GMP Bulk - Basic GMP training for API production |
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| Language versions |
Dutch, English, German, French, Spanish, Swedish, Danish and Chinese (Mandarin).
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| Target |
Learning about GMP concerning the production of active pharmaceutical ingredients and intermediates according to ICH Q7A.
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| Quote |
'Everyone is obliged to follow this course within 6 months after entrance into the company.'
Susanne Le Claire-Moser, Novartis Pharma (Basel
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| Subjects |
The programme consists of 3 modules:
Module 1: Introduction of GMP
- What is the meaning of GMP and Q7A?
- Cleaning areas and equipment
- Purity of raw materials
- Identification of production components
- Order and Neatness
- Working Attentively
- Maintenance
- Validation
- Documentation
- Quality control
- Processing
- Test
Module 2: Backgrounds of GMP
- Documentation
- Following Procedures & Instructions
- Taking Samples
- Quality Audits
- Qualified Personnel
- Test
Module 3: GMP-practical cases
- Problems during validation
- Mistakes during cleaning
- Wrong formulation
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| Didactics |
The modules increase in difficulty.
In each module 'right' and 'wrong' is shown on the basis of practical video fragments.
In Module 1 GMP is explained casually with the principle: "Need to know".
Module 2 partly contains a repetition of the subject matter of Module 1. After that this module supplies more details about sudden aspects. The emphasis lies on 'instruction'.
Module 3 contains three filmed reports of GMP incidents, which have happened recently. During these reports the trainee has to give his/her opinion about the incidents and the decisions that have been taken.
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| Test |
Yes.
Module 1 and 2: each a test; Module 3 is a test itself.
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| Targetgroup |
Operators and QC (Quality Control) employees in companies that work according to Q7A.
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| Initiative |
Pharmaceutical industry, especially producers of active pharmaceutical ingredients, intermediates and semimanufactured product.
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| Media |
Internet
Video (80 minutes)
Photo
Audio
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| Route |
Yes.
Each target group follows one specific route.
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| Documentation |
Yes.
The registered course data is presented in detail. Several statistics about the use and scores can be displayed. A question analysis is also available. A trainee certificate with company logo can be printed.
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| Editor |
Yes.
With the editor texts can be adapted online to meet specific company circumstances.
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| Study time |
3 to 4 hours (advice: each module separately).
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