GMP Professional Certificate

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About Course

Work confidently in a GMP environment: understand the rules, keep compliant records, handle deviations and CAPA, and be ready for any audit or inspection.

Who it’s for

New starters and career-changers joining pharmaceutical manufacturing, QA, QC or warehouse teams, and professionals who need a solid, practical grounding in Good Manufacturing Practice.

What you’ll be able to do

  • Explain how EU, UK and US GMP rules fit together and what inspectors look for
  • Describe a pharmaceutical quality system using ICH Q9 and Q10
  • Keep records that meet good documentation practice and ALCOA+ data integrity
  • Raise, investigate and close deviations using root cause analysis and CAPA
  • Explain qualification, validation and change control
  • Apply contamination control and hygiene principles, including EU GMP Annex 1
  • Prepare for audits, inspections and supplier oversight

What’s included

  • 8 in-depth modules, each with a structured lesson
  • 8 module quizzes to check your understanding
  • Worked examples and a practical exercise in every module
  • About 40 hours of study, at your own pace
  • Lifetime access, on any device
  • Certificate of completion

How you study

Each module combines a structured lesson with a worked example, a practical exercise and key takeaways, followed by a short quiz. You need 70% to pass each quiz and can retake it as often as you like. Complete every module to finish the course.

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What Will You Learn?

  • Explain how EU, UK and US GMP rules fit together and what inspectors look for
  • Describe a pharmaceutical quality system using ICH Q9 and Q10
  • Keep records that meet good documentation practice and ALCOA+ data integrity
  • Raise, investigate and close deviations using root cause analysis and CAPA
  • Explain qualification, validation and change control
  • Apply contamination control and hygiene principles, including EU GMP Annex 1
  • Prepare for audits, inspections and supplier oversight

Course Content

GMP foundations and the rules
Why GMP exists and how EU, UK and US rules fit together

  • GMP foundations and the rules
  • Module check: GMP foundations and the rules

The pharmaceutical quality system
ICH Q10, quality risk management and the Qualified Person

Documentation and data integrity
Good documentation practice, ALCOA+ and computerised systems

Deviations, investigations and CAPA
Handling things that go wrong and stopping them happening again

Premises, equipment and validation
Qualification, calibration, cleaning and process validation

Contamination control and hygiene
Personnel hygiene, cleanrooms and EU GMP Annex 1

Production, quality control and release
In-process controls, OOS results, complaints and recalls

Audits, inspections and suppliers
Self-inspection, supplier oversight and inspection readiness