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 4.3.3: 4.3.3 Operation: Incident and Problem Management and CAPA

Unplanned interruptions and reductions in service quality are reported, categorized, prioritized, investigated and resolved as incidents, the root causes of one or more incidents are addressed through problem management, and incidents on GxP configuration items are assessed for their effect on patients, product quality and the integrity of data, with the quality unit informed and, where warranted, a deviation raised and a corrective and preventive action process applied that investigates impact, plans corrective action, analyses root cause, defines preventive action, monitors completion, checks effectiveness and trends, as detailed in Appendices O4 and O5.

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.

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.