Training activity information
Details
Perform the manufacture of at least two products of differing dosage form, including one non-sterile product
Type
Entrustable training activity (ETA)
Evidence requirements
Evidence the activity has been undertaken by the trainee repeatedly, consistently, and effectively over time, in a range of situations. This may include occasions where the trainee has not successfully achieved the outcome of the activity themselves. For example, because it was not appropriate to undertake the task in the circumstances or the trainees recognised their own limitations and sought help or advice to ensure the activity reached an appropriate conclusion.
Reflection at multiple timepoints on the trainee learning journey for this activity.
Considerations
- Critical controls and the potential impact of any failures on patient safety
- Selection of starting materials
- Preparation of containers and closures
- Weighing
- Mixing
- Heating
- Filling
- Sealing
- Inspection
- Sampling (including in-process)
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. |
| # 5 |
Outcome
Perform activities to support safe storage and distribution of medicinal products applying the principles of Good Distribution Practice (GDP). |
| # 6 |
Outcome
Apply the principles of quality risk management to the manufacturing process. |