Competency information
Details
Place a batch in quarantine Observe the checks required on systems, pharmaceutical water and environment prior to product release
Considerations
- Range of in-process controls.
- The purpose and importance of in-process controls and testing.
- The purpose and requirements of quarantine and release procedures.
- EU Good Manufacturing Practice.
- Appreciate the need for in-house calibration.
- Importance of scheduling maintenance and calibrations, eg sterilisers, balances.
- Requirements of all Water for Injections (WFI) production and storage systems.
- Requirements of different grades of pharmaceutical water.
- Systems for:
- corrective actions and preventative actions (CAPA)
- investigation reports
- issuing of standard operating procedures (SOPs) and batch manufacturing records (BMRs)
- change control
- customer complaints
- deviations
- audit.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 4 | Outcome Perform all manufacturing activities in accordance with requirements for Good Manufacturing Practice and pharmaceutical management quality systems. |