Training activity information
Details
Critically appraise a plan for the development of a new product including:
- Formulation
- Packaging and labelling
- Manufacturing methods
- Shelf life
- Product specification
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
- Communication with key stakeholders
- Regulatory standards
- Pharmacopeial requirements
- Product use, including administration route and patient factors
- End user needs
- Sourcing starting material and packaging components
- Validation
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 2 |
Outcome
Apply the principles of good manufacturing practice (GMP) to the development of new products. |
| # 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. |