Beschreibung
e-Learning: EU GMP Guideline Chapter 5 | Production
GMP-compliant production is an important element!
The GMP requirements for production can be found in Chapter 5 of the EU GMP Guide. The quality of the product is paramount. Production operations must be carried out according to clearly defined procedures. The procedures must comply with the principles of GMP in order to result in products that have the required quality and that comply with the manufacturing authorization and the respective approval documents. What are the rules and requirements in detail?
Outline
In this module, you will learn about important GMP requirements for production and how to implement them in practice.
You will refresh your GMP knowledge from training courses you have already completed.
Online short assessment and certificate
At the end of the module you may complete a short assessment. If you reach a passing score of at least 80%, you will receive your certificate via email.
Module language: English
Contents
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- General requirements
- Prevention of cross-contamination
- Validation
- Starting materials
- Manufacturing processes
- Packaging materials
- Packaging operations
- Finished products
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Audience
- Employees who work in production
- Employees of quality units
- Employees of external companies working for GMP areas
- Employees of suppliers of raw materials and packaging materials
Features
- Interactive exercises
- Self-paced learning right at your workplace
- Glossary of helpful terms and explanations
- Suitable as initial training, but also as refresher training or follow-up training
- With certificate
Industries
- Pharmaceuticals
- Active Ingredients
- Contract manufacturers
- Sales
- Logistics
- Suppliers
Individual solution
This e-learning module can also be customized by our learning engineer team for your company with your internal information (e.g. contact details), content (e.g. organizational charts, schedules, forms, leaflets) and your corporate identity. Feel free to contact us!
License
Single license with a 365 day term.
e-Learning: EU GMP Guideline Chapter 5 | Production