Training activity information
Details
Audit the process for product release and make recommendations for actions
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. |
| # 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. |