables itself or take a direct part in the activities. The plan draws on the initial risk assessment, the categorisation and the supplier assessment, and Appendix M1 gives the detail.

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.

  • 5.1.1 5.1.1 Software development plan

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 6: Regulated company activities (governance and system-specific activities) – 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.