Training activity information
Details
Devise or critically appraise a troubleshooting matrix for the process of generating water for injection
Suggest improvements where appropriate
Type
Developmental training activity (DTA)
Evidence requirements
Evidence the activity has been undertaken by the trainee​.
Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.
An action plan to implement learning and/or to address skills or knowledge gaps identified.
Considerations
- Water plan design
- Control measures
- Impact on patient safety and product quality
- Purification process
- Sampling point locations
- In-line monitoring
- Routine PPM
- Routine sampling and testing
- Bulk storage and distribution
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 |
Outcome
Describe the working practices of pharmaceutical production. |
| # 3 |
Outcome
Perform a range of manufacturing activities, using specialist equipment, in accordance with requirements for GMP and pharmaceutical quality management systems. |
| # 6 |
Outcome
Apply the principles of quality risk management to the manufacturing process. |