QA
Quality assurance and the system as a whole
“Is the assessment genuinely cross-functional?”
Quality, validation, equipment qualification, regulatory dossier and quality agreements. The dossier question is the one most often missed.
Quality · Change control
Change control
Change control fails in two opposite directions — as a bottleneck the business routes around, or as a signature with no real assessment. Both look like a working process on paper.
In one line
Nothing should be implemented before the assessment that should have preceded it.
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 framework
The five levels, and the domains modelled so far.
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.
Change control from five GMP roles
QC
Laboratory, testing and analytical data
“Does this affect a method, specification or stability commitment?”
Analytical changes frequently carry dossier implications that are invisible on the shop floor.
Manufacturing
Production, process and the floor
“Can routine changes actually move?”
If minor changes queue behind the same committee as significant ones, the business will route around the process.
QP
Certification and batch release
“Has anything changed that affects the basis for release?”
Including changes at contract sites, which should reach you through the quality agreement.
Regulatory
Requirements, dossier and authority expectations
“Does this require a variation?”
Implementing first and filing later converts a quality process into a regulatory problem.
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.