Training activity information
Details
Critically evaluate clean room procedures and suggest improvements. To include:
- Transfer sanitisation
- Gowning procedures
- Aseptic processing of two product types
- Cleaning
- Release
- Aseptic verification of worksheets
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
- Regulatory requirements and National guidance
- Local SOPs
- Local policies
- Identification of good and bad points of SOP design
- Identification of good and bad points of SOP content
- Suggestions for improvement
- Change control process
- Limits of practice
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 5 |
Outcome
Develop and implement standard operating procedures (SOPs) and related documentation for a range of processes. |
| # 6 |
Outcome
Apply risk management techniques in the context of aseptic medicines. |