Training activity information
Details
Complete a product quality review. Identify suggestions to improve practice and feedback the outcome to the wider team.
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
- Pharmaceutical quality system
- Statistical methods
- Communication with stakeholders
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 |
Outcome
Describe the working practices of pharmaceutical production. |
| # 2 |
Outcome
Apply the principles of good manufacturing practice (GMP) to the development of new products. |
| # 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. |
| # 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. |