Competency information
Details
Assist in performing an internal or external audit of suppliers and/or contract manufacturers.
Considerations
- 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. |