Competency information
Details
Perform product compatibility and stability testing against the specification.
Considerations
- Regulatory aspects. Different licence types.
- Major dosage forms.
- Interaction between excipients and active pharmaceutical ingredients (API).
- The function of the excipient.
- Accelerated stability testing.
- Factors around absorption of active pharmaceutical ingredients and ways of addressing the challenges.
- Clinical trials (overview).
- Governance issues ethics.
- Patient use.
- Quality assurance.
- Documentation and records:
- quality assurance/control documentation
- manufacturing documentation.
- Document design.
- Manufacturing authorisation application.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 | Outcome Perform a pharmaceutical development and formulation exercise to meet the clinical needs of a particular patient product. |