Competency information


Write a product specification that addresses user requirements.


  • 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.