GMP Fundamentals
GMP is not a set of rules about paperwork. It is how a site makes sure that every batch is what the label says, every time, for a patient who has no way of checking.
A short, complete introduction to Good Manufacturing Practice, told as the life of one batch: why it has to be right, the people who make and control it, the building and equipment it is made in, how it is made and recorded, and what has to be true before a Qualified Person can release it.
Five things you will take back to site
One outcome per lesson. Each is practised in the lesson and tested at the end of it.
- Explain what GMP is forSay why a batch must be right before it is tested, how quality management, GMP and quality control fit together, and where the rules come from.
- Know your part as a person on siteKnow who is responsible for what, what training you need before you do a task, and the hygiene rules that keep you out of the product.
- Read the building and the equipmentRecognise how premises prevent mix-ups and contamination, read a status label, and check equipment is clean, calibrated and fit to use.
- Make a batch the GMP wayUse only released materials, check dispensing independently, clear the line before you start, and record every step as you do it.
- Know what release depends onUnderstand what quality control does, what the Qualified Person must be sure of, and how a product is watched after it leaves the site.
Structured so that it stays with you
Short courses are usually forgotten within a month. This one is built around the few things that are known to make material stay: hearing it as well as reading it, being asked to recall it, and meeting the same ideas again in a different form.
Narrated throughout
Every topic is narrated, so you can listen and read together, or listen alone. Hearing and reading the same material is one of the simplest ways to make it stay.
Orientation in thirty seconds
Each topic opens with the whole argument in four lines. You know where you are going before you start, which is when new material is easiest to place.
Pause and answer
Every topic stops once and asks you a question about what you have just read, with feedback either way. Recalling something is what fixes it; re-reading it is not.
Three things to remember
Each topic ends with three sentences. Not a summary of everything, but the three things you would want back in six months.
A check at the end of every lesson
Three questions per lesson, then a twenty-question final assessment. Every question is answerable from the three things to remember. Nothing is tested that was not taught.
One batch, worked through
A workshop that puts one batch record in front of you and four decisions to make in writing, before you see how an experienced reviewer would handle it.
Five lessons, in the life of one batch
Each lesson has three narrated topics and ends with a three-question knowledge check. After Lesson 5 comes the workshop, the final assessment, the job aids, and a short page on what to do in your first weeks.
| Lesson | Title | What it covers | Basis in EudraLex Volume 4 |
|---|---|---|---|
| 1 | What GMP is for | Why GMP exists, how the quality system fits together, and where the rules come from. | Chapter 1, Principle, 1.1, 1.4, 1.5, 1.8, 1.9 |
| 2 | The people | Key people and their independence, training, and hygiene and health. | Chapter 2 |
| 3 | The place and the equipment | Premises built against mix-ups and contamination, material status, and equipment you can trust. | Chapter 3; Chapter 5, 5.5 |
| 4 | Making the batch | Materials in, line clearance and in-process control, and the batch record. | Chapter 5; Chapter 4, 4.8, 4.20 |
| 5 | Releasing the batch | Quality control, QP certification, and what happens after release. | Chapter 6; Chapter 1, 1.4(xv); Annex 16; Chapters 8 and 9 |
Who this course is for
Anyone starting work on a GMP site, or anyone who wants the whole picture before specialising: production, warehouse, QC laboratory, engineering, QA and office staff who support them. It assumes no previous knowledge of GMP.
Where it sits in EU GMP
For human medicines, the principles of GMP are laid down in Commission Directive (EU) 2017/1572. EudraLex Volume 4, Part I explains them in nine chapters, from the quality system to self-inspection, with annexes for special cases. This course walks through the chapters in the order a batch meets them.
Basis
EudraLex Volume 4, Part I, Chapters 1 to 6, 8 and 9; Annex 16; Commission Directive (EU) 2017/1572
If you are about to touch your first batch record, or you want to understand why every rule on site is there, this is the course to start with.
Enrolment gives access to all five lessons, the narrated topics, the workshop, the final assessment and the printable job aids. Work through it at your own pace; your progress is saved.
