Training activity information
Details
Audit the process for material release and make recommendations for actions including:
- Starting materials
- Packaging components
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 and good practice guidance
- Current processes and potential impact on patient safety
- Regulatory framework
- Potential impact of OOS or deviation on acceptability and patient safety
- Pharmaceutical quality system
- Documentation
- Training needs
- Physical release process
- Decision making 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. |
| # 4 |
Outcome
Apply the principles of supplier approval and quality assessment to evaluate a range of starting materials and packaging components. |
| # 6 |
Outcome
Apply the principles of quality risk management to the manufacturing process. |