Competency information


Assist in performing an internal or external audit of suppliers and/or contract manufacturers.


  • Literature searching.
  • Purpose of pharmacovigilance audit.
  • Medicines and Healthcare products Regulatory Agency (MHRA) Good Pharmacovigilance Practice.
  • Audit cycle.
  • National guidelines for pharmaceutical quality audits.
  • Purpose of purchasing for safety.
  • Mechanisms underpinning the audit, including rectification, audit, monitoring.
  • Corrective and preventive action.
  • Report writing.
  • Presentation skills.

Relevant learning outcomes

# Outcome
# 4 Outcome Assist in and evaluate internal and external auditing of suppliers and/or contract manufacturers.