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. |