Pharmaceutical Water - Guidelines and Practice
Knowledge about pharmaceutical water systems tends to take a back seat within pharmaceutical companies. This interactive training has been set up with the aim of giving participants a solid basic knowledge of this subject.
- 1 day
- Course fee
- € 795 (excl. VAT)
In this course the new guidelines of the European Pharmacopoeia as well as the requirements of the FDA are covered. Topics include:
- Regulations and guidelines (Europe, United States)
- Differences in water quality within a pharmaceutical production environment
- Differences between RO water, PW and WFI, (Reversed Osmosis, Purified Water and Water for Injection)
- Monitoring and testing of the water flow
- Trend analysis,
- Test plans in the form of a workshop
- V-model for the qualification of a new water system
The new guidelines offer the possibility to make and use not only warm WFI but also cold WFI in Europe. During the training this matter will be discussed in further detail. In addition, the distillation process is explained.
Another interesting part of the training is that we will be looking at a WFI production system with explanation of the various components, allowing you to see from closeby how it all works. In the course of this interactive training participants are actively involved in the various subjects. There is plenty of opportunity to ask questions from the perspective of your own professional role or work situation.
- Acquire basic knowledge of the unit operations for water systems
- Be aware of the requirements from Europe and the United States regarding WFI systems
- Gain insight into how to implement cold WFI
- Gain knowledge of qualification processes and monitoring of a WFI system
- Understand the different steps in the preparation of WFI
- Know the difference between WFI in bulk and in bottles
- QA staff and QA auditors who want to know more about the background of water systems
- Technical staff responsible for water systems
- Consultants who want to gain a basic knowledge of water systems
Guidelines for pharmaceutical water
• What are the requirements for the quality of the water used for various types of pharmaceutical products?
Qualification when purchasing new water systems or adaptations to the water system
• Design qualification
• Test methods and acceptance criteria
Workshop "WFI: make your own sampling scheme".
Preparation of a monitoring plan based on a technical drawing of a water system.
• Regulatory changes
• Single Effect Still (SE)
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