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GDP In development

Good Distribution Practice Essentials

A medicine can leave the factory in perfect condition and still reach the patient warm, damaged, diverted or swapped for a fake. Everything that stops that happening takes place in the warehouses, vans and offices in between.

A short, complete course on good distribution practice as the EU GDP Guidelines expect it to work: who answers for the supply chain, buying only from lawful sources and receiving goods with care, storing them in the conditions on the label, selling only to entitled customers and moving stock safely, and handling returns, suspect packs and recalls so that the next patient is protected.

Duration
2 to 3 hours, self-paced
Level
Foundation
Lessons
5 lessons

This course is in development

Good Distribution Practice Essentials is not open for enrolment yet. Join the waitlist and we will email you when it opens. Waitlist members receive the launch price, an early look at the curriculum and a chance to tell us which situations from their own site the course should cover.

Notify me when it opens

What the course teaches and assesses

  • Know who answers for what: Say which activities count as wholesale distribution, what the quality system has to deliver, and which decisions stay with the responsible person however the work is shared out.
  • Buy and receive safely: Check that a supplier may lawfully sell to you, weigh the warning signs in an offer, and stop wrong, damaged or suspect packs at goods-in.
  • Store to the label: Keep stock segregated by status, show through mapping, monitoring and alarms that storage conditions were met, and rotate stock by expiry.
  • Sell and move with control: Supply only entitled customers, write records that let any pack be traced, and keep products within their labelled conditions in your own vans and with a courier.
  • Put it right: Handle complaints and returns on evidence, report suspected falsified packs at once, test the recall system, and use self-inspection to find gaps first.

Lessons

  1. 1The chain and who answers for it
  2. 2Buying and receiving
  3. 3Storing
  4. 4Selling and moving
  5. 5When things come back or go wrong
  6. Scored final exam and dated certificate

What this course does and does not do

Covered

  • Know who answers for what
  • Store to the label
  • Put it right

Not covered

  • Responsible Person qualification or appointment
  • Your wholesale distribution authorisation application
  • Your own site's SOPs, mapping studies or transport validation

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

  • Warehouse, logistics and transport staff
  • Customer service and quality staff at distributors
  • Newly appointed responsible persons
For managers

Rolling good distribution practice essentials 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

  • EU GDP Guidelines (2013/C 343/01), Introduction, Chapters 1 to 10 and Glossary
  • ICH Q9(R1), 3

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