Self-Inspection and Internal Audit in GMP Environments
EU GMP Chapter 9 requires self-inspections. It does not tell you how to run one. This course takes you from the annual programme through the audit itself to a corrective action you can prove worked.
- Lessons
- 11
- Topics
- 53
- Narration
- 4 hours
- Access
- 12 months
- Narrated from beginning to end. Every topic carries a spoken track, so the course works at a desk, in a car, or during a shift change.
- Written against the clause. Regulatory statements are traced to EU GMP, ICH or the relevant guideline, with the clause number in the reference section.
- Checked as you go. A knowledge check after every lesson, a final assessment across the course, and a dated certificate in your name on passing.
Why this course
Every site does self-inspections. Rather fewer get anything back from them.
Chapter 9 of the EU GMP Guide is four paragraphs long. It requires self-inspections to be conducted according to a pre-arranged programme, by trained persons not involved in the activities being examined, with the observations recorded and corrective action proposed. Everything else, the frequency, the depth, the classification of what you find and the standard of proof for closing it, is left to you. That is where self-inspection programmes quietly stop working.
The common failures are recognisable. A flat annual cycle that audits a sterile filling suite and a stationery store at the same frequency. Findings written as “some batch records were incomplete”, which nobody can act on. Corrective actions closed with retraining and the note “no further findings”, which is an observation made after the fact rather than a test the action passed. And the one that matters most, the repeat finding, which says plainly that the last corrective action did not work.
The course is European throughout. EU GMP Chapter 9 for the requirement, Chapter 1 for where self-inspection sits in the quality system, ICH Q9 (R1) for making the frequency proportionate to risk, ICH Q10 for feeding findings into management review, and the PIC/S Guide for how inspectors read your programme. Nothing is drawn from outside the European system.
Narrated from beginning to end. Every topic carries a spoken track, so the course can be taken at a desk, in a car, or on a phone during a shift change. Very little online GMP training is narrated, and reading screen after screen of text is how good training quietly gets abandoned half way through.
Outcomes
What you will be able to do
Audience
Who this is for
Written for the people who run, host or govern self-inspections: QA managers and QA associates, internal auditors and lead auditors, production and QC supervisors who are audited and want to know what good looks like, Qualified Persons, and site management who receive the results.
It also suits a site that has an audit programme on paper and knows it is not earning its keep. Most of what is wrong with a self-inspection programme is visible in its last four reports, and this course tells you what to look for in them.
Prerequisite. None. A basic familiarity with working in a GMP environment is enough. The first lesson builds up from what a self-inspection is and how it differs from a customer audit and from a regulatory inspection.
Curriculum
The course, lesson by lesson
What is included
What you get with enrolment
Thirty three topics across six teaching lessons and a reference section, narrated throughout.
That is the whole course. If it matches the standard you want on site, joining the founding list holds this price for you until it opens.
Evidence of training
Your certificate
On passing, a certificate is issued in your name and dated, carrying the course code TC-GMP-SI-07. It records that the course addresses the requirements of EU GMP Chapter 9 and Chapter 1, ICH Q10 and ICH Q9 (R1), and the PIC/S Guide to GMP, as they apply to the planning, conduct and follow-up of self-inspection.
It is the record a training file needs, and it names what was actually taught rather than a generic title.
What it looks like
Truex Consultancy
Certificate of Completion
This is to certify that
John Doe
has successfully completed the course
Self-Inspection and Internal Audit in GMP Environments
Date of completion: March 14, 2026
Authorised by Truex Consultancy | Training standard EudraLex Volume 4 GMP |
Good Manufacturing Practice Training · Truex Consultancy
A sample. John Doe is not a real learner, and the date is illustrative. Your certificate carries your own name, the date you finished, and this course title.
Author
Who wrote it
More than ten years in pharmaceutical quality assurance, gained on the floor rather than in a lecture theatre, including quality roles at Centrafarm and Lonza. Qualified Responsible Person, Lean Six Sigma certified, with a Farmakunde background.
Through Truex Consultancy he works as an interim GMP and GDP compliance consultant to pharmaceutical, biotechnology and medical device companies across Europe, in Dutch and English. Self-inspection is the one part of the quality system that can tell a site the truth about itself, and the part most often run as a formality.
Questions
Questions people ask
Price and access
What it costs
How that compares
Published prices for comparable European GMP training, checked in August 2026. The formats are not identical and it is worth saying so: a live session has something recorded training cannot, which is a tutor in the room. What it does not have is a second chance. It runs once, on a date somebody else chose, and when it ends there is nothing to go back to.
The retention design
Price is the easy comparison. The one that matters is whether any of it is still there in six months, when the inspector is in the building. Four things in this course are built for that, and a single live session cannot do any of them once the afternoon is over.
That is not a claim about how much more anyone remembers. It is simply what the course does: it tests you, it lets you space it out, it stays available for a year, and it gives you the material twice over. Training that is taken once and never returned to is the most expensive kind, whatever it cost.
Training several people? Get in touch for team pricing. Most sites train a whole quality unit rather than one person, and the material is designed to be used that way.
Audit yourself before somebody else does.
Enrol yourself or your team, and make the programme worth the time it already takes.
Keep today’s price, and hear from us once.
The catalogue is in final production. Joining the founding list locks this course at €179 for you, whenever it opens, and sends you one email on the day it does.
No date to miss, and no sequence of emails. Your price is held either way.
