GMP maturity models
Compliance is binary in the wrong way: a site either satisfies a requirement or does not. Capability is not binary, and most improvement conversations are really about capability. These models give that conversation a structure.
These five levels are our framework. No regulator issues or recognises them, and a level is not a statement of GMP compliance.
Five levels, applied consistently
- Level 1
Reactive
The process runs when something forces it to.
Activity is triggered by events rather than by design. Knowledge sits with individuals, records are assembled after the fact, and the same failure can occur repeatedly without anyone noticing the pattern.
- Level 2
Controlled
Procedures exist and are followed, mostly.
The process is documented and generally executed as written. Gaps appear under pressure, informal workarounds exist, and effectiveness is assumed rather than measured.
- Level 3
Systematic
The process is designed, resourced and measured.
Ownership is defined, the process is proportionate to risk, and data about how it performs is collected and reviewed. This is the level at which most inspection expectations are comfortably met.
- Level 4
Integrated
It connects to the rest of the quality system.
Outputs feed other processes: trends drive corrective action, corrective action drives change, and management review sees the whole. Decisions are risk-based and evidenced.
- Level 5
Optimized
It improves itself, and the improvement holds.
Performance is monitored against defined criteria, weaknesses are found internally before anyone external finds them, and improvements are verified for effectiveness rather than assumed.
Six domains in detail
QMS maturity
Maturity here is about whether the quality system works as a connected whole, not whether the procedures are written.
Open the modelCAPA maturity
CAPA maturity is measured by whether problems stop recurring, not by closure rate.
Open the modelData integrity maturity
Data integrity maturity is the degree to which the compliant route is also the easy route.
Open the modelValidation maturity
Validation maturity is whether the validated state is maintained, not whether the protocols were once executed.
Open the modelSupplier quality maturity
Supplier quality maturity is whether qualification is current today, not whether it was once performed.
Open the modelInspection readiness maturity
Inspection readiness maturity is whether you can demonstrate control at inspection pace without a preparation sprint.
Open the modelThe framework applies to these domains too, and they are named rather than quietly omitted: Deviation management, Change control, Training, Audit management, Quality culture, Manufacturing GMP. Detailed models will be added as they are drafted and reviewed — an unreviewed maturity model is worse than none.
A framework, not a classification
These five levels are a GMPConsultant.nl framework for structuring a conversation about capability. They are not an official regulatory classification, no authority recognises or issues them, and a maturity level is not a statement of GMP compliance.
Find your level rather than estimate it
The GMP Health Index scores seven domains and maps each to a level on this framework, in about ten minutes. It calculates in your browser and stores history on your device only.