Training activity information
Details
Write a test specification for:
- A starting material
- On receipt
- Retest
- A finished product
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
Considerations are suggestions about what may be useful for the trainee to think about while undertaking a training activity. They should not be considered as a mandatory checklist. Trainees should not be expected to demonstrate or provide evidence for each of the considerations listed.
- Customer requirements
- Regulatory requirements
- Supplier status
- Testing requirements
- Dosage form
- Route of administration
- Appropriate limits
- Skip-lot testing
- Chemical testing
- Microbiological testing
- Sample handling and COSHH
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 4 |
Outcome
Write specifications for routine quality control and stability assessment based on relevant standards and guidance. |
| # 7 |
Outcome
Describe the requirements of data integrity related to quality control systems. |