QA
Quality assurance and the system as a whole
“Does the validated position match the site as it exists today?”
Reconcile the validation master plan against the floor. A plan that has drifted makes every document downstream of it unreliable.
Quality · Validation
Validation
Validation is a state to be maintained rather than a project to be completed, and its decay is silent until something forces the question.
In one line
Maturity is whether the validated state is still true, not whether protocols were once executed.
Start hereEach step links to the next rather than dead-ending.
From understanding to action
01 · Understand
Reference article
The requirement, the failure modes and the primary sources.
02 · AssessGMP Health Index
Score this domain and see where it sits against the others.
03 · PositionMaturity model
What each level looks like, and what moves you up one.
04 · QuantifyCost of Inaction Model
Turn the current position into an annual carrying cost.
One GMP problem. Multiple perspectives.Roles that genuinely see this differently — not the same text with the job title changed.
Validation from five GMP roles
QC
Laboratory, testing and analytical data
“Are analytical methods validated for their current use?”
Method lifecycle documentation and continued suitability, including where the method has been transferred or the matrix changed.
Manufacturing
Production, process and the floor
“Are we running the process that was actually validated?”
Routine adjustments nobody documented mean the validated process and the real one have diverged.
QP
Certification and batch release
“Is the validation status adequate for certification?”
Qualification and validation status form part of the assurance the certification decision rests on.
Regulatory
Requirements, dossier and authority expectations
“What does Annex 15 require here?”
The number of process validation batches should be justified rather than assumed; three is a convention, not a requirement.
Related
Reading, services and tools
Where we do the work
People and training
Next step
Score it rather than estimate it
The GMP Health Index scores seven quality-system domains and maps each to a maturity level. It calculates in your browser and keeps history on your device only.