e-Learning: Documentation




Documentation requirements according to Chapter 4 of the EU GMP Guideline

Which documentation requirements can be found in Chapter 4 of the EU GMP Guideline? This PTS e-Learning module increases your proficiency in the field of GMP documentation


e-Learning: Documentation


GMP-compliant documentation is an important element!

The GMP requirements for documentation can be found in Chapter 4 of the EU GMP Guideline. The documentation consists of standard and recording documents and can be paper-based or electronic. What rules and guidelines are there and how can they be implemented in practice?




  • What is part of the GMP documentation?
  • How can documentation be done?
  • Which documents are GMP-relevant?
  • Purpose of the documentation
  • What is Compliance?
  • Specification documents
  • Recording documents
  • The meaning of the signature
  • What are raw data?
  • GMP-compliant documentation systems
  • Archiving
  • Final assessment (optional)


  • In this module, you will learn about important GMP documentation requirements and how to implement them in practice.
  • You will refresh your GMP knowledge from previously completed training courses.
  • You will complete a final assessment to obtain a certificate.

Target groups

  • Employees of quality units
  • Employees who create, manage or apply SOPs
  • Employees of external companies working in GMP areas
  • Suitable as initial training, refresher training or retraining

Special features

  • Interactive exercises
  • Learn at your own pace
  • From your workplace
  • Glossary with helpful terms and explanations
  • With certificate

Industry sectors

  • Medicinal products
  • Active ingredients
  • Contract manufacturers
  • Contract laboratories
  • Sales & Distribution
  • Logistics
  • Suppliers


e-Learning: Documentation


Anna Diehl, PTS Training Service

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