Training activity information
Details
Produce necessary documentation for a new, aseptically prepared product, following an appropriate change control process
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
- Change control
- Risk assessment
- Stability/shelf life
- Packaging
- Route of administration
- Product types
- Patient acceptability
- Product specifications
- Validations
- Design and preparation of worksheet(s)
- Design and preparation of SOPs
- Design and preparation of labels
- Staff training
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. |