GMP Explained: What GMP Really Means in Daily Practice
Introduction
GMP is often reduced to documentation, SOPs, and inspection readiness.
Many professionals work for years in GMP environments and still struggle to explain what GMP actually means.
In daily practice, GMP is neither abstract nor theoretical.
It is visible — every day — in decisions, responsibilities, and how systems are used under real conditions.
This article is part of my “GMP Explained” series, created to clarify what GMP really is — and what it is not.
What GMP is not
GMP is frequently misunderstood. It is not:
a documentation exercise
a checklist to satisfy auditors
a responsibility owned solely by Quality Assurance
something that only matters during inspections
These assumptions often create unnecessary complexity and frustration.
What GMP actually is
GMP is the consistent ability of an organization to produce quality products under controlled conditions — every single day.
It is reflected in:
how processes are designed
how responsibilities are defined
how deviations are handled
how decisions are made under pressure
Documentation supports GMP, but it does not define it.
When GMP really begins
GMP does not start at an abstract regulatory line.
It begins the moment:
material is intended for medical use
batch identity is created
release decisions become necessary
Typical GMP entry points in practice include:
repackaging for medical supply
processing steps such as milling, sieving, or extraction
batch labelling
transfer into a medical release and distribution system
From this point onward, GMP requires formalized processes, qualified analyses, deviation handling, and documented batch release.
Why audits reveal reality
Audits are not about finding mistakes.
They show whether a system actually works.
They reveal:
if processes are understood
if documentation reflects reality
if responsibilities are clear and lived
GMP does not fail on paper.
It fails — or succeeds — in daily practice.
A sentence I hear surprisingly often
One of the most meaningful compliments I have received is:
“You are the first person who made me understand what GMP actually means.”
This usually happens when GMP is explained through real processes and decisions — not through regulations alone.
Experience from both sides of the audit table makes this difference visible.
GMP in daily operations
In practice, GMP is tested when:
deviations occur
time pressure increases
systems are stretched by growth
teams must explain why things are done a certain way
Well-designed systems support people in these moments.
Overengineered systems often fail silently.
Closing perspective
GMP rarely fails because people do not care.
It fails when systems are unclear, overloaded, or misunderstood.
This perspective shapes how I support organizations as an external GMP consultant and auditor.
