QA
Quality assurance and the system as a whole
“Is qualification current, and were questionnaires actually assessed?”
A returned questionnaire is evidence only once somebody has evaluated it and recorded a conclusion.
Quality · Supplier quality
Supplier quality
Outsourcing an activity does not outsource the accountability, which makes supplier qualification a continuity question as much as a compliance one.
In one line
The measure worth tracking is how many suppliers are qualified today, against current agreements.
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 · If it is urgentCrisis guidance
First actions, evidence to preserve and what not to do.
One GMP problem. Multiple perspectives.Roles that genuinely see this differently — not the same text with the job title changed.
Supplier quality from five GMP roles
QC
Laboratory, testing and analytical data
“Does incoming testing reflect the risk this supplier carries?”
Reduced testing regimes depend on a qualification position that is still true.
Manufacturing
Production, process and the floor
“What happens to supply if this supplier stops?”
Their compliance position is an operational dependency, not a procurement detail.
QP
Certification and batch release
“What is the documented basis for relying on this site?”
Annex 16 expects audits, quality agreements and defined information flows to underpin reliance.
Regulatory
Requirements, dossier and authority expectations
“Are change-notification obligations being met?”
An unnotified supplier change discovered during an investigation is a recurring and avoidable finding.
Related
Reading, services and tools
Knowledge base
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.