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GMP Training Academy
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GMPOpen for enrolment

GMP Fundamentals

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.

Duration
About 1 hour of core reading, self-paced
Level
Foundation
Lessons
5 lessons
Enrol: €179 + VAT See a sample lessonDo I really need this course?

What the course teaches and assesses

  • Say 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 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
  • Recognise how premises prevent mix-ups and contamination, read a status label, and check equipment is clean, calibrated and fit to use
  • Use only released materials, check dispensing independently, clear the line before you start, and record every step as you do it
  • Understand what quality control does, what the Qualified Person must be sure of, and how a product is watched after it leaves the site

Lessons

  1. 1What GMP is for: why it exists, the quality system, where the rules come from
  2. 2The people: who is responsible, training, hygiene and health
  3. 3The place and the equipment: premises, storage and status, equipment
  4. 4Making the batch: materials in, line clearance and in-process control, the batch record
  5. 5Releasing the batch: quality control, certification by the Qualified Person, after release
  6. Scored final exam and dated certificate

What this course does and does not do

Covered

  • The life of one batch, in EU GMP order: quality system, people, premises and equipment, making the batch, release
  • Narrated topics, a pause-and-answer question in every topic, a knowledge check after each lesson and a final assessment
  • A worked case on one batch record, and four printable job aids

Not covered

  • Role-specific training required by your site's training matrix
  • Outsourced activities (Chapter 7), sterile manufacturing and Annex 1, and annexes other than Annex 16
  • Any substitute for induction on your own procedures

This course is professional training. It does not replace your site’s procedures, and it is not regulatory or legal advice on a specific event.

Who it is for

  • Anyone starting work on a GMP site
  • Production, warehouse, QC laboratory, engineering and QA
  • Office staff who support them, and anyone who wants the whole picture before specialising
Before you decide

Do you really need this course?

10 questions from real inspection findings. Three minutes. No sign-up.

Not started

Ten questions about the basics that inspectors still find missing. If you are new to GMP, expect several yeses. That is what the course is for. Nobody sees your answers.

For managers

Rolling gmp fundamentals out to a team?

The Site Readiness Programme adds a team heatmap from the self-assessment, a live session on the weakest questions, and records named by employee ID. Quote within two working days.

  • Seats for the whole team, priced per learner from 5 learners
  • Anonymised team heatmap: which questions your people fail, by chapter
  • 90-minute live session built on the team's weakest questions
See the programme

Regulations referenced

  • EudraLex Volume 4, Part I, Chapters 1 to 6, 8 and 9
  • EU GMP Annex 16
  • Commission Directive (EU) 2017/1572

Continue the path

MRPractitioner
Open for enrolment2 to 3 hours, listening or reading plus checks, self-paced

Management Review Essentials

Management review as EU GMP and ICH Q10 expect it to work: what it is for, the inputs it needs, how to run it so it decides things, the outputs it must produce, and how to close the loop so the quality system actually improves.

5 lessons · knowledge checks · scored final exam

€179excl. VATView course
GDocPFoundation
Open for enrolmentAbout 2 hours, self-paced

Documentation and Data Integrity Essentials

The life of one GMP record as EU GMP expects it to run: made at the time under your own name, corrected so the original can still be read, reviewed in the system rather than on the printout, and kept readable for as long as it has to last.

5 lessons · knowledge checks · scored final exam

€179excl. VATView course