Unit of competency Outline

Date retreived
22/07/2026 7:57 AM AWST

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Operate a pharmaceutical production process

Operate a pharmaceutical production process

Unit of competency
National Code
FBPPHM3021
State Code
ODX75
TGA Status
Current
DTWD Status
Approved
Current Release Number
1.00
Current Release Date
20/04/2022
View on TGA
State Implementation and Classification
Approved Date
08/07/2022
Field of Education
030399 - Process And Resources Engineering, N.e.c.
Original Release Date
08/07/2022
Nominal Hours
45
Description
This unit of competency describes the skills and knowledge required to setup, operate, monitor, adjust and shut down a production process in a pharmaceutical manufacturing facility.The unit applies to individuals who apply operating principles to the production process. Individuals work under broad direction and take responsibility for their own work.No licensing, legislative or certification requirements apply to this unit at the time of publication.
Notes
Elements and Performance Criteria
1. Move goods and components
  • 1.1 Confirm transfer of goods and components correspond to workplace documentation
  • 1.2 Clean and label containers with prescribed data, according to workplace procedures
  • 1.3 Quarantine goods and components according to release and reject status, Good Manufacturing Practice (GMP) requirements and workplace procedures'
  • 1.4 Identify and report deviations, unusual events and non-conformances according to GMP and workplace procedures
2. Set up the production process for operation
  • 2.1 Confirm equipment and materialsmeet production requirements and deliver materials in required quantities and sequence according to batch and production requirements
  • 2.2 Confirm cleaning requirements and equipment status
  • 2.3 Select and fit personal protective equipment and contamination prevention clothing according to workplace procedures
  • 2.4 Enter processing and operating parameters according to safety and production requirements
  • 2.5 Check and adjust equipment performance
  • 2.6 Conduct pre-start checks according to workplace procedures
3. Operate and monitor the production process
  • 3.1 Start up, monitor and control production process to maintain process within required limits
  • 3.2 Identify and report out of limit products or processes according to workplace procedures
  • 3.3 Maintain work area according to workplace cleaning standards
  • 3.4 Conduct production process according to safety and environmental requirements
  • 3.5 Complete documentation according to workplace procedures
4. Hand over the production process
  • 4.1 Perform handover according to workplace procedures
  • 4.2 Inform handover production team of process and related equipment status at completion of handover
5. Shut down the process
  • 5.1 Confirm the workplace procedures for shutting down the process
  • 5.2 Complete end-of-batch procedures according to batch instructions and workplace procedures
  • 5.3 Shut down the process according to workplace procedures and safety requirements
  • 5.4 Complete records according to workplace procedures
No information
No information
Replaces
State Code National Code Title Type
OAN86 FBPPHM3002 Operate a pharmaceutical production process Unit of competency