GAMP 5
Ability to apply GAMP 5 practices and professional judgment to deliver reliable outcomes in quality & regulatory contexts.
What each level means
The P1–P5 scale is shared across every skill, but what each level means changes with the skill. This is what it looks like in practice.
P1
Describes the process, controls, stakeholders and basic decisions involved in GAMP 5.
P2
Executes standard GAMP 5 activities accurately within established controls and escalates exceptions.
P3
Owns complex GAMP 5 cases/processes, improves controls and coaches colleagues.
P4
Sets cross-team standards and governance for GAMP 5, integrating risk, metrics and stakeholder needs.
P5
Defines enterprise strategy or external practice for GAMP 5 and develops other experts.
Source: PROCOMER FTZ employer benchmark