Competency information
Details
Review/write an investigation report.
Considerations
- Process for completing:
- Corrective action and preventative action (CAPA).
- Investigation reports.
- Issuing of standard operating procedures (SOPs) and batch manufacturing records (BMRs).
- Change control.
- Customer complaints.
- Deviations.
- Audit.
- Levels of recall.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 4 | Outcome Perform all manufacturing activities in accordance with requirements for EU Good Manufacturing Practice and pharmaceutical management quality systems. |